A Research Study of an Investigational Drug ALO-02 (Oxycodone Hydrochloride and Naltrexone Hydrochloride) in Patients With Moderate to Severe Chronic Low Back Pain

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01571362
• Collaborator: (none)
• Enrollment: 410
• Locations: 52
• Arms: 2
• Duration (Months): 12
• Patients Per Site: 7.9
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

The primary objective of the study is to determine the analgesic efficacy and safety of ALO-02 extended-release capsules, when compared to placebo, in subjects with moderate to severe chronic low back pain.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain; Low Back Pain; Analgesia	Drug: ALO-02; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 410 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multicenter, 12 Week, Double-blind, Placebo-controlled, Randomized Withdrawal Study To Determine The Efficacy And Safety Of Alo-02 (Oxycodone Hydrochloride And Naltrexone Hydrochloride) Extended-release Capsules In Subjects With Moderate To Severe Chronic Low Back Pain
• Study Start Date: Jun 1, 2012
• Actual Primary Completion Date: Jun 1, 2013
• Actual Study Completion Date: Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ALO-02	Drug: ALO-02; 20 to 160mg total daily dose of oxycodone, divided into symmetric doses and administered twice daily; Other Names: oxycodone HCl and naltrexone HCl
Placebo Comparator: Placebo	Drug: Placebo; oral placebo, divided into symmetric doses and administered twice daily

Outcome Measures

Primary Outcome Measures

1. Change in Weekly Average Electronic Diary (eDiary) Numeric Rating Scale -Pain (NRS-Pain) Score From Randomization Baseline to Final 2 Weeks (Average of Weeks 11 and 12) [Weeks 11 and 12]

   Weekly average diary NRS-Pain scores were derived from the daily NRS-pain scale and calculated as the mean of the last 7 days. NRS-Pain scores based on an 11-point numerical rating scale from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain.

Secondary Outcome Measures

1. Change in Roland-Morris Disability Questionnaire (RMDQ) Total Score From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit). [Week 12]

   The RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain. An individual participant's score can vary from 0 (no disability) to 24 (severe disability), with a lower score indicating better function; higher score indicating greater disability.

2. Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). [Randomization Baseline, Week 12]

   Measure represents the score at Randomization Baseline / score at Week 12 (or Early Termination) in PGA, a global evaluation that utilizes a 5-point Likert scale with a score of 1 being the best (Very Good) and a score of 5 being the worst (Very Poor).

3. Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction of Greater or Equal to (≥) 20% [Weeks 11 and 12]

   Weekly average Diary NRS-pain scores are derived from the daily pain NRS and calculated as the mean of the last 7 days. Scores range from 0 equals (=) no pain to 10 = worst possible pain. Higher scores indicate greater pain.

4. Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction ≥30% [Weeks 11 and 12]

   Weekly average Diary NRS-pain scores are derived from the daily pain NRS and calculated as the mean of the last 7 days. Scores range from 0 = no pain to 10 = worst possible pain. Higher scores indicate greater pain.

5. Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction ≥40% [Weeks 11 and 12]

   Weekly average Diary NRS-pain scores are derived from the daily pain NRS and calculated as the mean of the last 7 days. Scores range from 0 = no pain to 10 = worst possible pain. Higher scores indicate greater pain.

6. Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction ≥50% [Weeks 11 and 12]

   Weekly average Diary NRS-pain scores are derived from the daily pain NRS and calculated as the mean of the last 7 days. Scores range from 0 = no pain to 10 = worst possible pain. Higher scores indicate greater pain.

7. Change From Screening Period to End of Open-Label Treatment in Brief Pain Inventory - Short Form (BPI-sf): Worst Pain, Least Pain, Average Pain, Pain Right Now, Pain Severity Index, Pain Interference Index [Screening, Week 4, 5, or 6]

   BPI-sf is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI-sf includes 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. Pain Severity Index is the mean of the 4 pain scores (worst, least, average, and right now) on the BPI-sf; range is 0=No pain to 10=Pain as bad as you can imagine; A higher score indicates greater pain severity. Pain Interference Index is the mean of the scores for the 7 items of the BPI-sf; range is 0=Does not interfere to 10=Completely interferes.

8. Change From Screening Period to Randomization Baseline in BPI-sf: Worst Pain, Least Pain, Average Pain, Pain Right Now, Pain Severity Index, Pain Interference Index [Screening, Randomization Baseline]

   BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. Pain Severity Index is the mean of the 4 pain scores (worst, least, average, and right now) on the BPI-sf; range is 0=No pain to 10=Pain as bad as you can imagine; A higher score indicates greater pain severity. Pain Interference Index is the mean of the scores for the 7 items of the BPI-sf; range is 0=Does not interfere to 10=Completely interferes.

9. Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Worst Pain [Weeks 2, 4, 8, and 12]

   BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.

10. Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Least Pain [Weeks 2, 4, 8, and 12]

    BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.

11. Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Average Pain [Weeks 2, 4, 8, and 12]

    BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.

12. Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Right Now [Weeks 2, 4, 8, and 12]

    BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.

13. Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Severity Index [Weeks 2, 4, 8, and 12]

    Pain Severity Index is the mean of the 4 pain scores (worst, least, average, and right now) on the BPI-sf; range is 0=No pain to 10=Pain as bad as you can imagine; a higher score indicates greater pain severity.

14. Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Interference Index [Weeks 2, 4, 8, and 12]

    Pain Interference Index is the mean of the scores for the 7 items of the BPI-sf; range is 0=Does not interfere to 10=Completely interferes.

15. Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Worst Pain [Weeks 2, 4, 8 and 12]

    BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.

16. Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Least Pain [Weeks 2, 4, 8, and 12]

    BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.

17. Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Average Pain [Weeks 2, 4, 8, and 12]

    BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; higher scores indicate greater pain.

18. Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Right Now [Weeks 2, 4, 8, and 12]

    BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; higher scores indicate greater pain.

19. Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Severity Index [Weeks 2, 4, 8, and 12]

    Pain Severity Index is the mean of the 4 pain scores (worst, least, average, and right now) on the BPI-sf; range is 0=No pain to 10=Pain as bad as you can imagine; a higher score indicates greater pain severity.

20. Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Interference Index [Weeks 2, 4, 8, and 12]

    Pain Interference Index is the mean of the scores for the 7 items of the BPI-sf; range is 0=Does not interfere to 10=Completely interferes.

21. Area Under the Curve (AUC) of eDiary NRS-Pain Scores From Randomization Baseline to Final 2 Weeks of the Double-Blind Treatment Period (Weeks 11 and 12) [Randomization Baseline, Weeks 11 and 12]

    NRS-Pain scores based on an 11-point numerical rating scale from 0 (no pain) to 10 (worst possible pain). AUC was calculated using daily change from Baseline scores from Baseline until the last dose date in the Double-Blind Treatment Period. AUC was calculated for each participant using the linear trapezoidal method. Higher scores indicate greater pain.

22. Average Daily Use of Rescue Acetaminophen (Milligrams Per Day [mg/Day]) During the Double-Blind Treatment Period [Daily from Day 1 of the Double-Blind Period through Week 12]

    The amount of acetaminophen administered for each treatment during the Double-Blind Treatment Period. Average daily use calculated as: total dose of rescue medication during Double-Blind Period divided by the number of days in Double-Blind Period.

23. Percentage of Participants With a 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to End of Open-Label Treatment [Screening, Week 4, 5 or 6]

    The percentage of analgesic response is defined as: (rolling 7-day mean pain score during Titration Period - Screening Period pain intensity score) divided by Screening Period pain intensity score times100.

24. Median Time to 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to End of Open-Label Treatment [Screening, Week 4, 5, or 6]

    The percentage of analgesic response is defined as: (rolling 7-day mean pain score during Titration Period minus (-) Screening Period pain intensity score) divided by Screening Period pain intensity score times 100. An event was defined as a participant with 20, 30, 40, or 50% analgesic response from Screening. If there was no event for a participant, time to the event was considered censored at Day 42 of the Titration Period or before Day 42 of the Titration Period at the time of the last diary pain score. The survival duration begins on the date of first dose of study drug in the Titration Period and is calculated as the [date of event or last diary pain score - date of first dose in Titration Period +1].

25. Percentage of Participants With a 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to Randomization Baseline [Screening, Randomization Baseline (up to 6 weeks)]

    The percentage of analgesic response is defined as: (rolling 7-day mean pain score during Titration Period - Screening Period pain intensity score) divided by Screening Period pain intensity score times 100.

26. Median Time to 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to Randomization Baseline [Screening, Randomization Baseline (up to 6 weeks)]

    The percentage of analgesic response is defined as: (rolling 7-day mean pain score during Titration Period - Screening Period pain intensity score) divided by Screening Period pain intensity score times 100. If there was no event for a participant, time to the event was considered censored at Day 42 of the Titration Period or before Day 42 of the Titration Period at the time of the last diary pain score. The survival duration begins on the date of first dose of study drug in the Titration Period and is calculated as the [date of event or last diary pain score - date of first dose in Titration Period +1].

27. Percentage of Participants With a 20%, 30%, 40%, or 50% Loss of Analgesic Response From Randomization Baseline During the Double-Blind Treatment Period [Randomization Baseline, up to Week 12]

    The percentage of lost analgesic response is defined as: (rolling 7-day mean pain score during Double-Blind Period - Randomization Baseline pain intensity score) divided by Randomization Baseline pain intensity score times 100. If there was no event for a participant, time to the event was considered censored at Day 84 or before Day 84 at the time of the last diary pain score. The survival duration began on the date of first dose of study drug in the Double-Blind Period and was calculated as the [date of event or last diary pain score - date of first dose in Double-Blind Treatment +1].

28. Median Time to 20%, 30%, 40%, or 50% Loss of Analgesic Response From Baseline During the Double-Blind Treatment Period [Randomization Baseline, up to Week 12]

    The percentage of lost analgesic response was defined as: (rolling seven day mean pain score during Double-Blind Period - Randomization Baseline pain intensity score) divided by Randomization Baseline pain intensity score times 100. If there was no event for a participant, time to the event was considered censored at Day 84 or before Day 84 at the time of the last diary pain score. The survival duration began on the date of first dose of study drug in the Double-Blind Period and was calculated as the [date of event or last diary pain score - date of first dose in Double-Blind Treatment +1].

29. Percentage of Participants Discontinuing Treatment for Investigator-Reported Lack of Efficacy [Week 1 up to Week 12]

    If there was no event for a participant, time to the event was considered censored at Day 84 or before Day 84 at time of treatment discontinuation for another reason.

30. Median Time to Treatment Discontinuation for Investigator-Reported Lack of Efficacy During the Double-Blind Treatment Period [Week 1 up to Week 12]

    If there was no event for a participant, time to the event was considered censored at Day 84 or before Day 84 at time of treatment discontinuation for another reason. The survival duration begins on the date of first dose in the Double-Blind period and is calculated as the [date of event or discontinuation - date of first dose in Double-Blind Period +1].

31. Clinical Opiate Withdrawal Scale (COWS) Total Score During the Open-Label Titration Period [Screening, Weeks 1, 2, 3, 4, 5, and 6]

    The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. Higher scores indicate a worse outcome. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal.

32. COWS Total Score During the Double-Blind Treatment Period [Randomization Baseline, Weeks 1, 2, 4, 8, and 12]

    The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. Higher scores indicate a worse outcome. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal.

33. COWS Total Score During the Post-Treatment Period [Follow-Up (FU) Weeks 1 and 2]

    The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. Higher scores indicate a worse outcome. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal.

34. Percentage of Participants With Opiate Withdrawal During the Open-Label Titration Period by COWS Category [Screening, Weeks 1, 2, 3, 4, 5, 6 (or Early Termination)]

    The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal. The scores are assessed as follows: 5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal.

35. Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category [Randomization Baseline, Weeks 1, 2, 4, 8, 12 (or Early Termination)]

    The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal. The scores are assessed as follows: 5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal.

36. Percentage of Participants With Opiate Withdrawal During Post-Treatment by COWS Category [Follow-Up Weeks 1 and 2]

    The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal. The scores are assessed as follows: 5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal.

37. Subjective Opiate Withdrawal Scale (SOWS) During the Open-Label Titration Period [Screening, Weeks 1, 2, 3, 4, 5, and 6]

    The SOWS was completed daily by the participant during any of the 2-week tapers from study drug, as well as at each study visit, using an eDiary device, and contains 16 symptoms of opiate withdrawal rated by the participant (Scale of 0 to 4: 0 = not at all, 1 = a little, 2= moderately, 3= quite a bit, 4 = extremely). The sum of the scores on each item was the total SOWS score; the minimum possible SOWS score was 0, the maximum 64. Higher scores indicate a worse outcome.

38. SOWS Total Score During the Double-Blind Treatment Period [Randomization Baseline, Weeks 1, 2, 4, 8, and 12]

    The SOWS was completed daily by the participant during any of the 2-week tapers from study drug, as well as at each study visit, using an eDiary device, and contains 16 symptoms of opiate withdrawal rated by the participant (Scale of 0 to 4: 0 = not at all, 1 = a little, 2= moderately, 3= quite a bit, 4 = extremely). The sum of the scores on each item was the total SOWS score; the minimum possible SOWS score was 0, the maximum 64. Higher scores indicate a worse outcome.

39. SOWS Total Score During the Post-Treatment Period [Follow-Up Weeks 1 and 2]

    The SOWS was completed daily by the participant during any of the 2-week tapers from study drug, as well as at each study visit, using an eDiary device, and contains 16 symptoms of opiate withdrawal rated by the participant (Scale of 0 to 4: 0 = not at all, 1 = a little, 2= moderately, 3= quite a bit, 4 = extremely). The sum of the scores on each item was the total SOWS score; the minimum possible SOWS score was 0, the maximum 64. Higher scores indicate a worse outcome.

40. Change From Screening Period to End of Open-Label Titration Period in Roland-Morris Disability Questionnaire (RMDQ) Total Score for All Participants [Screening, Week 6 (or Early Termination)]

    RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain the same day the questionnaire is completed. An individual participant's score could have ranged from 0 (no disability) to 24 (severe disability), with a lower score indicating better function; higher scores indicating greater disability.

41. Change From Screening Period to Randomization Baseline in RMDQ Total Score [Screening, Randomization Baseline]

    RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain the same day the questionnaire is completed. An individual participant's score could have ranged from 0 (no disability) to 24 (severe disability), with a lower score indicating better function.

42. Change From Screening Period to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in RMDQ Total Score [Screening, Weeks 2, 4, 8, and 12]

    RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain the same day the questionnaire is completed. An individual participant's score could have ranged from 0 (no disability) to 24 (severe disability), with a lower score indicating better function.

43. Change From Randomization Baseline to the End of Double-Blind Weeks 2, 4, and 8 in RMDQ Total Score [Randomization Baseline, Weeks 2, 4, and 8]

    RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain the same day the questionnaire is completed. An individual participant's score could have ranged from 0 (no disability) to 24 (severe disability), with a lower score indicating better function.

44. Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor [Screening, Randomization Baseline]

    Represents the score at Screening / score at Randomization Baseline in PGA of low back pain, a global evaluation that utilizes a 5-point Likert scale with a score of: 1 = very good, asymptomatic and no limitation of normal activities; 2 = good, mild symptoms, and no limitation of normal activities; 3 = fair, moderate symptoms and limitation to some normal activities; 4 = poor, severe symptoms and inability to carry out most normal activities; and a score of 5 = very poor; very severe symptoms, which were intolerable and inability to carry out all normal activities.

45. Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor [Screening, Randomization Baseline, or Early Termination]

    Represents the score at Screening / score at to end of the titration period in PGA of low back pain, a global evaluation that utilizes a 5-point Likert scale with a score of: 1 = very good, asymptomatic and no limitation of normal activities; 2 = good, mild symptoms, and no limitation of normal activities; 3 = fair, moderate symptoms and limitation to some normal activities; 4 = poor, severe symptoms and inability to carry out most normal activities; and a score of 5 = very poor; very severe symptoms, which were intolerable and inability to carry out all normal activities.

46. Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor [Randomization Baseline, Week 4]

    Represents the score at Randomization Baseline / score at Week 4 in PGA of low back pain, a global evaluation that utilizes a 5-point Likert scale with a score of: 1 = very good, asymptomatic and no limitation of normal activities; 2 = good, mild symptoms, and no limitation of normal activities; 3 = fair, moderate symptoms and limitation to some normal activities; 4 = poor, severe symptoms and inability to carry out most normal activities; and a score of 5 = very poor; very severe symptoms, which were intolerable and inability to carry out all normal activities.

47. Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor [Randomization Baseline, Week 8]

    Represents the score at Randomization Baseline / score at Week 8 in PGA of low back pain, a global evaluation that utilizes a 5-point Likert scale with a score of: 1 = very good, asymptomatic and no limitation of normal activities; 2 = good, mild symptoms, and no limitation of normal activities; 3 = fair, moderate symptoms and limitation to some normal activities; 4 = poor, severe symptoms and inability to carry out most normal activities; and a score of 5 = very poor; very severe symptoms, which were intolerable and inability to carry out all normal activities.

48. Satisfaction With Treatment at the End of Open-Label Titration Period for All Participants [End of Open-Label Titration Period (Week 4, 5, or 6 or Early Termination)]

    Satisfaction with treatment is a single-item self-rated instrument that measures the participant's overall satisfaction with the study drug during study participation on a 5-point likert scale ranging from 1 = Very dissatisfied to 5 = Very satisfied.

49. Satisfaction With Treatment at Randomization Baseline [Randomization Baseline]

    Satisfaction with treatment is a single-item self-rated instrument that measures the participant's overall satisfaction with the study drug during study participation on a 5-point likert scale ranging from 1 = Very dissatisfied to 5 = Very satisfied.

50. Percentage of Participants Who Reported Being Satisfied/Very Satisfied With Treatment on the Satisfaction With Treatment Questionnaire During the Double-Blind Treatment Period [Week 12 or Early Termination]

    Participants used an electronic tablet at the center to rate their overall treatment satisfaction with study drug during study participation using a 5-point categorical scale (1 = very dissatisfied, 2 = dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = satisfied, 5 = very satisfied).

51. Change From Screening Period to the End of Open-Label Titration Period in Short Form-36v2 (SF-36v2) Health Survey Score [Screening, Week 6 (or Early Termination)]

    SF-36v2 Health Survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health aspects; physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. These domains also combine to form two component summary scores evaluating mental health and physical health. The minimum score is 0 and the maximum score is 100. A higher scores indicates a better health state.

52. Change From Screening Period to Randomization Baseline in SF-36v2 Health Survey Score [Screening, Randomization Baseline]

    SF-36v2 Health Survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health aspects; physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. These domains also combine to form two component summary scores evaluating mental health and physical health. The minimum score is 0 and the maximum score is 100. A higher score indicate a better health state.

53. Change From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey [Randomization Baseline, Week 12]

    SF-36v2 Health Survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health aspects; physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. These domains also combine to form two component summary scores evaluating mental health and physical health. The minimum score is 0 and the maximum score is 100. A higher score indicate a better health state.

54. Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey [Screening, Week 12]

    SF-36v2 Health Survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health aspects; physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. These domains also combine to form two component summary scores evaluating mental health and physical health. The minimum score is 0 and the maximum score is 100. A higher score indicate a better health state.

55. Change From Screening Period to the End of Open-Label Titration Period in Participant Assessment of Overall Health State Using the EuroQol 5-Dimensions (EQ-5D) Summary Index [Screening, Week 6 (or Early Termination)]

    The EQ 5D Health Questionnaire is a self completion standardized instrument for use as a measure of health-related quality of life in terms of a single index value or utility score that consisted of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which was rated on a 3-point response scale (no problems/some or moderate problems/extreme problems), and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health.

56. Change From Screening Period to the End of Open-Label Titration Period in Participant Assessment of Overall Health State Using the EQ-5D VAS [Screening, Week 6 (or Early Termination)]

    The EQ-5D consists of a standard vertical 20cm visual analogue scale (EQ VAS), for recording a participant's rating for their current health related quality of life state; the scale went from 0 (worst imaginable health state) to 100 (best imaginable health state). Participants were asked to draw a line on the scale to indicate how good or bad your own health is today, in your opinion.

57. Change From Screening Period to Randomization Baseline in Participant Assessment of Overall Health State Using the EQ-5D Summary Index [Screening, Randomization Baseline]

    Self-completion standardized instrument for use as a measure of health-related quality of life in terms of a single index value or utility score that consisted of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which was rated on a 3-point response scale (no problems/some or moderate problems/extreme problems), and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health

58. Change From Screening Period to Randomization Baseline in Participant Assessment of Overall Health State Using the EQ-5D VAS [Screening, Randomization Baseline]

    The EQ-5D consists of a standard vertical 20cm visual analogue scale (EQ VAS), for recording a participant's rating for their current health related quality of life state; the scale went from 0 (worst imaginable health state) to 100 (best imaginable health state). Participants were asked to draw a line on the scale to indicate how good or bad your own health is today, in your opinion.

59. Change From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using EQ-5D Summary Index [Randomization Baseline, Week 12]

    Self-completion standardized instrument for use as a measure of health-related quality of life in terms of a single index value or utility score that consisted of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which was rated on a 3-point response scale (no problems/some or moderate problems/extreme problems), and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health

60. Change From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using the EQ-5D VAS [Randomization Baseline, Week 12]

    The EQ-5D consists of a standard vertical 20cm visual analogue scale (EQ VAS), for recording a participant's rating for their current health related quality of life state; the scale went from 0 (worst imaginable health state) to 100 (best imaginable health state). Participants were asked to draw a line on the scale to indicate how good or bad your own health is today, in your opinion.

61. Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using EQ-5D Summary Index [Screening, Week 12]

    Self-completion standardized instrument for use as a measure of health-related quality of life in terms of a single index value or utility score that consisted of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which was rated on a 3-point response scale (no problems/some or moderate problems/extreme problems), and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health.

62. Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using EQ-5D VAS [Screening, Week 12]

    The EQ-5D consists of a standard vertical 20cm visual analogue scale (EQ VAS), for recording a participant's rating for their current health related quality of life state; the scale went from 0 (worst imaginable health state) to 100 (best imaginable health state). Participants were asked to draw a line on the scale to indicate how good or bad your own health is today, in your opinion.

63. Change From Screening Period to End of Open-Label in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP): % Work Time Missed, % Impairment, % Overall Work Impairment, % Activity Impairment Due to Low Back Pain [Screening, Week 6 (or Early Termination)]

    A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment /absenteeism+presenteeism); and activity impairment. work time missed - a measure of absenteeism, calculated as work time missed due to health problem (question 2) as a proportion of hours actually worked (question 4). impairment while working - a measure of presenteeism, the degree to which health problem impacted work (question 5). overall work impairment - a measure of overall work productivity loss due to health problem (absenteeism+presenteeism). activity impairment - a measure of the degree to which health problem has affected ability to do regular activities other than work at a job (question 6). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity.

64. Change From Screening Period to Randomization Baseline in WPAI:SHP: Percent Work Time Missed, Percent Impairment, Percent Overall Work Impairment, Percent Activity Impairment Due to Low Back Pain [Screening, Randomization Baseline]

    A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. work time missed - a measure of absenteeism, calculated as work time missed due to health problem (question 2) as a proportion of hours actually worked (question 4). impairment while working - a measure of presenteeism, the degree to which health problem impacted work (question 5). overall work impairment - a measure of overall work productivity loss due to health problem (absenteeism+presenteeism). activity impairment - a measure of the degree to which health problem has affected ability to do regular activities other than work at a job (question 6). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity.

65. Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Work Time Missed Due to Low Back Pain [Randomization Baseline, Weeks 4, 8, and 12]

    A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % work time missed - a measure of absenteeism, calculated as work time missed due to health problem (question 2) as a proportion of hours actually worked (question 4). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity.

66. Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Impairment Due to Low Back Pain [Randomization Baseline, Weeks 4, 8, and 12]

    A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % impairment while working - a measure of presenteeism, the degree to which health problem impacted work (question 5). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity.

67. Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Overall Work Impairment Due to Low Back Pain [Randomization Baseline, Weeks 4, 8, and 12]

    A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % overall work impairment - a measure of overall work productivity loss due to health problem (absenteeism+presenteeism). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity.

68. Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Activity Impairment Due to Low Back Pain [Randomization Baseline, Weeks 4, 8, and 12]

    A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % activity impairment - a measure of the degree to which health problem has affected ability to do regular activities other than work at a job (question 6). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity.

69. Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Work Time Missed Due to Low Back Pain [Screening, Weeks 4, 8, and 12]

    A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % work time missed - a measure of absenteeism, calculated as work time missed due to health problem (question 2) as a proportion of hours actually worked (question 4). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity.

70. Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Impairment Due to Low Back Pain [Screening, Weeks 4, 8, and 12]

    A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % impairment while working - a measure of presenteeism, the degree to which health problem impacted work (question 5). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity.

71. Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Overall Work Impairment Due to Low Back Pain [Screening, Weeks 4, 8, and 12]

    A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % overall work impairment - a measure of overall work productivity loss due to health problem (absenteeism+presenteeism). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity.

72. Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Activity Impairment Due to Low Back Pain [Screening, Weeks 4, 8, and 12]

    A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % activity impairment - a measure of the degree to which health problem has affected ability to do regular activities other than work at a job (question 6). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity.

73. Percentage of Participants With Shift From Screening Period to End of Open-Label Titration Period in Hospitalization Because of Low Back Pain as Assessed Using the Healthcare Resource Use (HRU) Questionnaire [Screening, Week 6 (or Early Termination)]

    Question 3a = In the past 4 weeks, have you been hospitalized due to chronic low back pain or any medication used for chronic low back pain?

74. Percentage of Participants With Shift From Screening Period to Randomization Baseline in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire [Screening, Randomization Baseline]

    Question 3a = In the past 4 weeks, have you been hospitalized due to chronic low back pain or any medication used for chronic low back pain?

75. Change From Screening to Randomization Baseline in HRU Questionnaire: Number of Office Visits Directly Related or Any Medication Used for Chronic Low Back Pain [Screening, Randomization Baseline]

    Question 1: number of office visits directly related to chronic low back pain or any medication used for chronic low back pain.

76. Change From Screening to Randomization Baseline in HRU Questionnaire: Money Spent on Physical Treatments in Past 4 Weeks [Screening, Randomization Baseline]

    Question 2: Money (dollars) spent out-of-pocket on physical treatments in the past 4 weeks to manage chronic low back pain

77. Change From Screening to Randomization Baseline in HRU Questionnaire: Nights Stayed in Hospital [Screening, Randomization Baseline]

    Question 3b: nights stayed in the hospital, if answer to Q3a was yes.

78. Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Number of Office Visits Directly Related or Any Medication Used for Chronic Low Back Pain [Screening, Week 6 (or Early Termination)]

    Question 1: number of office visits directly related to chronic low back pain or any medication used for chronic low back pain.

79. Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Money Spent on Physical Treatments in Past 4 Weeks [Screening, Week 6 (or Early Termination)]

    Question 2: Money (dollars) spent out-of-pocket on physical treatments in the past 4 weeks to manage chronic low back pain

80. Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Nights Stayed in Hospital [Screening, Week 6 (or Early Termination)]

    Question 3b: nights stayed in the hospital, if answer to Q3a was yes.

81. Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire [Randomization Baseline, Weeks 4, 8, and 12 (or Early Termination)]

    Question 3a = In the past 4 weeks, have you been hospitalized due to chronic low back pain or any medication used for chronic low back pain?

82. Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related to or Medications Used for Chronic Low Back Pain [Randomization Baseline, Weeks 4, 8, and 12]

    Question 1: number of office visits directly related to chronic low back pain or any medication used for chronic low back pain

83. Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatments [Randomization Baseline, Weeks 4, 8, and 12]

    Question 2: money (dollars) spent out-of-pocket on physical treatments in the past 4 weeks to manage chronic low back pain.

84. Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights Spent in Hospital [Randomization Baseline, Weeks 4, 8, and 12]

    Question 3b: nights stayed in the hospital

85. Percentage of Participants With Shift From Screening Period to the End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire [Screening, Weeks 4, 8, and 12]

    Question 3a = In the past 4 weeks, have you been hospitalized due to chronic low back pain or any medication used for chronic low back pain?

86. Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related or Medication Used for Chronic Low Back Pain [Screening, Weeks 4, 8, and 12]

    Question 1: number of office visits directly related to chronic low back pain or any medication used for chronic low back pain

87. Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatment for Chronic Low Back Pain [Screening, Weeks 4, 8, and 12]

    Question 2: money (dollars) spent out-of-pocket on physical treatments in the past 4 weeks to manage chronic low back pain

88. Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights in Hospital for Chronic Low Back Pain [Screening, Weeks 4, 8, and 12]

    Question 3b: nights stayed in the hospital

89. Mean Oxycodone Average Daily Dose During the Open-Label Titration Period [Open-Label Period]

90. Mean Oxycodone Duration of Titration During the Open-Label Titration Period [Open-Label Period]

91. Median Oxycodone Average Daily Dose During the Open-Label Titration Period [Open-Label Period]

92. Median Oxycodone Duration of Titration During the Open-Label Titration Period [Open-Label Period]

93. Mean Oxycodone Average Daily Dose During the Double-Blind Treatment Period [Double-Blind Period]

94. Mean Oxycodone Duration of Treatment During the Double-Blind Treatment Period [Double-Blind Period]

95. Median Oxycodone Average Daily Dose During the Double-Blind Treatment Period [Double-Blind Period]

96. Median Oxycodone Duration of Treatment During the Double-Blind Treatment Period [Double-Blind Period]

97. Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Titration Period [Blood samples were taken within +/-4 hours of the morning dose of ALO-02 at Week 6/Early Termination, Randomization Baseline]

    Observed steady-state plasma concentration (Cobs) of oxycodone and noroxycodone.

98. Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Titration Period [Blood samples were taken within +/-4 hours of the morning dose of ALO-02 at Week 6/Early Termination, Randomization Baseline]

    Cobs of naltrexone and 6-β-naltrexol

99. Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Double-Blind Treatment Period [Blood samples were taken within +/-4 hours of the morning dose of study drug at Randomization Baseline, Weeks 4, 8, and 12]

    Observed steady-state plasma concentration (Cobs) of oxycodone and noroxycodone

100. Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Double Blind Treatment Period [Blood samples were taken within +/-4 hours of the morning dose of study drug at Randomization Baseline, Weeks 4, 8, and 12]

     Observed steady-state plasma concentration (Cobs) of naltrexone and 6-β-naltrexol

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Moderate-to-severe chronic low back pain present for at least 3 months.

• Require a continuous around-the-clock opioid analgesic for an extended period of time.

• Refrain from taking other opioid and non-opioid medications during the study.

Exclusion Criteria:

• Active or within a past 2 years a history of lumbosacral radiculopathy or chronic low back pain due to other underlying disorders such as spinal stenosis with neurologic impairment, cancer, infection, or post-surgical intervention.

• Documented diagnosis of ongoing pain due to other chronic pain conditions which may interfere with assessment of chronic low back pain.

• Active or ongoing or history of alcohol or drug abuse.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Coastal Clinical Research, Inc.	Mobile	Alabama	United States	36608
2	Dedicated Clinical Research	Goodyear	Arizona	United States	85395
3	Arizona Research Center	Phoenix	Arizona	United States	85023
4	Premier Research Group Limited	Phoenix	Arizona	United States	85027
5	Anaheim Clinical Trials, LLC	Anaheim	California	United States	92801
6	Med Center	Carmichael	California	United States	95608
7	Med Investigations, Inc.	Fair Oaks	California	United States	95628
8	Neuro-Pain Medical Center	Fresno	California	United States	93710
9	Pacific Coast Pain Management Center	Laguna Hills	California	United States	92637
10	Long Beach Center for Clinical Research - previous addresse	Long Beach	California	United States	90806
11	Long Beach Center for Clinical Research	Long Beach	California	United States	90807
12	Providence Clinical Research	North Hollywood	California	United States	91606
13	Clinicos, LLC	Colorado Springs	Colorado	United States	80904
14	Lynn Institute of the Rockies Medical Centre	Colorado Springs	Colorado	United States	80907
15	Avail Clinical Research, LLC	DeLand	Florida	United States	32720
16	Ormond Medical Arts pharmaceutical Research Center	Ormond Beach	Florida	United States	32174
17	Gold Coast Research, LLC	Plantation	Florida	United States	33317
18	The Office of Martin E. Hale, MD, PA	Plantation	Florida	United States	33317
19	Accord Clinical Research, LLC- Duplicate 2	Port Orange	Florida	United States	32129
20	Accord Clinical Research, LLC- Duplicate	Port Orange	Florida	United States	32129
21	Clinical Research of West Florida	Tampa	Florida	United States	33603
22	Palm Beach Research Center	West Palm Beach	Florida	United States	33409
23	Drug Studies America	Marietta	Georgia	United States	30060
24	Georgia Institute for Clinical Research, LLC	Marietta	Georgia	United States	30060
25	MediSphere Medical Research Center, LLC	Evansville	Indiana	United States	47714
26	Mid-Atlantic Medical Research - Research Department	Hollywood	Maryland	United States	20636
27	Clinical Pharmacology Study Group	Worcester	Massachusetts	United States	01605
28	Mercy Health Research	St. Louis	Missouri	United States	63141
29	Heartland Clinical Research, Inc.	Omaha	Nebraska	United States	68134
30	Office of Stephen H. Miller, M.D.	Las Vegas	Nevada	United States	89144
31	Albuquerque Clinical Trials, Inc.	Albuquerque	New Mexico	United States	87102
32	Drug Trials America	Hartsdale	New York	United States	10530
33	Mid Hudson Medical Research, PLLC	New Windsor	New York	United States	12553
34	Research Across America	New York	New York	United States	10022
35	Upstate Clinical Research Associates, LLC	Williamsville	New York	United States	14221
36	The Center for Clinical Research	Winston-Salem	North Carolina	United States	27103
37	Community Research	Cincinnati	Ohio	United States	45227
38	Columbus Clinical Research	Columbus	Ohio	United States	43213
39	Lynn Health Science Institute	Oklahoma City	Oklahoma	United States	73112
40	Associated Orthopedics	Oklahoma City	Oklahoma	United States	73119
41	Hillcrest Clinical Research	Oklahoma City	Oklahoma	United States	73119
42	Allegheny Pain Management, PC	Altoona	Pennsylvania	United States	16602
43	Altoona Center for Clinical Research	Duncansville	Pennsylvania	United States	16635
44	Omega Medical Research	Warwick	Rhode Island	United States	02886
45	Pain Research of Charleston	Charleston	South Carolina	United States	29406
46	TLM Medical Services	Columbia	South Carolina	United States	29204
47	FutureSearch Trials of Neurology	Austin	Texas	United States	78731
48	KRK Medical Research	Dallas	Texas	United States	75230
49	FutureSearch Trials of Dallas, LP	Dallas	Texas	United States	75231
50	Quality Research Inc.	San Antonio	Texas	United States	78209
51	Lee Medical Associates	San Antonio	Texas	United States	78229
52	Progressive Clinical Research, P.A.	San Antonio	Texas	United States	78229

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01571362
• Other Study ID Numbers: B4531002; B4531002; ALO-02-10-3002
• First Posted: Apr 5, 2012
• Last Update Posted: Apr 4, 2017
• Last Verified: Feb 1, 2017

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Pfizer: oxycodone; naltrexone; chronic pain; low back pain
• Additional relevant MeSH terms: Back Pain; Low Back Pain; Chronic Pain; Naltrexone; Oxycodone

Study Results

Participant Flow

Recruitment Details	A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Determine the Efficacy and Safety of ALO-02 Extended-Release Capsules in participants with Moderate to Severe Chronic Low Back Pain
Pre-assignment Detail	A total of 410 participants were enrolled into the Open-Label Conversion and Titration Period and 281 participants were randomized into the Double-Blind Treatment Period, of which, 280 participants received study treatment.

Arm/Group Title	Open ALO-02	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules, orally (PO), twice daily (BID), at total daily doses of oxycodone from 20 to 160 milligrams (mg) in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Period Title: Open-Label Conversion + Titration Period
STARTED	410	0	0
COMPLETED	281	0	0
NOT COMPLETED	129	0	0
Period Title: Open-Label Conversion + Titration Period
STARTED	0	134	146
COMPLETED	0	81	107
NOT COMPLETED	0	53	39

Baseline Characteristics

Arm/Group Title	Open ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
Overall Participants	410
Age, Customized (Number) [Number]
Between 18 and 65 years	364 88.8%
>=65 years	46 11.2%
Sex: Female, Male (Count of Participants)
Female	233 56.8%
Male	177 43.2%

Outcome Measures

1. Primary Outcome

Title	Change in Weekly Average Electronic Diary (eDiary) Numeric Rating Scale -Pain (NRS-Pain) Score From Randomization Baseline to Final 2 Weeks (Average of Weeks 11 and 12)
Description	Weekly average diary NRS-Pain scores were derived from the daily NRS-pain scale and calculated as the mean of the last 7 days. NRS-Pain scores based on an 11-point numerical rating scale from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain.
Time Frame	Weeks 11 and 12

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT) Population: all participants who were randomized into the Double-Blind Treatment Period and received at least 1 dose of study drug after randomization; the averaged value for each participant from the 100 imputed datasets were used. Hybrid multiple and single imputation were applied, depending on reason for discontinuation.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	133	145
Least Squares Mean (Standard Error) [Units on a Scale]	1.23 (0.179)	0.60 (0.168)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Null Hypothesis: No treatment difference. Power was 90%, 2-sided Alpha of 0.05, with assumed difference of 1 point and assumed standard deviation of 2.4 points.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0114
	Comments	No adjustment was made for multiple comparisons. Statistical significance was if unadjusted p was less than or equal to (<=) 0.05.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.62
	Confidence Interval	(2-Sided) 95%; -1.11 to -0.14
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.246
	Estimation Comments

2. Secondary Outcome

Title	Change in Roland-Morris Disability Questionnaire (RMDQ) Total Score From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit).
Description	The RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain. An individual participant's score can vary from 0 (no disability) to 24 (severe disability), with a lower score indicating better function; higher score indicating greater disability.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

ITT Population; imputation using last observation carried forward (LOCF) method.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	118	122
Least Squares Mean (Standard Error) [Units on a Scale]	0.50 (0.404)	0.67 (0.393)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7547
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and Baseline score and final total daily dose of Titration Period as covariates.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	0.18
	Confidence Interval	(2-Sided) 95%; -0.94 to 1.29
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.565
	Estimation Comments

3. Secondary Outcome

Title	Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit).
Description	Measure represents the score at Randomization Baseline / score at Week 12 (or Early Termination) in PGA, a global evaluation that utilizes a 5-point Likert scale with a score of 1 being the best (Very Good) and a score of 5 being the worst (Very Poor).
Time Frame	Randomization Baseline, Week 12

Outcome Measure Data

Analysis Population Description

ITT Population; percentage based on the number of participants who had non-missing values at Randomization Baseline and Week 12/early termination for each treatment. Imputation using LOCF method.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	130	137
Very Good / Very Good	5.4 1.3%	11.7 NaN
Very Good / Good	6.2 1.5%	2.9 NaN
Very Good / Fair	1.5 0.4%	1.5 NaN
Very Good / Poor	0.8 0.2%	0.0 NaN
Very Good / Very Poor	0.0 0%	0.0 NaN
Good / Very Good	6.2 1.5%	3.6 NaN
Good / Good	18.5 4.5%	19.7 NaN
Good / Fair	4.6 1.1%	6.6 NaN
Good / Poor	0.0 0%	0.7 NaN
Good / Very Poor	0.0 0%	0.0 NaN
Fair / Very Good	3.1 0.8%	0.0 NaN
Fair / Good	17.7 4.3%	21.2 NaN
Fair / Fair	23.1 5.6%	26.3 NaN
Fair / Poor	0.8 0.2%	2.2 NaN
Fair / Very Poor	0.0 0%	0.0 NaN
Poor / Very Good	0.8 0.2%	0.0 NaN
Poor / Good	2.3 0.6%	1.5 NaN
Poor / Fair	4.6 1.1%	2.2 NaN
Poor / Poor	1.5 0.4%	0.0 NaN
Poor / Very Poor	0.0 0%	0.0 NaN
Very Poor / Very Good	0.0 0%	0.0 NaN
Very Poor / Good	1.5 0.4%	0.0 NaN
Very Poor / Fair	1.5 0.4%	0.0 NaN
Very Poor / Poor	0.0 0%	0.0 NaN
Very Poor / Very Poor	0.0 0%	0.0 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1272
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Cochran-Mantel-Haenszel (CMH) stratified by prior pain analgesic (opioid or non-opioid)

4. Secondary Outcome

Title	Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction of Greater or Equal to (≥) 20%
Description	Weekly average Diary NRS-pain scores are derived from the daily pain NRS and calculated as the mean of the last 7 days. Scores range from 0 equals (=) no pain to 10 = worst possible pain. Higher scores indicate greater pain.
Time Frame	Weeks 11 and 12

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	134	146
Number [percentage of participants]	48.5 11.8%	62.3 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0210
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	CMH was stratified by prior pain analgesic (opioid and non-opioid).

5. Secondary Outcome

Title	Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction ≥30%
Description	Weekly average Diary NRS-pain scores are derived from the daily pain NRS and calculated as the mean of the last 7 days. Scores range from 0 = no pain to 10 = worst possible pain. Higher scores indicate greater pain.
Time Frame	Weeks 11 and 12

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	134	146
Number [percentage of participants]	44.0 10.7%	57.5 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0248
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	The CMH test was stratified by prior pain analgesic (opioid or non-opioid).

6. Secondary Outcome

Title	Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction ≥40%
Description	Weekly average Diary NRS-pain scores are derived from the daily pain NRS and calculated as the mean of the last 7 days. Scores range from 0 = no pain to 10 = worst possible pain. Higher scores indicate greater pain.
Time Frame	Weeks 11 and 12

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	134	146
Number [percentage of participants]	35.1 8.6%	50.7 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0090
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	The CMH test was stratified by prior pain analgesic (opioid or non-opioid).

7. Secondary Outcome

Title	Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction ≥50%
Description	Weekly average Diary NRS-pain scores are derived from the daily pain NRS and calculated as the mean of the last 7 days. Scores range from 0 = no pain to 10 = worst possible pain. Higher scores indicate greater pain.
Time Frame	Weeks 11 and 12

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	134	146
Number [percentage of participants]	29.9 7.3%	39.7 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0874
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	The CMH test was stratified by prior pain analgesic (opioid or non-opioid).

8. Secondary Outcome

Title	Change From Screening Period to End of Open-Label Treatment in Brief Pain Inventory - Short Form (BPI-sf): Worst Pain, Least Pain, Average Pain, Pain Right Now, Pain Severity Index, Pain Interference Index
Description	BPI-sf is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI-sf includes 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. Pain Severity Index is the mean of the 4 pain scores (worst, least, average, and right now) on the BPI-sf; range is 0=No pain to 10=Pain as bad as you can imagine; A higher score indicates greater pain severity. Pain Interference Index is the mean of the scores for the 7 items of the BPI-sf; range is 0=Does not interfere to 10=Completely interferes.
Time Frame	Screening, Week 4, 5, or 6

Outcome Measure Data

Analysis Population Description

Titration Period Safety Population: defined as all participants who received any amount of ALO-02 capsules during the Open-Label Conversion and Titration Period; imputation using the LOCF method. n=number of participants contributing to the mean for the specified parameter.

Arm/Group Title	Open ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
Measure Participants	410
Worst Pain Score (n=400)	-3.3 (2.30)
Least Pain Score (n=400)	-2.6 (2.33)
Average Pain Score (n=400)	-3.0 (2.11)
Pain Right Now (n=400)	-3.3 (2.41)
Pain Severity Index (n=400)	-3.1 (2.07)
Pain Interference Index (n=401)	-2.8 (2.32)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo
	Comments	Change from Screening Period value to end of the OL Period for Worst Pain Score
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo
	Comments	Change from Screening Period value to end of the OL Period for Least Pain Score
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo
	Comments	Change from Screening Period value to end of the OL Period for Average Pain Score
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo
	Comments	Change from Screening Period value to end of the OL Period for Pain Right Now
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo
	Comments	Change from Screening Period value to end of the OL Period for Pain Severity Index
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo
	Comments	Change from Screening Period value to end of the OL Period for Pain Interference Index
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments

9. Secondary Outcome

Title	Change From Screening Period to Randomization Baseline in BPI-sf: Worst Pain, Least Pain, Average Pain, Pain Right Now, Pain Severity Index, Pain Interference Index
Description	BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. Pain Severity Index is the mean of the 4 pain scores (worst, least, average, and right now) on the BPI-sf; range is 0=No pain to 10=Pain as bad as you can imagine; A higher score indicates greater pain severity. Pain Interference Index is the mean of the scores for the 7 items of the BPI-sf; range is 0=Does not interfere to 10=Completely interferes.
Time Frame	Screening, Randomization Baseline

Outcome Measure Data

Analysis Population Description

ITT Population - observed cases; n=number of participants assessed for the given parameter at the specified timepoint.

Arm/Group Title	Open ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
Measure Participants	279
Worst Pain Score (n=279)	-4.2 (1.83)
Least Pain Score (n=279)	-3.4 (2.04)
Average Pain Score (n=279)	-3.8 (1.60)
Pain Right Now (n=279)	-4.2 (1.95)
Pain Severity Index (n=279)	-3.9 (1.63)
Pain Interference Index (n=279)	-3.4 (2.16)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo
	Comments	Change from Screening Period value to Randomization Baseline for Worst Pain Score
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo
	Comments	Change from Screening Period value to Randomization Baseline for Least Pain Score
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo
	Comments	Change from Screening Period value to Randomization Baseline for Average Pain Score
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo
	Comments	Change from Screening Period value to Randomization Baseline for Pain Right Now
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo
	Comments	Change from Screening Period value to Randomization Baseline for Pain Severity Index
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo
	Comments	Change from Screening Period value to Randomization Baseline for Pain Interference Index
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments

10. Secondary Outcome

Title	Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Worst Pain
Description	BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.
Time Frame	Weeks 2, 4, 8, and 12

Outcome Measure Data

Analysis Population Description

ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for worst pain at the specified timepoint.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	134	146
Week 2 (n=126,135)	1.00 (0.160)	0.38 (0.155)
Week 4 (n=111,125)	1.15 (0.179)	0.51 (0.168)
Week 8 (n=89,113)	0.86 (0.205)	0.49 (0.180)
Week 12/Early Termination (ET)(n=131,138)	1.45 (0.176)	0.47 (0.170)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Randomization Baseline to Week 2.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0056
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.62
	Confidence Interval	(2-Sided) 95%; -1.06 to -0.18
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.222
	Estimation Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Randomization Baseline to Week 4.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0090
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.64
	Confidence Interval	(2-Sided) 95%; -1.12 to -0.16
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.243
	Estimation Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Randomization Baseline to Week 8.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1684
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.37
	Confidence Interval	(2-Sided) 95%; -0.91 to 0.16
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.271
	Estimation Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Randomization Baseline to Week 12/Early Termination.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.98
	Confidence Interval	(2-Sided) 95%; -1.46 to -0.50
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.244
	Estimation Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.

11. Secondary Outcome

Title	Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Least Pain
Description	BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.
Time Frame	Weeks 2, 4, 8, and 12

Outcome Measure Data

Analysis Population Description

ITT Population - imputed values at early termination. Imputation by LOCF; n=number of participants assessed for least pain at the specified timepoint.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	134	146
Week 2 (n=126,135)	0.74 (0.139)	0.34 (0.134)
Week 4 (n=111,125)	0.94 (0.147)	0.06 (0.138)
Week 8 (n=89,112)	0.83 (0.171)	0.19 (0.151)
Week 12/ET(n=131,138)	1.13 (0.151)	0.28 (0.147)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Randomization Baseline to Week 2
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0412
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.40
	Confidence Interval	(2-Sided) 95%; -0.78 to -0.02
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.193
	Estimation Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Randomization Baseline to Week 4
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.87
	Confidence Interval	(2-Sided) 95%; -1.27 to -0.48
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.201
	Estimation Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Randomization Baseline to Week 8.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0055
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.64
	Confidence Interval	(2-Sided) 95%; -1.08 to -0.19
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.226
	Estimation Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Randomization Baseline to Week 12/Early Termination.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.86
	Confidence Interval	(2-Sided) 95%; -1.27 to -0.44
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.210
	Estimation Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.

12. Secondary Outcome

Title	Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Average Pain
Description	BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.
Time Frame	Weeks 2, 4, 8, and 12

Outcome Measure Data

Analysis Population Description

ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for average pain at the specified timepoint.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	134	146
Week 2 (n=125,135)	1.01 (0.137)	0.36 (0.132)
Week 4 (n=111,124)	1.04 (0.156)	0.30 (0.147)
Week 8 (n=88,112)	0.99 (0.179)	0.35 (0.157)
Week 12/ET (n=131,138)	1.27 (0.159)	0.39 (0.154)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Randomization Baseline to Week 2.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0007
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.65
	Confidence Interval	(2-Sided) 95%; -1.02 to -0.27
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.190
	Estimation Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Randomization Baseline to Week 4.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0006
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.74
	Confidence Interval	(2-Sided) 95%; -1.16 to -0.32
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.213
	Estimation Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Randomization Baseline to Week 8.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0070
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.64
	Confidence Interval	(2-Sided) 95%; -1.11 to -0.18
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.236
	Estimation Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Randomization Baseline to Week 12/Early Termination.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.88
	Confidence Interval	(2-Sided) 95%; -1.31 to -0.44
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.221
	Estimation Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.

13. Secondary Outcome

Title	Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Right Now
Description	BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.
Time Frame	Weeks 2, 4, 8, and 12

Outcome Measure Data

Analysis Population Description

ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for pain right now at the specified timepoint.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	134	146
Week 2 (n=126,135)	1.04 (0.149)	0.40 (0.144)
Week 4 (n=111,125)	1.03 (0.157)	0.24 (0.148)
Week 8 (n=88,112)	1.04 (0.200)	0.33 (0.176)
Week 12/ET (n=131,138)	1.43 (0.166)	0.36 (0.161)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Randomization Baseline to Week 2.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0022
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.64
	Confidence Interval	(2-Sided) 95%; -1.05 to -0.23
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.207
	Estimation Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Randomization Baseline to Week 4.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0003
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.79
	Confidence Interval	(2-Sided) 95%; -1.21 to -0.37
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.214
	Estimation Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Randomization Baseline to Week 8.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0078
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.71
	Confidence Interval	(2-Sided) 95%; -1.23 to -0.19
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.264
	Estimation Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Randomization Baseline to Week 12/Early Termination.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-1.07
	Confidence Interval	(2-Sided) 95%; -1.52 to -0.62
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.231
	Estimation Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.

14. Secondary Outcome

Title	Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Severity Index
Description	Pain Severity Index is the mean of the 4 pain scores (worst, least, average, and right now) on the BPI-sf; range is 0=No pain to 10=Pain as bad as you can imagine; a higher score indicates greater pain severity.
Time Frame	Weeks 2, 4, 8, and 12

Outcome Measure Data

Analysis Population Description

ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for pain severity index at the specified timepoint.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	134	146
Week 2 (n=125,135)	0.95 (0.136)	0.37 (0.131)
Week 4 (n=111,124)	1.04 (0.145)	0.28 (0.137)
Week 8 (n=88,112)	0.95 (0.173)	0.34 (0.152)
Week 12/ET (n=131,138)	1.32 (0.149)	0.38 (0.144)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Randomization Baseline to Week 2.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0022
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.58
	Confidence Interval	(2-Sided) 95%; -0.95 to -0.21
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.189
	Estimation Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Randomization Baseline to Week 4.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0002
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.76
	Confidence Interval	(2-Sided) 95%; -1.15 to -0.37
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.198
	Estimation Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Randomization Baseline to Week 8.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0078
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.61
	Confidence Interval	(2-Sided) 95%; -1.06 to -0.16
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.228
	Estimation Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Randomization Baseline to Week 12/Early Termination.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.95
	Confidence Interval	(2-Sided) 95%; -1.35 to -0.54
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.207
	Estimation Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.

15. Secondary Outcome

Title	Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Interference Index
Description	Pain Interference Index is the mean of the scores for the 7 items of the BPI-sf; range is 0=Does not interfere to 10=Completely interferes.
Time Frame	Weeks 2, 4, 8, and 12

Outcome Measure Data

Analysis Population Description

ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for pain interference index at the specified timepoint.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	134	146
Week 2 (n=126,135)	0.77 (0.135)	0.36 (0.130)
Week 4 (n=111,127)	0.92 (0.139)	0.43 (0.129)
Week 8 (n=89,113)	0.64 (0.168)	0.47 (0.148)
Week 12/ET (n=131,138)	1.14 (0.149)	0.49 (0.145)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Randomization Baseline to Week 2.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0285
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.41
	Confidence Interval	(2-Sided) 95%; -0.78 to -0.04
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.188
	Estimation Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Randomization Baseline to Week 4.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0106
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.48
	Confidence Interval	(2-Sided) 95%; -0.85 to -0.11
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.188
	Estimation Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Randomization Baseline to Week 8.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4529
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.17
	Confidence Interval	(2-Sided) 95%; -0.60 to 0.27
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.222
	Estimation Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Randomization Baseline to Week 12/Early Termination.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0018
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.65
	Confidence Interval	(2-Sided) 95%; -1.06 to -0.25
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.207
	Estimation Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.

16. Secondary Outcome

Title	Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Worst Pain
Description	BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.
Time Frame	Weeks 2, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for worst pain at the specified timepoint.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	134	146
Week 2 (n=126,134)	-3.09 (0.186)	-3.80 (0.181)
Week 4 (n=111,124)	-3.01 (0.203)	-3.74 (0.192)
Week 8 (n=89,112)	-3.16 (0.238)	-3.72 (0.212)
Week 12/ET (n=131,137)	-2.63 (0.207)	-3.73 (0.203)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Screening to Week 2.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0061
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.71
	Confidence Interval	(2-Sided) 95%; -1.22 to -0.20
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.258
	Estimation Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Screening to Week 4.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0087
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.73
	Confidence Interval	(2-Sided) 95%; -1.28 to -0.19
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.277
	Estimation Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Screening to Week 8.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0769
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.56
	Confidence Interval	(2-Sided) 95%; -1.18 to 0.06
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.315
	Estimation Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Screening to Week 12/Early Termination.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0002
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-1.10
	Confidence Interval	(2-Sided) 95%; -1.67 to -0.53
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.289
	Estimation Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.

17. Secondary Outcome

Title	Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Least Pain
Description	BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.
Time Frame	Weeks 2, 4, 8, and 12

Outcome Measure Data

Analysis Population Description

ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for least pain at the specified timepoint.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	134	146
Week 2 (n=126,134)	-2.55 (0.162)	-3.05 (0.157)
Week 4 (n=111,124)	-2.40 (0.171)	-3.29 (0.162)
Week 8 (n=89,111)	-2.44 (0.199)	-3.21 (0.178)
Week 12/ET (n=131,137)	-2.14 (0.175)	-3.12 (0.171)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Screening to Week 2.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0250
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.51
	Confidence Interval	(2-Sided) 95%; -0.95 to -0.06
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.224
	Estimation Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Screening to Week 4.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0002
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.89
	Confidence Interval	(2-Sided) 95%; -1.36 to -0.43
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.234
	Estimation Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Screening to Week 8.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0038
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.77
	Confidence Interval	(2-Sided) 95%; -1.29 to -0.25
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.263
	Estimation Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Screening to Week 12/Early Termination.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.98
	Confidence Interval	(2-Sided) 95%; -1.46 to -0.50
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.243
	Estimation Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.

18. Secondary Outcome

Title	Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Average Pain
Description	BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; higher scores indicate greater pain.
Time Frame	Weeks 2, 4, 8, and 12

Outcome Measure Data

Analysis Population Description

ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for average pain at the specified timepoint.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	134	146
Week 2 (n=125,134)	-2.63 (0.154)	-3.43 (0.150)
Week 4 (n=111,123)	-2.76 (0.172)	-3.55 (0.164)
Week 8 (n=88,111)	-2.71 (0.205)	-3.50 (0.182)
Week 12/ET (n=131,137)	-2.39 (0.176)	-3.43 (0.172)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Screening to Week 2.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0002
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.80
	Confidence Interval	(2-Sided) 95%; -1.22 to -0.38
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.214
	Estimation Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Screening to Week 4.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0010
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.78
	Confidence Interval	(2-Sided) 95%; -1.25 to -0.32
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.235
	Estimation Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Screening to Week 8.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0041
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.79
	Confidence Interval	(2-Sided) 95%; -1.32 to -0.25
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.271
	Estimation Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Screening to Week 12/Early Termination.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-1.04
	Confidence Interval	(2-Sided) 95%; -1.52 to -0.56
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.245
	Estimation Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.

19. Secondary Outcome

Title	Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Right Now
Description	BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; higher scores indicate greater pain.
Time Frame	Weeks 2, 4, 8, and 12

Outcome Measure Data

Analysis Population Description

ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for pain right now at the specified timepoint.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	134	146
Week 2 (n=126,134)	-3.12 (0.170)	-3.72 (0.165)
Week 4 (n=111,124)	-3.15 (0.187)	-3.82 (0.177)
Week 8 (n=88,111)	-3.00 (0.232)	-3.71 (0.206)
Week 12/ET (n=131,137)	-2.72 (0.189)	-3.74 (0.186)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Screening to Week 2.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0115
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.60
	Confidence Interval	(2-Sided) 95%; -1.06 to -0.14
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.236
	Estimation Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Screening to Week 4.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0099
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.66
	Confidence Interval	(2-Sided) 95%; -1.17 to -0.16
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.256
	Estimation Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Screening to Week 8.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0222
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.71
	Confidence Interval	(2-Sided) 95%; -1.31 to -0.10
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.307
	Estimation Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Screening to Week 12/ Early Termination.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-1.02
	Confidence Interval	(2-Sided) 95%; -1.54 to -0.50
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.264
	Estimation Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.

20. Secondary Outcome

Title	Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Severity Index
Description	Pain Severity Index is the mean of the 4 pain scores (worst, least, average, and right now) on the BPI-sf; range is 0=No pain to 10=Pain as bad as you can imagine; a higher score indicates greater pain severity.
Time Frame	Weeks 2, 4, 8, and 12

Outcome Measure Data

Analysis Population Description

ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for pain severity index at the specified timepoint.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	134	146
Week 2 (n=125,134)	-2.83 (0.157)	-3.50 (0.152)
Week 4 (n=111,123)	-2.83 (0.172)	-3.60 (0.164)
Week 8 (n=88,111)	-2.80 (0.205)	-3.53 (0.182)
Week 12/ET (n=131,137)	-2.47 (0.174)	-3.51 (0.171)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Screening to Week 2.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0025
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.66
	Confidence Interval	(2-Sided) 95%; -1.09 to -0.24
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.218
	Estimation Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Screening to Week 4.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0012
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.77
	Confidence Interval	(2-Sided) 95%; -1.23 to -0.31
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.235
	Estimation Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Screening to Week 8.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0078
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.73
	Confidence Interval	(2-Sided) 95%; -1.27 to -0.19
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.272
	Estimation Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Screening to Week 12/Early Termination.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-1.04
	Confidence Interval	(2-Sided) 95%; -1.52 to -0.56
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.243
	Estimation Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.

21. Secondary Outcome

Title	Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Interference Index
Description	Pain Interference Index is the mean of the scores for the 7 items of the BPI-sf; range is 0=Does not interfere to 10=Completely interferes.
Time Frame	Weeks 2, 4, 8, and 12

Outcome Measure Data

Analysis Population Description

ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for pain interference index at the specified timepoint.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	134	146
Week 2 (n=126,134)	-2.58 (0.164)	-2.99 (0.160)
Week 4 (n=111,126)	-2.52 (0.175)	-2.99 (0.164)
Week 8 (n=89,112)	-2.72 (0.198)	-2.87 (0.176)
Week 12/ET (n=131,137)	-2.24 (0.176)	-2.88 (0.172)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Screening to Week 2.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0727
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.41
	Confidence Interval	(2-Sided) 95%; -0.86 to 0.04
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.228
	Estimation Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Screening to Week 4.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0501
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.47
	Confidence Interval	(2-Sided) 95%; -0.94 to 0.00
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.238
	Estimation Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Screening to Week 8.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.5704
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.15
	Confidence Interval	(2-Sided) 95%; -0.67 to 0.37
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.262
	Estimation Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Screening to Week 12/ Early Termination.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0096
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.64
	Confidence Interval	(2-Sided) 95%; -1.12 to -0.16
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.245
	Estimation Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.

22. Secondary Outcome

Title	Area Under the Curve (AUC) of eDiary NRS-Pain Scores From Randomization Baseline to Final 2 Weeks of the Double-Blind Treatment Period (Weeks 11 and 12)
Description	NRS-Pain scores based on an 11-point numerical rating scale from 0 (no pain) to 10 (worst possible pain). AUC was calculated using daily change from Baseline scores from Baseline until the last dose date in the Double-Blind Treatment Period. AUC was calculated for each participant using the linear trapezoidal method. Higher scores indicate greater pain.
Time Frame	Randomization Baseline, Weeks 11 and 12

Outcome Measure Data

Analysis Population Description

ITT Population; linear interpolation was used for internal missing values, with addition of 0 to the AUC for missing values from early discontinuation.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	134	146
Least Squares Mean (Standard Error) [Change in units on a scale*days]	39.00 (7.914)	11.25 (7.636)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0120
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-27.75
	Confidence Interval	(2-Sided) 95%; -49.34 to -6.16
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 10.968
	Estimation Comments	Difference between treatment groups evaluated by ANCOVA with treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.

23. Secondary Outcome

Title	Average Daily Use of Rescue Acetaminophen (Milligrams Per Day [mg/Day]) During the Double-Blind Treatment Period
Description	The amount of acetaminophen administered for each treatment during the Double-Blind Treatment Period. Average daily use calculated as: total dose of rescue medication during Double-Blind Period divided by the number of days in Double-Blind Period.
Time Frame	Daily from Day 1 of the Double-Blind Period through Week 12

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	134	146
Least Squares Mean (Standard Error) [Average mg/day]	207.84 (36.436)	203.97 (34.851)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9390
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-3.87
	Confidence Interval	(2-Sided) 95%; -103.29 to 95.55
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 50.500
	Estimation Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the average daily rescue acetaminophen during the Titration Period and final total daily study medication dose of the Titration Period as covariates.

24. Secondary Outcome

Title	Percentage of Participants With a 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to End of Open-Label Treatment
Description	The percentage of analgesic response is defined as: (rolling 7-day mean pain score during Titration Period - Screening Period pain intensity score) divided by Screening Period pain intensity score times100.
Time Frame	Screening, Week 4, 5 or 6

Outcome Measure Data

Analysis Population Description

Titration Period Safety Population; an event was defined as a participant with 20%, 30%, 40%, or 50% analgesic response from Screening.

Arm/Group Title	Open ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
Measure Participants	398
Participants with 20% Analgesic Response	85.2 20.8%
Participants with 30% Analgesic Response	78.9 19.2%
Participants with 40% Analgesic Response	67.3 16.4%
Participants with 50% Analgesic Response	49.7 12.1%

25. Secondary Outcome

Title	Median Time to 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to End of Open-Label Treatment
Description	The percentage of analgesic response is defined as: (rolling 7-day mean pain score during Titration Period minus (-) Screening Period pain intensity score) divided by Screening Period pain intensity score times 100. An event was defined as a participant with 20, 30, 40, or 50% analgesic response from Screening. If there was no event for a participant, time to the event was considered censored at Day 42 of the Titration Period or before Day 42 of the Titration Period at the time of the last diary pain score. The survival duration begins on the date of first dose of study drug in the Titration Period and is calculated as the [date of event or last diary pain score - date of first dose in Titration Period +1].
Time Frame	Screening, Week 4, 5, or 6

Outcome Measure Data

Analysis Population Description

Titration Period Safety Population; an event was defined as a participant with 20%, 30%, 40%, or 50% analgesic response from Screening.

Arm/Group Title	Open ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
Measure Participants	398
Time to 20% Analgesic Response from Screening	15
Time to 30% Analgesic Response from Screening	21
Time to 40% Analgesic Response from Screening	28
Time to 50% Analgesic Response from Screening	35

26. Secondary Outcome

Title	Percentage of Participants With a 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to Randomization Baseline
Description	The percentage of analgesic response is defined as: (rolling 7-day mean pain score during Titration Period - Screening Period pain intensity score) divided by Screening Period pain intensity score times 100.
Time Frame	Screening, Randomization Baseline (up to 6 weeks)

Outcome Measure Data

Analysis Population Description

ITT Population; an event was defined as a participant with 20%, 30%, 40%, or 50% analgesic response from Screening.

Arm/Group Title	Open ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
Measure Participants	278
Participants with 20% Analgesic Response	99.3 24.2%
Participants with 30% Analgesic Response	95.3 23.2%
Participants with 40% Analgesic Response	86.0 21%
Participants with 50% Analgesic Response	64.0 15.6%

27. Secondary Outcome

Title	Median Time to 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to Randomization Baseline
Description	The percentage of analgesic response is defined as: (rolling 7-day mean pain score during Titration Period - Screening Period pain intensity score) divided by Screening Period pain intensity score times 100. If there was no event for a participant, time to the event was considered censored at Day 42 of the Titration Period or before Day 42 of the Titration Period at the time of the last diary pain score. The survival duration begins on the date of first dose of study drug in the Titration Period and is calculated as the [date of event or last diary pain score - date of first dose in Titration Period +1].
Time Frame	Screening, Randomization Baseline (up to 6 weeks)

Outcome Measure Data

Analysis Population Description

ITT Population; an event was defined as a participant with 20%, 30%, 40% or 50% analgesic response from Screening.

Arm/Group Title	Open ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
Measure Participants	278
Time to 20% Analgesic Response	14
Time to 30% Analgesic Response	20
Time to 40% Analgesic Response	26
Time to 50% Analgesic Response	33

28. Secondary Outcome

Title	Percentage of Participants With a 20%, 30%, 40%, or 50% Loss of Analgesic Response From Randomization Baseline During the Double-Blind Treatment Period
Description	The percentage of lost analgesic response is defined as: (rolling 7-day mean pain score during Double-Blind Period - Randomization Baseline pain intensity score) divided by Randomization Baseline pain intensity score times 100. If there was no event for a participant, time to the event was considered censored at Day 84 or before Day 84 at the time of the last diary pain score. The survival duration began on the date of first dose of study drug in the Double-Blind Period and was calculated as the [date of event or last diary pain score - date of first dose in Double-Blind Treatment +1].
Time Frame	Randomization Baseline, up to Week 12

Outcome Measure Data

Analysis Population Description

ITT Population; an event was defined as a participant with 20%, 30%, 40%, or 50% loss of analgesic response from Randomization Baseline.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	132	143
Participants with 20% Loss of Analgesic Response	72.0 17.6%	54.5 NaN
Participants with 30% Loss of Analgesic Response	64.4 15.7%	46.2 NaN
Participants with 40% Loss of Analgesic Response	57.6 14%	34.3 NaN
Participants with 50% Loss of Analgesic Response	50.8 12.4%	31.5 NaN

29. Secondary Outcome

Title	Median Time to 20%, 30%, 40%, or 50% Loss of Analgesic Response From Baseline During the Double-Blind Treatment Period
Description	The percentage of lost analgesic response was defined as: (rolling seven day mean pain score during Double-Blind Period - Randomization Baseline pain intensity score) divided by Randomization Baseline pain intensity score times 100. If there was no event for a participant, time to the event was considered censored at Day 84 or before Day 84 at the time of the last diary pain score. The survival duration began on the date of first dose of study drug in the Double-Blind Period and was calculated as the [date of event or last diary pain score - date of first dose in Double-Blind Treatment +1].
Time Frame	Randomization Baseline, up to Week 12

Outcome Measure Data

Analysis Population Description

ITT Population; an event was defined as a participant with 20%, 30%, 40%, or 50% loss of analgesic response from Randomization Baseline.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	132	143
Time to 20% Loss of Analgesic Response	12	31
Time to 30% Loss of Analgesic Response	21	NA
Time to 40% Loss of Analgesic Response	41	NA
Time to 50% Loss of Analgesic Response	62	NA

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Time to 20% loss of analgesic response
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0014
	Comments
	Method	Wilcoxon test, survival analysis
	Comments	P-value from Wilcoxon test with treatment and opioid stratum as factors

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Time to 30% loss of analgesic response.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0024
	Comments
	Method	Wilcoxon test, survival analysis
	Comments	P-value from Wilcoxon test with treatment and opioid stratum as factors

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Time to 40% loss of analgesic response.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0006
	Comments
	Method	Wilcoxon test, survival analysis
	Comments	P-value from Wilcoxon test with treatment and opioid stratum as factors

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Time to 50% loss of analgesic response
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0021
	Comments
	Method	Wilcoxon test, survival analysis
	Comments	P-value from Wilcoxon test with treatment and opioid stratum as factors

30. Secondary Outcome

Title	Percentage of Participants Discontinuing Treatment for Investigator-Reported Lack of Efficacy
Description	If there was no event for a participant, time to the event was considered censored at Day 84 or before Day 84 at time of treatment discontinuation for another reason.
Time Frame	Week 1 up to Week 12

Outcome Measure Data

Analysis Population Description

ITT Population; an event was defined as a participant with treatment discontinuation for investigator-reported lack of efficacy.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	134	146
Number [Percentage of participants]	11.9 2.9%	2.7 NaN

31. Secondary Outcome

Title	Median Time to Treatment Discontinuation for Investigator-Reported Lack of Efficacy During the Double-Blind Treatment Period
Description	If there was no event for a participant, time to the event was considered censored at Day 84 or before Day 84 at time of treatment discontinuation for another reason. The survival duration begins on the date of first dose in the Double-Blind period and is calculated as the [date of event or discontinuation - date of first dose in Double-Blind Period +1].
Time Frame	Week 1 up to Week 12

Outcome Measure Data

Analysis Population Description

ITT Population; an event was defined as a participant with treatment discontinuation for investigator-reported lack of efficacy.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	134	146
Median (95% Confidence Interval) [days]	NA	NA

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.006
	Comments
	Method	Wilcoxon test, survival analysis
	Comments	P-value from Wilcoxon test with treatment and opioid stratum as factors.

32. Secondary Outcome

Title	Clinical Opiate Withdrawal Scale (COWS) Total Score During the Open-Label Titration Period
Description	The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. Higher scores indicate a worse outcome. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal.
Time Frame	Screening, Weeks 1, 2, 3, 4, 5, and 6

Outcome Measure Data

Analysis Population Description

Titration Period Safety Population. Only participants with values at both Screening and each respective visit were included in the change from screening analysis; n=number of participants analyzed for the given parameter at the specified timepoint.

Arm/Group Title	Open ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
Measure Participants	410
Screening (n=387)	0.6 (1.09)
Week 1 (n=353)	0.6 (1.04)
Change from Screening at Week 1 (n=333)	0.0 (1.20)
Week 2 (n=327)	0.5 (1.08)
Change from Screening at Week 2 (n=308)	0.0 (1.25)
Week 3 (n=316)	0.5 (0.92)
Change from Screening at Week 3 (n=295)	-0.1 (1.21)
Week 4 (n=210)	0.6 (0.94)
Change from Screening at Week 4 (n=194)	0.0 (1.27)
Week 5 (n=138)	0.6 (0.82)
Change from Screening at Week 5 (n=131)	-0.1 (1.15)
Week 6/ET (n=375)	0.6 (0.99)
Change from Screening at Week 6 (n=352)	0.0 (1.28)
Maximum Titration Period (MTP) Value (n=375)	1.2 (1.42)
Change from screening to MTP Value (n=352)	0.6 (1.54)

33. Secondary Outcome

Title	COWS Total Score During the Double-Blind Treatment Period
Description	The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. Higher scores indicate a worse outcome. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal.
Time Frame	Randomization Baseline, Weeks 1, 2, 4, 8, and 12

Outcome Measure Data

Analysis Population Description

Double-Blind Safety Population. Only participants with values at both Randomization Baseline and each respective visit were included in the change from Randomization Baseline analysis; n=number of participants analyzed for the given parameter at the specified timepoint.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	134	146
Randomization Baseline (n=134,146)	0.6 (0.85)	0.4 (0.73)
Week 1 (n=111,133)	0.8 (1.62)	0.6 (1.13)
Change from Baseline at Week 1 (n=111,133)	0.3 (1.69)	0.3 (1.12)
Week 2 (n=115,128)	0.8 (1.28)	0.7 (1.19)
Change from Baseline at Week 2 (n=115,128)	0.2 (1.45)	0.3 (1.10)
Week 4 (n=106,123)	0.6 (0.90)	0.4 (0.66)
Change from Baseline at Week 4 (n=106,123)	0.1 (1.10)	0.1 (0.79)
Week 8 (n=87,107)	0.6 (1.02)	0.6 (1.10)
Change from Baseline at Week 8 (n=87,107)	0.1 (1.03)	0.2 (1.06)
Week 12/ET (n=126,140)	0.7 (1.55)	0.6 (1.17)
Change from Baseline at Week 12/ET(n=126,140)	0.2 (1.61)	0.2 (1.21)
Max. Double-Blind Period (DBP) Value (n=126,140)	1.4 (1.84)	1.3 (1.60)
Change from Baseline to max. DBP Value (n=126,140)	0.9 (1.90)	0.9 (1.53)

34. Secondary Outcome

Title	COWS Total Score During the Post-Treatment Period
Description	The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. Higher scores indicate a worse outcome. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal.
Time Frame	Follow-Up (FU) Weeks 1 and 2

Outcome Measure Data

Analysis Population Description

Double-Blind Safety Population. Only participants with values at both Randomization Baseline and each respective visit were included in the change from Randomization Baseline analysis; n=number of participants analyzed for the given parameter at the specified timepoint.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	94	108
FU Week 1 (n=68,83)	0.6 (0.72)	0.6 (0.91)
Change from Baseline at FU Week 1 (n=68,83)	0.1 (0.90)	0.2 (0.99)
FU Week 2 (n=78,91)	0.5 (0.70)	0.9 (1.74)
Change from Baseline at FU Week 2 (n=78,91)	-0.1 (1.12)	0.7 (1.83)
Max.FU Period Value (n=94,108)	0.7 (0.76)	1.1 (1.67)
Change to max. FU Period Value (n=94,108)	0.1 (1.08)	0.7 (1.74)

35. Secondary Outcome

Title	Percentage of Participants With Opiate Withdrawal During the Open-Label Titration Period by COWS Category
Description	The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal. The scores are assessed as follows: 5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal.
Time Frame	Screening, Weeks 1, 2, 3, 4, 5, 6 (or Early Termination)

Outcome Measure Data

Analysis Population Description

Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.

Arm/Group Title	Open ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
Measure Participants	410
Screening COWS less than(<)5 (n=387)	98.4 24%
Screening COWS=5-12 (n=387)	1.6 0.4%
Week 1 COWS <5 (n=353)	99.2 24.2%
Week 1 COWS=5-12 (n=353)	0.8 0.2%
Week 2 COWS <5 (n=327)	98.8 24.1%
Week 2 COWS 5-12 (n=327)	1.2 0.3%
Week 3 COWS <5 (n=316)	99.1 24.2%
Week 3 COWS 5-12 (n=316)	0.9 0.2%
Week 4 COWS <5 (n=210)	99.5 24.3%
Week 4 COWS 5-12 (n=210)	0.5 0.1%
Week 5 COWS <5 (n=138)	100 24.4%
Week 6 COWS <5 (n=375)	98.9 24.1%
Week 6 COWS 5-12 (n=375)	1.1 0.3%
Max. Titration Period Value COWS <5 (n=375)	96.8 23.6%
Max. Titration Period Value COWS 5-12 (n=375)	3.2 0.8%

36. Secondary Outcome

Title	Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category
Description	The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal. The scores are assessed as follows: 5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal.
Time Frame	Randomization Baseline, Weeks 1, 2, 4, 8, 12 (or Early Termination)

Outcome Measure Data

Analysis Population Description

Double-Blind Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	134	146
Randomization Baseline COWS <5 (n=134,146)	100 24.4%	100 NaN
Week 1 COWS <5 (n=111,133)	99.1 24.2%	98.5 NaN
Week 1 COWS 5-12 (n=111,133)	0 0%	1.5 NaN
Week 1 COWS 13-24 (n=111,133)	0.9 0.2%	0 NaN
Week 2 COWS <5 (n=115,128)	99.1 24.2%	98.4 NaN
Week 2 COWS 5-12 (n=115,128)	0.9 0.2%	1.6 NaN
Week 4 COWS <5 (n=106,123)	99.1 24.2%	100 NaN
Week 4 COWS 5-12 (n=106,123)	0.9 0.2%	0 NaN
Week 8 COWS <5 (n=87,107)	100 24.4%	98.1 NaN
Week 8 COWS 5-12 (n=87,107)	0 0%	1.9 NaN
Week 12/ET COWS <5 (n=126,140)	98.4 24%	97.9 NaN
Week 12/ET COWS 5-12 (n=126,140)	0.8 0.2%	2.1 NaN
Week 12/ET COWS 13-24 (n=126,140)	0.8 0.2%	0 NaN
Max. DBP Value COWS <5 (n=126,140)	97.6 23.8%	95.0 NaN
Max. DBP Value COWS 5-12 (n=126,140)	1.6 0.4%	5.0 NaN
Max. DBP Value COWS 13-24 (n=126,140)	0.8 0.2%	0 NaN

37. Secondary Outcome

Title	Percentage of Participants With Opiate Withdrawal During Post-Treatment by COWS Category
Description	The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal. The scores are assessed as follows: 5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal.
Time Frame	Follow-Up Weeks 1 and 2

Outcome Measure Data

Analysis Population Description

Double-Blind Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	94	108
FU Week 1 COWS <5 (n=68,83)	100.0 24.4%	100.0 NaN
FU Week 2 COWS <5 (n=78,91)	100 24.4%	95.6 NaN
FU Week 2 COWS=5-12 (n=78,91)	0 0%	4.4 NaN
Maximum FU Period COWS <5 (n=94,108)	100.0 24.4%	96.3 NaN
Maximum FU Period COWS=5-12 (n=94,108)	0 0%	3.7 NaN

38. Secondary Outcome

Title	Subjective Opiate Withdrawal Scale (SOWS) During the Open-Label Titration Period
Description	The SOWS was completed daily by the participant during any of the 2-week tapers from study drug, as well as at each study visit, using an eDiary device, and contains 16 symptoms of opiate withdrawal rated by the participant (Scale of 0 to 4: 0 = not at all, 1 = a little, 2= moderately, 3= quite a bit, 4 = extremely). The sum of the scores on each item was the total SOWS score; the minimum possible SOWS score was 0, the maximum 64. Higher scores indicate a worse outcome.
Time Frame	Screening, Weeks 1, 2, 3, 4, 5, and 6

Outcome Measure Data

Analysis Population Description

Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.

Arm/Group Title	Open ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
Measure Participants	410
Screening (n=395)	4.1 (4.92)
Week 1 (n=355)	3.5 (4.31)
Change from Screening at Week 1 (n=346)	-0.7 (4.71)
Week 2 (n=329)	3.0 (3.66)
Change from Screening at Week 2 (n=320)	-1.2 (4.64)
Week 3 (n=311)	2.7 (4.17)
Change from Screening at Week 3 (n=304)	-1.4 (5.24)
Week 4 (n=206)	2.2 (2.92)
Change from Screening at Week 4 (n=199)	-2.1 (4.92)
Week 5 (n=139)	2.2 (2.96)
Change from Screening at Week 5 (n=133)	-2.4 (4.42)
Week 6/ET (n=369)	3.0 (4.41)
Change from Screening at Week 6/ET (n=359)	-1.2 (5.36)
Max. SOWS (Titration Period) (n=369)	4.9 (5.35)
Change from Screening at Max. SOWS (n=359)	0.7 (5.51)

39. Secondary Outcome

Title	SOWS Total Score During the Double-Blind Treatment Period
Description	The SOWS was completed daily by the participant during any of the 2-week tapers from study drug, as well as at each study visit, using an eDiary device, and contains 16 symptoms of opiate withdrawal rated by the participant (Scale of 0 to 4: 0 = not at all, 1 = a little, 2= moderately, 3= quite a bit, 4 = extremely). The sum of the scores on each item was the total SOWS score; the minimum possible SOWS score was 0, the maximum 64. Higher scores indicate a worse outcome.
Time Frame	Randomization Baseline, Weeks 1, 2, 4, 8, and 12

Outcome Measure Data

Analysis Population Description

Double-Blind Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	134	146
Randomization Baseline (n=134,146)	2.4 (3.88)	1.5 (2.20)
Week 1 (n=134,143)	3.0 (4.27)	2.3 (3.69)
Change from Baseline at Week 1 (n=134,143)	0.6 (4.08)	0.8 (2.93)
Week 2 (n=123,135)	3.5 (6.56)	1.9 (3.11)
Change from Baseline at Week 2 (n=123,135)	1.1 (5.37)	0.3 (2.64)
Max. SOWS, First 2 Weeks of Period (n=134,143)	6.3 (7.72)	4.4 (5.11)
Week 4 (n=105,122)	2.5 (3.91)	2.1 (3.42)
Change from Baseline at Week 4 (n=105,122)	0.1 (3.57)	0.5 (2.39)
Week 8 (n=85,110)	2.4 (4.48)	2.1 (3.37)
Change from Baseline at Week 8 (n=85,110)	0.1 (3.83)	0.6 (2.92)
Week 12 (n=134,143)	3.3 (5.70)	2.4 (3.85)
Change from Baseline at Week 12 (n=134,143)	0.9 (5.11)	0.9 (3.01)
Max. SOWS (Double-Blind Period) (n=134,143)	6.7 (7.77)	5.2 (5.89)
Change from Baseline at max. SOWs (n=134,143)	4.3 (5.82)	3.7 (5.14)

40. Secondary Outcome

Title	SOWS Total Score During the Post-Treatment Period
Description	The SOWS was completed daily by the participant during any of the 2-week tapers from study drug, as well as at each study visit, using an eDiary device, and contains 16 symptoms of opiate withdrawal rated by the participant (Scale of 0 to 4: 0 = not at all, 1 = a little, 2= moderately, 3= quite a bit, 4 = extremely). The sum of the scores on each item was the total SOWS score; the minimum possible SOWS score was 0, the maximum 64. Higher scores indicate a worse outcome.
Time Frame	Follow-Up Weeks 1 and 2

Outcome Measure Data

Analysis Population Description

Double-Blind Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	96	110
FU Week 1 (n=94,108)	2.6 (4.91)	2.3 (3.69)
Change from Baseline at FU Week 1 (n=94,108)	0.2 (4.12)	0.8 (3.21)
FU Week 2 (n=95,109)	2.7 (5.26)	2.5 (3.67)
Change from Baseline at FU Week 2 (n=95,109)	0.2 (4.49)	1.0 (3.35)
Max. SOWS (FU Period)(n=96,110)	4.7 (6.73)	4.5 (5.45)
Change from Baseline at Max. SOWS, (n=96,110)	2.2 (5.31)	3.0 (4.77)

41. Secondary Outcome

Title	Change From Screening Period to End of Open-Label Titration Period in Roland-Morris Disability Questionnaire (RMDQ) Total Score for All Participants
Description	RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain the same day the questionnaire is completed. An individual participant's score could have ranged from 0 (no disability) to 24 (severe disability), with a lower score indicating better function; higher scores indicating greater disability.
Time Frame	Screening, Week 6 (or Early Termination)

Outcome Measure Data

Analysis Population Description

Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.

Arm/Group Title	Open ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
Measure Participants	410
Screening (n=405)	12.7 (5.42)
End of Open-Label Titration Period (n=345)	9.0 (5.62)
Change from Screening (n=343)	-3.9 (4.91)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo
	Comments	Change from Screening Period value to the End of Open-Label Titration Period.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments

42. Secondary Outcome

Title	Change From Screening Period to Randomization Baseline in RMDQ Total Score
Description	RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain the same day the questionnaire is completed. An individual participant's score could have ranged from 0 (no disability) to 24 (severe disability), with a lower score indicating better function.
Time Frame	Screening, Randomization Baseline

Outcome Measure Data

Analysis Population Description

ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.

Arm/Group Title	Open ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
Measure Participants	280
Screening (n=277)	12.8 (5.22)
Randomization Baseline (n=256)	7.9 (5.14)
Change from Screening (n=255)	-4.8 (4.95)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo
	Comments	Change from Screening Period value to Randomization Baseline.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments

43. Secondary Outcome

Title	Change From Screening Period to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in RMDQ Total Score
Description	RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain the same day the questionnaire is completed. An individual participant's score could have ranged from 0 (no disability) to 24 (severe disability), with a lower score indicating better function.
Time Frame	Screening, Weeks 2, 4, 8, and 12

Outcome Measure Data

Analysis Population Description

ITT Population; imputation using the LOCF method for Week 12 only; Weeks 2, 4, 8 included observed cases. n=number of participants analyzed for the given parameter at the specified timepoint.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	134	146
Week 2 (n=114,124)	-3.88 (0.423)	-4.93 (0.406)
Week 4 (n=101,111)	-3.90 (0.467)	-4.60 (0.444)
Week 8 (n=77,95)	-4.50 (0.514)	-3.92 (0.459)
Week 12/ET (n=123,128)	-4.33 (0.440)	-4.26 (0.431)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Model-adjusted Change from Screening to Week 2.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0733
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-1.05
	Confidence Interval	(2-Sided) 95%; -2.20 to 0.10
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.584
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Model-adjusted Change from Screening to Week 4.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2783
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.70
	Confidence Interval	(2-Sided) 95%; -1.96 to 0.57
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.642
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Model-adjusted Change from Screening to Week 8.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.3951
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.58
	Confidence Interval	(2-Sided) 95%; -0.77 to 1.93
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.684
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Model-adjusted Change from Screening to Week 12.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9063
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.07
	Confidence Interval	(2-Sided) 95%; -1.14 to 1.28
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.614
	Estimation Comments

44. Secondary Outcome

Title	Change From Randomization Baseline to the End of Double-Blind Weeks 2, 4, and 8 in RMDQ Total Score
Description	RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain the same day the questionnaire is completed. An individual participant's score could have ranged from 0 (no disability) to 24 (severe disability), with a lower score indicating better function.
Time Frame	Randomization Baseline, Weeks 2, 4, and 8

Outcome Measure Data

Analysis Population Description

ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	134	146
Week 2 (n=111,118)	0.54 (0.334)	-0.19 (0.321)
Week 4 (n=98,107)	1.02 (0.420)	0.32 (0.397)
Week 8 (n=73,93)	-0.01 (0.471)	0.41 (0.408)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Model-adjusted change from Baseline to Week 2.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1139
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.74
	Confidence Interval	(2-Sided) 95%; -1.65 to 0.18
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.463
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Model-adjusted Change from Baseline to Week 4.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2264
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.70
	Confidence Interval	(2-Sided) 95%; -1.84 to 0.44
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.577
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Model-adjusted Change from Baseline to Week 8.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.5074
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.41
	Confidence Interval	(2-Sided) 95%; -0.81 to 1.63
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.619
	Estimation Comments

45. Secondary Outcome

Title	Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor
Description	Represents the score at Screening / score at Randomization Baseline in PGA of low back pain, a global evaluation that utilizes a 5-point Likert scale with a score of: 1 = very good, asymptomatic and no limitation of normal activities; 2 = good, mild symptoms, and no limitation of normal activities; 3 = fair, moderate symptoms and limitation to some normal activities; 4 = poor, severe symptoms and inability to carry out most normal activities; and a score of 5 = very poor; very severe symptoms, which were intolerable and inability to carry out all normal activities.
Time Frame	Screening, Randomization Baseline

Outcome Measure Data

Analysis Population Description

ITT Population; percentage was based on the number of participants who had non-missing values at Randomization Baseline and Screening.

Arm/Group Title	Open ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
Measure Participants	277
Very Good / Very Good	0.4 0.1%
Very Good / Good	2.9 0.7%
Very Good / Fair	9.4 2.3%
Very Good / Poor	2.9 0.7%
Very Good / Very Poor	0.0 0%
Good / Very Good	0.0 0%
Good / Good	5.8 1.4%
Good / Fair	29.2 7.1%
Good / Poor	8.7 2.1%
Good / Very Poor	1.4 0.3%
Fair / Very Good	0.0 0%
Fair / Good	2.5 0.6%
Fair / Fair	22.0 5.4%
Fair / Poor	10.5 2.6%
Fair / Very Poor	1.4 0.3%
Poor / Very Good	0.0 0%
Poor / Good	0.4 0.1%
Poor / Fair	2.2 0.5%
Poor / Poor	0.4 0.1%
Poor / Very Poor	0.0 0%
Very Poor / Very Good	0.0 0%
Very Poor / Good	0.0 0%
Very Poor / Fair	0.0 0%
Very Poor / Poor	0.0 0%
Very Poor / Very Poor	0.0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Bowker's test of symmetry
	Comments

46. Secondary Outcome

Title	Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor
Description	Represents the score at Screening / score at to end of the titration period in PGA of low back pain, a global evaluation that utilizes a 5-point Likert scale with a score of: 1 = very good, asymptomatic and no limitation of normal activities; 2 = good, mild symptoms, and no limitation of normal activities; 3 = fair, moderate symptoms and limitation to some normal activities; 4 = poor, severe symptoms and inability to carry out most normal activities; and a score of 5 = very poor; very severe symptoms, which were intolerable and inability to carry out all normal activities.
Time Frame	Screening, Randomization Baseline, or Early Termination

Outcome Measure Data

Analysis Population Description

Titration Period Safety Population; percentage was based on the number of participants who had non-missing values at Randomization Baseline and Screening.

Arm/Group Title	Open ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
Measure Participants	368
Very Good / Very Good	0.3 0.1%
Very Good / Good	2.7 0.7%
Very Good / Fair	7.6 1.9%
Very Good / Poor	2.2 0.5%
Very Good / Very Poor	0.0 0%
Good / Very Good	0.0 0%
Good / Good	5.4 1.3%
Good / Fair	25.0 6.1%
Good / Poor	7.6 1.9%
Good / Very Poor	1.1 0.3%
Fair / Very Good	0.0 0%
Fair / Good	2.7 0.7%
Fair / Fair	27.2 6.6%
Fair / Poor	10.6 2.6%
Fair / Very Poor	1.4 0.3%
Poor / Very Good	0.0 0%
Poor / Good	0.3 0.1%
Poor / Fair	3.0 0.7%
Poor / Poor	2.2 0.5%
Poor / Very Poor	0.3 0.1%
Very Poor / Very Good	0.0 0%
Very Poor / Good	0.0 0%
Very Poor / Fair	0.0 0%
Very Poor / Poor	0.3 0.1%
Very Poor / Very Poor	0.3 0.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Bowker's test of symmetry
	Comments

47. Secondary Outcome

Title	Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor
Description	Represents the score at Randomization Baseline / score at Week 4 in PGA of low back pain, a global evaluation that utilizes a 5-point Likert scale with a score of: 1 = very good, asymptomatic and no limitation of normal activities; 2 = good, mild symptoms, and no limitation of normal activities; 3 = fair, moderate symptoms and limitation to some normal activities; 4 = poor, severe symptoms and inability to carry out most normal activities; and a score of 5 = very poor; very severe symptoms, which were intolerable and inability to carry out all normal activities.
Time Frame	Randomization Baseline, Week 4

Outcome Measure Data

Analysis Population Description

ITT Population; percentage was based on the number of participants who had non-missing values at Randomization Baseline and Week 4 for each treatment.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	109	126
Very Good / Very Good	7.3 1.8%	8.7 NaN
Very Good / Good	3.7 0.9%	0.8 NaN
Very Good / Fair	0.9 0.2%	0.0 NaN
Very Good / Poor	0.0 0%	0.0 NaN
Very Good / Very Poor	0.0 0%	0.0 NaN
Good / Very Good	5.5 1.3%	6.3 NaN
Good / Good	24.8 6%	27.8 NaN
Good / Fair	7.3 1.8%	13.5 NaN
Good / Poor	0.0 0%	0.0 NaN
Good / Very Poor	0.0 0%	0.0 NaN
Fair / Very Good	0.9 0.2%	1.6 NaN
Fair / Good	15.6 3.8%	15.1 NaN
Fair / Fair	24.8 6%	23.0 NaN
Fair / Poor	1.8 0.4%	2.4 NaN
Fair / Very Poor	0.0 0%	0.0 NaN
Poor / Very Good	0.9 0.2%	0.0 NaN
Poor / Good	2.8 0.7%	0.0 NaN
Poor / Fair	2.8 0.7%	0.0 NaN
Poor / Poor	0.0 0%	0.8 NaN
Poor / Very Poor	0.0 0%	0.0 NaN
Very Poor / Very Good	0.0 0%	0.0 NaN
Very Poor / Good	0.0 0%	0.0 NaN
Very Poor / Fair	0.0 0%	0.0 NaN
Very Poor / Poor	0.9 0.2%	0.0 NaN
Very Poor / Very Poor	0.0 0%	0.0 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2211
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Stratified by opioid stratum.

48. Secondary Outcome

Title	Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor
Description	Represents the score at Randomization Baseline / score at Week 8 in PGA of low back pain, a global evaluation that utilizes a 5-point Likert scale with a score of: 1 = very good, asymptomatic and no limitation of normal activities; 2 = good, mild symptoms, and no limitation of normal activities; 3 = fair, moderate symptoms and limitation to some normal activities; 4 = poor, severe symptoms and inability to carry out most normal activities; and a score of 5 = very poor; very severe symptoms, which were intolerable and inability to carry out all normal activities.
Time Frame	Randomization Baseline, Week 8

Outcome Measure Data

Analysis Population Description

ITT Population; percentage was based on the number of participants who had non-missing values at Randomization Baseline and Week 8 for each treatment.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	88	112
Very Good / Very Good	8.0 2%	8.9 NaN
Very Good / Good	5.7 1.4%	3.6 NaN
Very Good / Fair	0.0 0%	1.8 NaN
Very Good / Poor	0.0 0%	0.0 NaN
Very Good / Very Poor	0.0 0%	0.0 NaN
Good / Very Good	5.7 1.4%	8.0 NaN
Good / Good	25.0 6.1%	23.2 NaN
Good / Fair	12.5 3%	11.6 NaN
Good / Poor	0.0 0%	0.9 NaN
Good / Very Poor	0.0 0%	0.0 NaN
Fair / Very Good	3.4 0.8%	0.9 NaN
Fair / Good	14.8 3.6%	15.2 NaN
Fair / Fair	17.0 4.1%	21.4 NaN
Fair / Poor	2.3 0.6%	1.8 NaN
Fair / Very Poor	0.0 0%	0.0 NaN
Poor / Very Good	0.0 0%	0.0 NaN
Poor / Good	1.1 0.3%	0.0 NaN
Poor / Fair	1.1 0.3%	0.9 NaN
Poor / Poor	0.0 0%	0.9 NaN
Poor / Very Poor	0.0 0%	0.0 NaN
Very Poor / Very Good	0.0 0%	0.0 NaN
Very Poor / Good	0.0 0%	0.9 NaN
Very Poor / Fair	2.3 0.6%	0.0 NaN
Very Poor / Poor	1.1 0.3%	0.0 NaN
Very Poor / Very Poor	0.0 0%	0.0 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.5767
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Stratified by opioid stratum.

49. Secondary Outcome

Title	Satisfaction With Treatment at the End of Open-Label Titration Period for All Participants
Description	Satisfaction with treatment is a single-item self-rated instrument that measures the participant's overall satisfaction with the study drug during study participation on a 5-point likert scale ranging from 1 = Very dissatisfied to 5 = Very satisfied.
Time Frame	End of Open-Label Titration Period (Week 4, 5, or 6 or Early Termination)

Outcome Measure Data

Analysis Population Description

Titration Period Safety Population; percentage was based on the number of participants with non-missing response to treatment. n=number of participants analyzed for the given parameter at the specified timepoint.

Arm/Group Title	Open ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
Measure Participants	369
Very Dissatisfied (n=369)	6.8 1.7%
Dissatisfied (n=369)	7.0 1.7%
Neither Satisfied or Dissatisfied (n=369)	11.7 2.9%
Satisfied (n=369)	40.7 9.9%
Very Satisfied (n=369)	33.9 8.3%

50. Secondary Outcome

Title	Satisfaction With Treatment at Randomization Baseline
Description	Satisfaction with treatment is a single-item self-rated instrument that measures the participant's overall satisfaction with the study drug during study participation on a 5-point likert scale ranging from 1 = Very dissatisfied to 5 = Very satisfied.
Time Frame	Randomization Baseline

Outcome Measure Data

Analysis Population Description

ITT Population; percentage was based on the number of participants with non-missing response to treatment. n=number of participants analyzed for the given parameter at the specified timepoint.

Arm/Group Title	Open ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
Measure Participants	278
Very Dissatisfied (n=278)	5.4 1.3%
Dissatisfied (n=278)	2.2 0.5%
Neither Satisfied or Dissatisfied (n=278)	4.7 1.1%
Satisfied (n=278)	46.0 11.2%
Very Satisfied (n=278)	41.7 10.2%

51. Secondary Outcome

Title	Percentage of Participants Who Reported Being Satisfied/Very Satisfied With Treatment on the Satisfaction With Treatment Questionnaire During the Double-Blind Treatment Period
Description	Participants used an electronic tablet at the center to rate their overall treatment satisfaction with study drug during study participation using a 5-point categorical scale (1 = very dissatisfied, 2 = dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = satisfied, 5 = very satisfied).
Time Frame	Week 12 or Early Termination

Outcome Measure Data

Analysis Population Description

ITT Population; percentage was based on the number of participants with non-missing response to treatment. n=number of participants analyzed for the given parameter at the specified timepoint.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	125	128
Yes (n=125,128)	59.2 14.4%	79.7 NaN
No (n=125,128)	40.8 10%	20.3 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0004
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Stratified by opioid stratum.

52. Secondary Outcome

Title	Change From Screening Period to the End of Open-Label Titration Period in Short Form-36v2 (SF-36v2) Health Survey Score
Description	SF-36v2 Health Survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health aspects; physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. These domains also combine to form two component summary scores evaluating mental health and physical health. The minimum score is 0 and the maximum score is 100. A higher scores indicates a better health state.
Time Frame	Screening, Week 6 (or Early Termination)

Outcome Measure Data

Analysis Population Description

Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.

Arm/Group Title	Open ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
Measure Participants	410
Physical Functioning (n=366)	6.7 (8.96)
Role-Physical (n=366)	7.7 (9.48)
Bodily Pain (n=366)	9.8 (8.44)
General Health (n=367)	2.3 (6.54)
Vitality (n=366)	4.6 (8.98)
Social Functioning (n=367)	5.0 (11.01)
Role-Emotional (n=367)	3.4 (12.19)
Mental Health (n=367)	2.3 (8.76)
Physical Component Score (n=364)	8.2 (7.90)
Mental Component Score (n=364)	1.6 (10.05)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo
	Comments	Change from Screening Period value to End of Open-Label Titration Period for Physical Functioning.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo
	Comments	Change from Screening Period value to End of Open-Label Titration Period for Role-Physical.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo
	Comments	Change from Screening Period value to End of Open-Label Titration Period for Bodily Pain.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo
	Comments	Change from Screening Period value to End of Open-Label Titration Period for General Health.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo
	Comments	Change from Screening Period value to End of Open-Label Titration Period for Vitality.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo
	Comments	Change from Screening Period value to End of Open-Label Titration Period for Social Functioning.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo
	Comments	Change from Screening Period value to End of Open-Label Titration Period for Role-Emotional.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo
	Comments	Change from Screening Period value to End of Open-Label Titration Period for Mental Health.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo
	Comments	Change from Screening Period value to End of Open-Label Titration Period for Physical Component Score.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo
	Comments	Change from Screening Period value to End of Open-Label Titration Period for Mental Component Score.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0026
	Comments
	Method	t-test, 2 sided
	Comments

53. Secondary Outcome

Title	Change From Screening Period to Randomization Baseline in SF-36v2 Health Survey Score
Description	SF-36v2 Health Survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health aspects; physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. These domains also combine to form two component summary scores evaluating mental health and physical health. The minimum score is 0 and the maximum score is 100. A higher score indicate a better health state.
Time Frame	Screening, Randomization Baseline

Outcome Measure Data

Analysis Population Description

ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.

Arm/Group Title	Open ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
Measure Participants	280
Physical Functioning (n=276)	8.0 (8.90)
Role-Physical (n=276)	9.1 (9.40)
Bodily Pain (n=276)	11.6 (7.91)
General Health (n=277)	3.1 (6.65)
Vitality (n=276)	5.8 (9.08)
Social Functioning (n=277)	7.0 (10.27)
Role-Emotional (n=277)	4.7 (12.04)
Mental Health (n=277)	3.5 (8.29)
Physical Component Score (n=274)	9.6 (7.77)
Mental Component Score (n=274)	2.9 (9.69)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo
	Comments	Change from Screening Period value to Randomization Baseline for Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, Mental Health, Physical Component Score, and Mental Component Score
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments

54. Secondary Outcome

Title	Change From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey
Description	SF-36v2 Health Survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health aspects; physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. These domains also combine to form two component summary scores evaluating mental health and physical health. The minimum score is 0 and the maximum score is 100. A higher score indicate a better health state.
Time Frame	Randomization Baseline, Week 12

Outcome Measure Data

Analysis Population Description

ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	134	146
Physical Functioning (n=122,125)	-2.06 (0.681)	-1.44 (0.666)
Role-Physical (n=124,126)	-2.56 (0.713)	-2.59 (0.701)
Bodily Pain (n=124,127)	-5.07 (0.655)	-2.69 (0.643)
General Health Perceptions (n=124,126)	-1.55 (0.545)	-2.10 (0.536)
Vitality (n=123,127)	-1.62 (0.781)	-2.77 (0.762)
Social Functioning (n=124,127)	-3.17 (0.748)	-1.69 (0.734)
Role-Emotional (n=124,127)	-2.57 (0.963)	-3.44 (0.943)
Mental Health (n=124,127)	-2.95 (0.711)	-2.93 (0.697)
Physical Component Score (n=121,125)	-2.70 (0.635)	-1.68 (0.620)
Mental Component Score (n=121,125)	-2.29 (0.767)	-2.98 (0.749)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Randomization Baseline for Physical Functioning.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.5181
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.62
	Confidence Interval	(2-Sided) 95%; -1.26 to 2.49
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.952
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Randomization Baseline for Role-Physical.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9733
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.03
	Confidence Interval	(2-Sided) 95%; -2.00 to 1.93
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.998
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Randomization Baseline for Bodily Pain.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0100
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	2.37
	Confidence Interval	(2-Sided) 95%; 0.57 to 4.18
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.914
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Randomization Baseline for General Health Perceptions.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4712
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.55
	Confidence Interval	(2-Sided) 95%; -2.06 to 0.95
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.764
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Randomization Baseline for Vitality.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2898
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-1.16
	Confidence Interval	(2-Sided) 95%; -3.30 to 0.99
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.091
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Randomization Baseline for Social Functioning.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1565
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.48
	Confidence Interval	(2-Sided) 95%; -0.57 to 3.54
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.044
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Randomization Baseline for Role-Emotional.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.5220
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.86
	Confidence Interval	(2-Sided) 95%; -3.52 to 1.79
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.348
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Randomization Baseline for Mental Health.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9865
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.02
	Confidence Interval	(2-Sided) 95%; -1.94 to 1.98
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.995
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Randomization Baseline for Physical Component Score.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2491
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.02
	Confidence Interval	(2-Sided) 95%; -0.72 to 2.77
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.885
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Randomization Baseline for Mental Component Score.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.5219
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.69
	Confidence Interval	(2-Sided) 95%; -2.80 to 1.43
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.073
	Estimation Comments

55. Secondary Outcome

Title	Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey
Description	SF-36v2 Health Survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health aspects; physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. These domains also combine to form two component summary scores evaluating mental health and physical health. The minimum score is 0 and the maximum score is 100. A higher score indicate a better health state.
Time Frame	Screening, Week 12

Outcome Measure Data

Analysis Population Description

ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	134	146
Physical Functioning (n=123,126)	5.32 (0.794)	6.84 (0.787)
Role-Physical (n=125,127)	5.68 (0.805)	6.78 (0.802)
Bodily Pain (n=125,127)	6.39 (0.747)	8.78 (0.743)
General Health Perceptions (n=125,126)	1.28 (0.611)	1.07 (0.609)
Vitality (n=125,127)	3.46 (0.798)	3.01 (0.794)
Social Functioning (n=125,127)	3.58 (0.771)	5.57 (0.768)
Role-Emotional (n=125,127)	0.99 (0.979)	1.22 (0.975)
Mental Health (n=125,127)	0.09 (0.752)	0.47 (0.748)
Physical Component Score (n=123,126)	6.42 (0.721)	8.09 (0.715)
Mental Component Score (n=123,126)	-0.44 (0.816)	-0.45 (0.808)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Screening for Physical Functioning.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1731
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.52
	Confidence Interval	(2-Sided) 95%; -0.67 to 3.71
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.111
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Screening for Role-Physical.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.3290
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.10
	Confidence Interval	(2-Sided) 95%; -1.12 to 3.32
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.127
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Screening for Bodily Pain.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0232
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	2.39
	Confidence Interval	(2-Sided) 95%; 0.33 to 4.45
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.047
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Screening for General Health Perceptions.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8139
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.20
	Confidence Interval	(2-Sided) 95%; -1.89 to 1.49
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.858
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Screening for Vitality.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.6878
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.45
	Confidence Interval	(2-Sided) 95%; -2.65 to 1.75
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.117
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Screening for Social Functioning.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0658
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	2.00
	Confidence Interval	(2-Sided) 95%; -0.13 to 4.12
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.080
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Screening for Role-Emotional.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8670
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.23
	Confidence Interval	(2-Sided) 95%; -2.48 to 2.94
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.374
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Screening for Mental Health.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7259
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.37
	Confidence Interval	(2-Sided) 95%; -1.71 to 2.45
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.056
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Screening for Physical Component Score.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0989
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.67
	Confidence Interval	(2-Sided) 95%; -0.32 to 3.65
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.007
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Difference between treatment groups in change from Screening for Mental Component Score.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9969
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.00
	Confidence Interval	(2-Sided) 95%; -2.25 to 2.25
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.142
	Estimation Comments

56. Secondary Outcome

Title	Change From Screening Period to the End of Open-Label Titration Period in Participant Assessment of Overall Health State Using the EuroQol 5-Dimensions (EQ-5D) Summary Index
Description	The EQ 5D Health Questionnaire is a self completion standardized instrument for use as a measure of health-related quality of life in terms of a single index value or utility score that consisted of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which was rated on a 3-point response scale (no problems/some or moderate problems/extreme problems), and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health.
Time Frame	Screening, Week 6 (or Early Termination)

Outcome Measure Data

Analysis Population Description

Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.

Arm/Group Title	Open ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
Measure Participants	410
Screening (n=400)	0.68 (0.174)
End of Open-Label (n=354)	0.80 (0.134)
Change from Screening (n=346)	0.12 (0.174)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments

57. Secondary Outcome

Title	Change From Screening Period to the End of Open-Label Titration Period in Participant Assessment of Overall Health State Using the EQ-5D VAS
Description	The EQ-5D consists of a standard vertical 20cm visual analogue scale (EQ VAS), for recording a participant's rating for their current health related quality of life state; the scale went from 0 (worst imaginable health state) to 100 (best imaginable health state). Participants were asked to draw a line on the scale to indicate how good or bad your own health is today, in your opinion.
Time Frame	Screening, Week 6 (or Early Termination)

Outcome Measure Data

Analysis Population Description

Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.

Arm/Group Title	Open ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
Measure Participants	410
Screening (n=406)	66.23 (18.277)
End of Open-Label (n=367)	74.69 (18.204)
Change from Screening (n=364)	8.16 (19.398)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments

58. Secondary Outcome

Title	Change From Screening Period to Randomization Baseline in Participant Assessment of Overall Health State Using the EQ-5D Summary Index
Description	Self-completion standardized instrument for use as a measure of health-related quality of life in terms of a single index value or utility score that consisted of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which was rated on a 3-point response scale (no problems/some or moderate problems/extreme problems), and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health
Time Frame	Screening, Randomization Baseline

Outcome Measure Data

Analysis Population Description

ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.

Arm/Group Title	Open ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
Measure Participants	280
Screening (n=272)	0.68 (0.178)
Randomization Baseline (n=267)	0.82 (0.120)
Change from Screening (n=260)	0.14 (0.177)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments

59. Secondary Outcome

Title	Change From Screening Period to Randomization Baseline in Participant Assessment of Overall Health State Using the EQ-5D VAS
Description	The EQ-5D consists of a standard vertical 20cm visual analogue scale (EQ VAS), for recording a participant's rating for their current health related quality of life state; the scale went from 0 (worst imaginable health state) to 100 (best imaginable health state). Participants were asked to draw a line on the scale to indicate how good or bad your own health is today, in your opinion.
Time Frame	Screening, Randomization Baseline

Outcome Measure Data

Analysis Population Description

ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.

Arm/Group Title	Open ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
Measure Participants	280
Screening (n=279)	67.02 (18.518)
Randomization Baseline (n=276)	76.85 (17.407)
Change from Screening (n=275)	9.84 (19.692)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments

60. Secondary Outcome

Title	Change From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using EQ-5D Summary Index
Description	Self-completion standardized instrument for use as a measure of health-related quality of life in terms of a single index value or utility score that consisted of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which was rated on a 3-point response scale (no problems/some or moderate problems/extreme problems), and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health
Time Frame	Randomization Baseline, Week 12

Outcome Measure Data

Analysis Population Description

ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	118	115
Least Squares Mean (Standard Error) [Score on a scale]	-0.061 (0.0118)	-0.029 (0.0120)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0605
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of study drug during the Titration Period as covariates.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.032
	Confidence Interval	(2-Sided) 95%; -0.001 to 0.065
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.0168
	Estimation Comments

61. Secondary Outcome

Title	Change From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using the EQ-5D VAS
Description	The EQ-5D consists of a standard vertical 20cm visual analogue scale (EQ VAS), for recording a participant's rating for their current health related quality of life state; the scale went from 0 (worst imaginable health state) to 100 (best imaginable health state). Participants were asked to draw a line on the scale to indicate how good or bad your own health is today, in your opinion.
Time Frame	Randomization Baseline, Week 12

Outcome Measure Data

Analysis Population Description

ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	122	126
Least Squares Mean (Standard Error) [Score on a scale]	-3.61 (1.432)	-2.89 (1.401)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7196
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors; Randomization Baseline score and final total daily dose of study drug during the Titration Period as covariates.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.72
	Confidence Interval	(2-Sided) 95%; -3.22 to 4.66
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.999
	Estimation Comments

62. Secondary Outcome

Title	Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using EQ-5D Summary Index
Description	Self-completion standardized instrument for use as a measure of health-related quality of life in terms of a single index value or utility score that consisted of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which was rated on a 3-point response scale (no problems/some or moderate problems/extreme problems), and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health.
Time Frame	Screening, Week 12

Outcome Measure Data

Analysis Population Description

ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	121	117
Least Squares Mean (Standard Error) [Score on a scale]	0.085 (0.0121)	0.106 (0.0124)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2280
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.021
	Confidence Interval	(2-Sided) 95%; -0.013 to 0.055
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.0172
	Estimation Comments

63. Secondary Outcome

Title	Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using EQ-5D VAS
Description	The EQ-5D consists of a standard vertical 20cm visual analogue scale (EQ VAS), for recording a participant's rating for their current health related quality of life state; the scale went from 0 (worst imaginable health state) to 100 (best imaginable health state). Participants were asked to draw a line on the scale to indicate how good or bad your own health is today, in your opinion.
Time Frame	Screening, Week 12

Outcome Measure Data

Analysis Population Description

ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	124	127
Least Squares Mean (Standard Error) [Score on a scale]	4.75 (1.465)	7.01 (1.454)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2701
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	2.26
	Confidence Interval	(2-Sided) 95%; -1.77 to 6.30
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.048
	Estimation Comments

64. Secondary Outcome

Title	Change From Screening Period to End of Open-Label in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP): % Work Time Missed, % Impairment, % Overall Work Impairment, % Activity Impairment Due to Low Back Pain
Description	A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment /absenteeism+presenteeism); and activity impairment. work time missed - a measure of absenteeism, calculated as work time missed due to health problem (question 2) as a proportion of hours actually worked (question 4). impairment while working - a measure of presenteeism, the degree to which health problem impacted work (question 5). overall work impairment - a measure of overall work productivity loss due to health problem (absenteeism+presenteeism). activity impairment - a measure of the degree to which health problem has affected ability to do regular activities other than work at a job (question 6). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity.
Time Frame	Screening, Week 6 (or Early Termination)

Outcome Measure Data

Analysis Population Description

Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.

Arm/Group Title	Open ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
Measure Participants	410
Percent Work Time Missed (n=119)	-1.3 (16.66)
Percent Impairment While Working (n=112)	-22.4 (26.95)
Percent Overall Work Impairment (n=110)	-21.6 (29.83)
Percent Activity Impairment (n=363)	-27.2 (24.45)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo
	Comments	Change from Screening Period value to End of Open-Label for % Work Time Missed due to Low Back Pain.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.3822
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo
	Comments	Change from Screening Period value to End of Open-Label for % Impairment while Working due to Low Back Pain.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo
	Comments	Change from Screening Period value to End of Open-Label for % Overall Work Impairment due to Low Back Pain.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo
	Comments	Change from Screening Period value to End of Open-Label for % Activity Impairment due to Low Back Pain.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments

65. Secondary Outcome

Title	Change From Screening Period to Randomization Baseline in WPAI:SHP: Percent Work Time Missed, Percent Impairment, Percent Overall Work Impairment, Percent Activity Impairment Due to Low Back Pain
Description	A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. work time missed - a measure of absenteeism, calculated as work time missed due to health problem (question 2) as a proportion of hours actually worked (question 4). impairment while working - a measure of presenteeism, the degree to which health problem impacted work (question 5). overall work impairment - a measure of overall work productivity loss due to health problem (absenteeism+presenteeism). activity impairment - a measure of the degree to which health problem has affected ability to do regular activities other than work at a job (question 6). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity.
Time Frame	Screening, Randomization Baseline

Outcome Measure Data

Analysis Population Description

ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.

Arm/Group Title	Open ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
Measure Participants	280
Percent Work Time Missed (n=91)	-4.9 (14.37)
Percent Impairment While Working (n=86)	-25.9 (27.24)
Percent Overall Work Impairment (n=85)	-26.9 (27.76)
Percent Activity Impairment (n=273)	-32.0 (23.96)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo
	Comments	Change from Screening Period value to Randomization Baseline for % Work Time Missed due to Low Back Pain
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0017
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo
	Comments	Change from Screening Period value to Randomization Baseline for % Impairment while Working due to Low Back Pain
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo
	Comments	Change from Screening Period value to Randomization Baseline for % Overall Work Impairment due to Low Back Pain
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo
	Comments	Change from Screening Period value to Randomization Baseline for % Activity Impairment due to Low Back Pain
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments

66. Secondary Outcome

Title	Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Work Time Missed Due to Low Back Pain
Description	A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % work time missed - a measure of absenteeism, calculated as work time missed due to health problem (question 2) as a proportion of hours actually worked (question 4). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity.
Time Frame	Randomization Baseline, Weeks 4, 8, and 12

Outcome Measure Data

Analysis Population Description

ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	44	56
Week 4 (n=36,44)	3.54 (2.213)	-0.77 (1.906)
Week 8 (n=25,41)	4.29 (3.507)	1.41 (2.592)
Week 12/ET (n=40,50)	6.49 (3.108)	3.72 (2.675)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Week 4
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1389
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-4.31
	Confidence Interval	(2-Sided) 95%; -10.06 to 1.43
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.883
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Week 8
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.5094
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-2.88
	Confidence Interval	(2-Sided) 95%; -11.56 to 5.80
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 4.340
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Week 12/ET
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4944
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-2.77
	Confidence Interval	(2-Sided) 95%; -10.81 to 5.26
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 4.043
	Estimation Comments

67. Secondary Outcome

Title	Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Impairment Due to Low Back Pain
Description	A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % impairment while working - a measure of presenteeism, the degree to which health problem impacted work (question 5). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity.
Time Frame	Randomization Baseline, Weeks 4, 8, and 12

Outcome Measure Data

Analysis Population Description

ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	42	54
Week 4 (n=30,42)	5.22 (3.366)	-1.54 (2.734)
Week 8 (n=21,37)	3.63 (4.318)	-1.36 (3.027)
Week 12/ET (n=35,46)	6.77 (3.475)	4.39 (2.918)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Week 4
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1201
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-6.76
	Confidence Interval	(2-Sided) 95%; -15.33 to 1.81
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 4.295
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Week 8
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.3497
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-4.99
	Confidence Interval	(2-Sided) 95%; -15.60 to 5.62
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 5.288
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Week 12/ET
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.6008
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-2.38
	Confidence Interval	(2-Sided) 95%; -11.41 to 6.65
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 4.532
	Estimation Comments

68. Secondary Outcome

Title	Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Overall Work Impairment Due to Low Back Pain
Description	A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % overall work impairment - a measure of overall work productivity loss due to health problem (absenteeism+presenteeism). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity.
Time Frame	Randomization Baseline, Weeks 4, 8, and 12

Outcome Measure Data

Analysis Population Description

ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	42	53
Week 4 (n=30,42)	5.31 (3.894)	-2.03 (3.147)
Week 8 (n=21,37)	8.69 (5.276)	-0.66 (3.666)
Week 12/ET (n=35,46)	10.85 (4.266)	5.71 (3.575)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Week 4
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1458
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-7.34
	Confidence Interval	(2-Sided) 95%; -17.29 to 2.62
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 4.986
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Week 8
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1558
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-9.35
	Confidence Interval	(2-Sided) 95%; -22.38 to 3.68
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 6.496
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Week 12/ET
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.3604
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-5.14
	Confidence Interval	(2-Sided) 95%; -16.25 to 5.98
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 5.582
	Estimation Comments

69. Secondary Outcome

Title	Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Activity Impairment Due to Low Back Pain
Description	A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % activity impairment - a measure of the degree to which health problem has affected ability to do regular activities other than work at a job (question 6). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity.
Time Frame	Randomization Baseline, Weeks 4, 8, and 12

Outcome Measure Data

Analysis Population Description

ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	131	144
Week 4 (n=108,125)	6.23 (1.768)	1.98 (1.626)
Week 8 (n=85,112)	2.05 (2.044)	3.05 (1.752)
Week 12/ET (n=128,135)	10.56 (1.818)	6.41 (1.758)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Week 4
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0768
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-4.25
	Confidence Interval	(2-Sided) 95%; -8.95 to 0.46
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.389
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Week 8
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7109
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 95%; -4.30 to 6.29
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.684
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Week 12/ET
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1031
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-4.15
	Confidence Interval	(2-Sided) 95%; -9.14 to 0.85
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.536
	Estimation Comments

70. Secondary Outcome

Title	Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Work Time Missed Due to Low Back Pain
Description	A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % work time missed - a measure of absenteeism, calculated as work time missed due to health problem (question 2) as a proportion of hours actually worked (question 4). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity.
Time Frame	Screening, Weeks 4, 8, and 12

Outcome Measure Data

Analysis Population Description

ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	46	58
Week 4 (n=36,43)	-0.09 (2.147)	-4.82 (1.911)
Week 8 (n=24,40)	-1.42 (2.785)	-3.01 (2.123)
Week 12/ET (n=40,49)	-1.00 (2.612)	-2.09 (2.307)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Week 4
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0926
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-4.73
	Confidence Interval	(2-Sided) 95%; -10.26 to 0.80
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.776
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Week 8
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.6437
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-1.59
	Confidence Interval	(2-Sided) 95%; -8.42 to 5.24
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.414
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Week 12/ET
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7480
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-1.09
	Confidence Interval	(2-Sided) 95%; -7.84 to 5.65
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.391
	Estimation Comments

71. Secondary Outcome

Title	Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Impairment Due to Low Back Pain
Description	A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % impairment while working - a measure of presenteeism, the degree to which health problem impacted work (question 5). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity.
Time Frame	Screening, Weeks 4, 8, and 12

Outcome Measure Data

Analysis Population Description

ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	47	56
Week 4 (n=33,42)	-18.65 (3.614)	-31.03 (3.151)
Week 8 (n=22,37)	-16.43 (4.374)	-29.37 (3.263)
Week 12/ET (n=38,46)	-16.18 (3.642)	-25.38 (3.242)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Week 4
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0098
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-12.38
	Confidence Interval	(2-Sided) 95%; -21.68 to -3.07
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 4.666
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Week 8
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0186
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-12.94
	Confidence Interval	(2-Sided) 95%; -23.63 to -2.25
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 5.336
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Week 12/ET
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0581
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-9.20
	Confidence Interval	(2-Sided) 95%; -18.72 to 0.32
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 4.785
	Estimation Comments

72. Secondary Outcome

Title	Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Overall Work Impairment Due to Low Back Pain
Description	A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % overall work impairment - a measure of overall work productivity loss due to health problem (absenteeism+presenteeism). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity.
Time Frame	Screening, Weeks 4, 8, and 12

Outcome Measure Data

Analysis Population Description

ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	46	56
Week 4 (n=32,41)	-19.84 (3.992)	-32.40 (3.470)
Week 8 (n=21,37)	-15.21 (4.933)	-29.37 (3.608)
Week 12/ET (n=37,46)	-15.16 (4.268)	-25.51 (3.759)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Week 4
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0177
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-12.56
	Confidence Interval	(2-Sided) 95%; -22.87 to -2.25
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 5.168
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Week 8
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0219
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-14.16
	Confidence Interval	(2-Sided) 95%; -26.19 to -2.14
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 5.998
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Week 12/ET
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0679
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-10.35
	Confidence Interval	(2-Sided) 95%; -21.47 to 0.78
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 5.589
	Estimation Comments

73. Secondary Outcome

Title	Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Activity Impairment Due to Low Back Pain
Description	A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % activity impairment - a measure of the degree to which health problem has affected ability to do regular activities other than work at a job (question 6). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity.
Time Frame	Screening, Weeks 4, 8, and 12

Outcome Measure Data

Analysis Population Description

ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	133	145
Week 4 (n=109,125)	-23.75 (1.960)	-31.24 (1.829)
Week 8 (n=87,112)	-25.25 (2.279)	-29.87 (2.005)
Week 12/ET (n=130,136)	-18.62 (2.025)	-26.81 (1.981)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Week 4
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0052
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-7.50
	Confidence Interval	(2-Sided) 95%; -12.72 to -2.27
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.654
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Week 8
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1249
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-4.62
	Confidence Interval	(2-Sided) 95%; -10.54 to 1.29
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.999
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	ALO-02 To Placebo, ALO-02 To ALO-02
	Comments	Week 12/ET
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0040
	Comments	Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-8.19
	Confidence Interval	(2-Sided) 95%; -13.74 to -2.64
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.818
	Estimation Comments

74. Secondary Outcome

Title	Percentage of Participants With Shift From Screening Period to End of Open-Label Titration Period in Hospitalization Because of Low Back Pain as Assessed Using the Healthcare Resource Use (HRU) Questionnaire
Description	Question 3a = In the past 4 weeks, have you been hospitalized due to chronic low back pain or any medication used for chronic low back pain?
Time Frame	Screening, Week 6 (or Early Termination)

Outcome Measure Data

Analysis Population Description

Titration Period Safety Population; the denominator for the percentage calculation is the number of participants who had both Screening value and End of Open-Label value.

Arm/Group Title	Open ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
Measure Participants	362
Yes/Yes	0.3 0.1%
Yes/No	0.8 0.2%
No/Yes	2.5 0.6%
No/No	96.4 23.5%

75. Secondary Outcome

Title	Percentage of Participants With Shift From Screening Period to Randomization Baseline in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire
Description	Question 3a = In the past 4 weeks, have you been hospitalized due to chronic low back pain or any medication used for chronic low back pain?
Time Frame	Screening, Randomization Baseline

Outcome Measure Data

Analysis Population Description

ITT Population; the denominator for the percentage calculation is the number of participants who had both Screening value and Randomization Baseline value.

Arm/Group Title	Open ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
Measure Participants	272
Yes/Yes	0.4 0.1%
Yes/No	1.1 0.3%
No/Yes	2.9 0.7%
No/No	95.6 23.3%

76. Secondary Outcome

Title	Change From Screening to Randomization Baseline in HRU Questionnaire: Number of Office Visits Directly Related or Any Medication Used for Chronic Low Back Pain
Description	Question 1: number of office visits directly related to chronic low back pain or any medication used for chronic low back pain.
Time Frame	Screening, Randomization Baseline

Outcome Measure Data

Analysis Population Description

ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.

Arm/Group Title	Open ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
Measure Participants	280
Screening (n=257)	11.4 (38.97)
Randomization Baseline (n=247)	5.6 (21.84)
Change from Screening (n=234)	-4.7 (39.19)

77. Secondary Outcome

Title	Change From Screening to Randomization Baseline in HRU Questionnaire: Money Spent on Physical Treatments in Past 4 Weeks
Description	Question 2: Money (dollars) spent out-of-pocket on physical treatments in the past 4 weeks to manage chronic low back pain
Time Frame	Screening, Randomization Baseline

Outcome Measure Data

Analysis Population Description

ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.

Arm/Group Title	Open ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
Measure Participants	280
Screening (n=264)	84.7 (418.06)
Randomization Baseline (n=260)	51.8 (360.94)
Change from Screening (n=248)	-41.8 (522.53)

78. Secondary Outcome

Title	Change From Screening to Randomization Baseline in HRU Questionnaire: Nights Stayed in Hospital
Description	Question 3b: nights stayed in the hospital, if answer to Q3a was yes.
Time Frame	Screening, Randomization Baseline

Outcome Measure Data

Analysis Population Description

ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.

Arm/Group Title	Open ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
Measure Participants	280
Screening (n=9)	0.1 (0.33)
Randomization Baseline (n=3)	0.0 (0.00)
Change from Screening (n=1)	0.0 (NA)

79. Secondary Outcome

Title	Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Number of Office Visits Directly Related or Any Medication Used for Chronic Low Back Pain
Description	Question 1: number of office visits directly related to chronic low back pain or any medication used for chronic low back pain.
Time Frame	Screening, Week 6 (or Early Termination)

Outcome Measure Data

Analysis Population Description

Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.

Arm/Group Title	Open ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
Measure Participants	410
Screening (n=373)	8.8 (33.07)
Randomization Baseline (n=325)	5.4 (20.58)
Change from Screening (n=308)	-3.0 (35.29)

80. Secondary Outcome

Title	Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Money Spent on Physical Treatments in Past 4 Weeks
Description	Question 2: Money (dollars) spent out-of-pocket on physical treatments in the past 4 weeks to manage chronic low back pain
Time Frame	Screening, Week 6 (or Early Termination)

Outcome Measure Data

Analysis Population Description

Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.

Arm/Group Title	Open ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
Measure Participants	410
Screening (n=388)	104.1 (605.48)
Randomization Baseline (n=343)	88.0 (674.20)
Change from Screening (n=329)	-28.3 (548.03)

81. Secondary Outcome

Title	Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Nights Stayed in Hospital
Description	Question 3b: nights stayed in the hospital, if answer to Q3a was yes.
Time Frame	Screening, Week 6 (or Early Termination)

Outcome Measure Data

Analysis Population Description

Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.

Arm/Group Title	Open ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
Measure Participants	410
Screening (n=9)	0.1 (0.33)
Randomization Baseline (n=3)	0.0 (0.00)
Change from Screening (n=1)	0.0 (NA)

82. Secondary Outcome

Title	Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire
Description	Question 3a = In the past 4 weeks, have you been hospitalized due to chronic low back pain or any medication used for chronic low back pain?
Time Frame	Randomization Baseline, Weeks 4, 8, and 12 (or Early Termination)

Outcome Measure Data

Analysis Population Description

ITT Population; the denominator for the percentage calculation is the number of participants who had both Randomization Baseline value and Post Randomization value for each treatment and visit. Imputation using the LOCF method.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	134	146
Yes/Yes Week 4 (n=108, 123)	0.0 0%	0.0 NaN
Yes/No Week 4 (n=108, 123)	3.7 0.9%	0.8 NaN
No/Yes Week 4 (n=108, 123)	1.9 0.5%	0.0 NaN
No/No Week 4 (n=108, 123)	94.4 23%	99.2 NaN
Yes/Yes Week 8 (n=85, 110)	0.0 0%	0.0 NaN
Yes/No Week 8 (n=85, 110)	1.2 0.3%	0.9 NaN
No/Yes Week 8 (n=85, 110)	2.4 0.6%	0.0 NaN
No/No Week 8 (n=85, 110)	96.5 23.5%	99.1 NaN
Yes/Yes Week12/ET (n=129, 134)	0.0 0%	0.0 NaN
Yes/No Week12/ET (n=129, 134)	3.1 0.8%	0.0 NaN
No/Yes Week12/ET (n=129, 134)	1.6 0.4%	0.7 NaN
No/No Week 12/ET (n=129, 134)	95.3 23.2%	99.3 NaN

83. Secondary Outcome

Title	Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related to or Medications Used for Chronic Low Back Pain
Description	Question 1: number of office visits directly related to chronic low back pain or any medication used for chronic low back pain
Time Frame	Randomization Baseline, Weeks 4, 8, and 12

Outcome Measure Data

Analysis Population Description

ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	134	146
Randomization Baseline (n=118,129)	4.4 (18.10)	6.6 (24.80)
Week 4 (n=100,110)	6.5 (24.35)	5.3 (37.99)
Change from Baseline at Week 4 (n=95,106)	0.1 (24.17)	-3.1 (46.85)
Week 8 (n=79,103)	22.8 (179.55)	3.3 (13.46)
Change from Baseline at Week 8 (n=74,100)	-1.2 (20.35)	-2.6 (24.31)
Week 12/ET (n=121,128)	19.2 (153.80)	4.2 (15.38)
Change from Baseline at Week 12/ET (n=112,119)	-0.3 (24.90)	-4.1 (27.74)

84. Secondary Outcome

Title	Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatments
Description	Question 2: money (dollars) spent out-of-pocket on physical treatments in the past 4 weeks to manage chronic low back pain.
Time Frame	Randomization Baseline, Weeks 4, 8, and 12

Outcome Measure Data

Analysis Population Description

ITT Population, imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	134	146
Randomization Baseline (n=124,136)	96.4 (518.89)	11.3 (33.77)
Week 4 (n=104,119)	19.9 (90.26)	15.0 (78.59)
Change from Baseline at Week 4 (n=99,117)	-24.7 (222.07)	4.4 (79.92)
Week 8 (n=81,106)	146.2 (1113.58)	16.7 (54.33)
Change from Baseline at Week 8 (n=76,105)	-0.1 (71.11)	7.5 (42.52)
Week 12/ET (n=125,133)	113.0 (913.41)	29.3 (177.85)
Change from Baseline at Week 12/ET (n=119,128)	-47.8 (461.95)	20.0 (180.70)

85. Secondary Outcome

Title	Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights Spent in Hospital
Description	Question 3b: nights stayed in the hospital
Time Frame	Randomization Baseline, Weeks 4, 8, and 12

Outcome Measure Data

Analysis Population Description

ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	134	146
Randomization Baseline (n=1,2)	0.0 (NA)	0.0 (0.00)
Week 4 (n=4,0)	0.3 (0.5)	NA (NA)
Change from Baseline at Week 4 (n=0,0)	NA (NA)	NA (NA)
Week 8 (n=1,1)	99.0 (NA)	0.0 (NA)
Change from Baseline at Week 8 (n=0,0)	NA (NA)	NA (NA)
Week 12/ET (n=4,1)	24.8 (49.50)	0.0 (NA)
Change from Baseline at Week 12/ET (n=0,0)	NA (NA)	NA (NA)

86. Secondary Outcome

Title	Percentage of Participants With Shift From Screening Period to the End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire
Description	Question 3a = In the past 4 weeks, have you been hospitalized due to chronic low back pain or any medication used for chronic low back pain?
Time Frame	Screening, Weeks 4, 8, and 12

Outcome Measure Data

Analysis Population Description

ITT Population; the denominator for the percentage calculation is the number of participants who had both Screening value and Post Screening value for each treatment and visit. Imputation using the LOCF method.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	134	146
Yes/Yes Week 4 (n=109,124)	0.9 0.2%	0.0 NaN
Yes/No Week 4 (n=109,124)	2.8 0.7%	0.8 NaN
No/Yes Week 4 (n=109,124)	2.8 0.7%	1.6 NaN
No/No Week 4 (n=109,124)	93.6 22.8%	97.6 NaN
Yes/Yes Week 8 (n=86,111)	0.0 0%	0.0 NaN
Yes/No Week 8 (n=86, 111)	1.2 0.3%	0.9 NaN
No/Yes Week 8 (n=86, 111)	2.3 0.6%	1.8 NaN
No/No Week 8 (n=86, 111)	96.5 23.5%	97.3 NaN
Yes/Yes Week 12/ET (n=130,136)	0.8 0.2%	0.0 NaN
Yes/No Week 12/ET (n=130,136)	2.3 0.6%	0.0 NaN
No/Yes Week 12/ET (n=130,136)	3.8 0.9%	2.2 NaN
No/No Week 12/ET (n=130,136)	93.1 22.7%	97.8 NaN

87. Secondary Outcome

Title	Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related or Medication Used for Chronic Low Back Pain
Description	Question 1: number of office visits directly related to chronic low back pain or any medication used for chronic low back pain
Time Frame	Screening, Weeks 4, 8, and 12

Outcome Measure Data

Analysis Population Description

ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	134	146
Screening (n=121,136)	8.8 (33.76)	13.7 (43.07)
Week 4 (n=100,110)	6.5 (24.35)	5.3 (37.99)
Change from Screening at Week 4 (n=94,106)	0.8 (28.99)	-7.6 (58.56)
Week 8 (n=79,103)	22.8 (179.55)	3.3 (13.46)
Change from Screening at Week 8 (n=73,100)	16.7 (188.74)	-10.4 (44.61)
Week 12/ET (n=121,128)	19.2 (153.80)	4.2 (15.38)
Change from Screening at Week 12/ET (n=114,123)	13.2 (159.55)	-7.3 (41.80)

88. Secondary Outcome

Title	Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatment for Chronic Low Back Pain
Description	Question 2: money (dollars) spent out-of-pocket on physical treatments in the past 4 weeks to manage chronic low back pain
Time Frame	Screening, Weeks 4, 8, and 12

Outcome Measure Data

Analysis Population Description

ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	134	146
Screening (n=126,138)	83.6 (277.98)	85.6 (514.80)
Week 4 (n=104,119)	19.9 (90.26)	15.0 (78.59)
Change from Screening at Week 4 (n=100,114)	-79.8 (315.79)	-80.3 (497.56)
Week 8 (n=81,106)	146.2 (1113.58)	16.7 (54.33)
Change from Screening at Week 8 (n=78,103)	56.9 (1174.87)	-84.5 (593.49)
Week 12/ET (n=125,133)	113.0 (913.41)	29.3 (177.85)
Change from Screening at Week 12/ET (n=120,128)	32.1 (944.71)	-58.1 (563.65)

89. Secondary Outcome

Title	Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights in Hospital for Chronic Low Back Pain
Description	Question 3b: nights stayed in the hospital
Time Frame	Screening, Weeks 4, 8, and 12

Outcome Measure Data

Analysis Population Description

ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	134	146
Screening (n=6,3)	0.0 (0.00)	0.3 (0.58)
Week 4 (n=4,0)	0.3 (0.50)	NA (NA)
Change from Screening at Week 4 (n=1,0)	0.0 (NA)	NA (NA)
Week 8 (n=1,1)	99.0 (NA)	0.0 (NA)
Change from Screening at Week 8 (n=0,0)	NA (NA)	NA (NA)
Week 12/ET (n=4,1)	24.8 (49.50)	0.0 (NA)
Change from Screening at Week 12/ET (n=1,0)	0.0 (NA)	NA (NA)

90. Secondary Outcome

Title	Mean Oxycodone Average Daily Dose During the Open-Label Titration Period
Time Frame	Open-Label Period

Outcome Measure Data

Analysis Population Description

Titration Period Safety Population

Arm/Group Title	Open ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
Measure Participants	410
Mean (Standard Deviation) [mg]	45.8 (22.61)

91. Secondary Outcome

Title	Mean Oxycodone Duration of Titration During the Open-Label Titration Period
Time Frame	Open-Label Period

Outcome Measure Data

Analysis Population Description

Titration Period Safety Population

Arm/Group Title	Open ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
Measure Participants	410
Mean (Standard Deviation) [days]	31.0 (12.24)

92. Secondary Outcome

Title	Median Oxycodone Average Daily Dose During the Open-Label Titration Period
Time Frame	Open-Label Period

Outcome Measure Data

Analysis Population Description

Titration Period Safety Population

Arm/Group Title	Open ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
Measure Participants	410
Median (Inter-Quartile Range) [mg]	42.3 (22.61)

93. Secondary Outcome

Title	Median Oxycodone Duration of Titration During the Open-Label Titration Period
Time Frame	Open-Label Period

Outcome Measure Data

Analysis Population Description

Titration Period Safety Population

Arm/Group Title	Open ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
Measure Participants	410
Median (Inter-Quartile Range) [days]	35.0 (12.24)

94. Secondary Outcome

Title	Mean Oxycodone Average Daily Dose During the Double-Blind Treatment Period
Time Frame	Double-Blind Period

Outcome Measure Data

Analysis Population Description

Double-Blind Safety Population

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	134	146
Mean (Standard Deviation) [mg]	70.1 (33.67)	63.6 (34.02)

95. Secondary Outcome

Title	Mean Oxycodone Duration of Treatment During the Double-Blind Treatment Period
Time Frame	Double-Blind Period

Outcome Measure Data

Analysis Population Description

Double-Blind Safety Population

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	134	146
Mean (Standard Deviation) [days]	62.7 (30.20)	70.9 (27.80)

96. Secondary Outcome

Title	Median Oxycodone Average Daily Dose During the Double-Blind Treatment Period
Time Frame	Double-Blind Period

Outcome Measure Data

Analysis Population Description

Double-Blind Safety Population

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	134	146
Median (Inter-Quartile Range) [mg]	60.0	59.6

97. Secondary Outcome

Title	Median Oxycodone Duration of Treatment During the Double-Blind Treatment Period
Time Frame	Double-Blind Period

Outcome Measure Data

Analysis Population Description

Double-Blind Safety Population

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	134	146
Median (Inter-Quartile Range) [days]	84.0	85.0

98. Secondary Outcome

Title	Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Titration Period
Description	Observed steady-state plasma concentration (Cobs) of oxycodone and noroxycodone.
Time Frame	Blood samples were taken within +/-4 hours of the morning dose of ALO-02 at Week 6/Early Termination, Randomization Baseline

Outcome Measure Data

Analysis Population Description

Titration Period Safety Population; participants assessed at Week 6 had not been randomized to the Double-Blind Period; participants assessed at Randomization Baseline had been randomized to the Double-Blind Period.

Arm/Group Title	Open ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
Measure Participants	410
Oxycodone at Week 6/ET (n=77)	14.1 (22.27)
Oxycodone at Randomization Baseline (n=267)	26.4 (28.84)
Noroxycodone at Week 6/ET (n=77)	15.5 (26.50)
Noroxycodone at Randomization Baseline (n=267)	29.9 (42.04)

99. Secondary Outcome

Title	Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Titration Period
Description	Cobs of naltrexone and 6-β-naltrexol
Time Frame	Blood samples were taken within +/-4 hours of the morning dose of ALO-02 at Week 6/Early Termination, Randomization Baseline

Outcome Measure Data

Analysis Population Description

Titration Period Safety Population; participants assessed at Week 6 had not been randomized to the Double-Blind Period; participants assessed at Randomization Baseline had been randomized to the Double-Blind Period.

Arm/Group Title	Open ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
Measure Participants	410
Naltrexone at Week 6/ET (n=77)	4.6 (19.02)
Naltrexone at Randomization Baseline (n=266)	14.6 (81.73)
6-β-naltrexol at Week 6/ET (n=77)	82.0 (305.91)
6-β-naltrexol at Randomization Baseline (n=266)	154.1 (595.80)

100. Secondary Outcome

Title	Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Double-Blind Treatment Period
Description	Observed steady-state plasma concentration (Cobs) of oxycodone and noroxycodone
Time Frame	Blood samples were taken within +/-4 hours of the morning dose of study drug at Randomization Baseline, Weeks 4, 8, and 12

Outcome Measure Data

Analysis Population Description

Double-Blind Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	134	146
Oxycodone at Baseline (n=127,140)	27.0 (29.06)	25.9 (28.73)
Oxycodone at Week 4 (n=0,116)	NA (NA)	23.3 (26.90)
Oxycodone at Week 8 (n=0,107)	NA (NA)	23.1 (23.83)
Oxycodone at Week 12/ET (n=1,137)	0.0 (NA)	22.6 (26.98)
Noroxycodone at Baseline (n=127,140)	33.1 (48.84)	27.1 (34.67)
Noroxycodone at Week 4 (n=0,116)	NA (NA)	25.5 (40.54)
Noroxycodone at Week 8 (n=0,107)	NA (NA)	26.2 (34.38)
Noroxycodone at Week 12/ET (n=1,137)	0.0 (NA)	26.3 (40.67)

101. Secondary Outcome

Title	Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Double Blind Treatment Period
Description	Observed steady-state plasma concentration (Cobs) of naltrexone and 6-β-naltrexol
Time Frame	Blood samples were taken within +/-4 hours of the morning dose of study drug at Randomization Baseline, Weeks 4, 8, and 12

Outcome Measure Data

Analysis Population Description

Double-Blind Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.

Arm/Group Title	ALO-02 To Placebo	ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Measure Participants	134	146
Naltrexone at Baseline (n=127,139)	24.9 (116.41)	5.3 (16.48)
Naltrexone at Week 4 (n=3,115)	0.0 (0.0)	3.4 (14.65)
Naltrexone at Week 8 (n=3,107)	0.0 (0.0)	2.9 (11.13)
Naltrexone at Week 12/ET (n=4,137)	0.0 (0.0)	3.0 (12.67)
6-β-naltrexol at Baseline (n=127,139)	216.0 (800.32)	97.5 (300.17)
6-β-naltrexol at Week 4 (n=3,115)	0.0 (0.0)	86.1 (315.42)
6-β-naltrexol at Week 8 (n=3,107)	0.0 (0.0)	48.3 (156.42)
6-β-naltrexol at Week 12/ET (n=4,137)	0.0 (0.0)	55.6 (163.41)

Adverse Events

Time Frame	From the time of informed consent up to and including 28 calendar days after the last administration of the investigational product.
Adverse Event Reporting Description	The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Arm/Group Title	Open ALO-02		ALO-02 To Placebo		ALO-02 To ALO-02
Arm/Group Description	Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.		Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.		Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
All Cause Mortality
	Open ALO-02		ALO-02 To Placebo		ALO-02 To ALO-02
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Open ALO-02		ALO-02 To Placebo		ALO-02 To ALO-02
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/410 (0.7%)		2/134 (1.5%)		5/146 (3.4%)
Cardiac disorders
Atrial flutter	0/410 (0%)		0/134 (0%)		1/146 (0.7%)
Myocardial infarction	0/410 (0%)		0/134 (0%)		1/146 (0.7%)
Hepatobiliary disorders
Cholecystitis	0/410 (0%)		0/134 (0%)		1/146 (0.7%)
Cholelithiasis	0/410 (0%)		0/134 (0%)		1/146 (0.7%)
Infections and infestations
Bronchitis	1/410 (0.2%)		0/134 (0%)		0/146 (0%)
Urinary tract infection	1/410 (0.2%)		0/134 (0%)		0/146 (0%)
Injury, poisoning and procedural complications
Drug administration error	0/410 (0%)		0/134 (0%)		1/146 (0.7%)
Road traffic accident	0/410 (0%)		1/134 (0.7%)		0/146 (0%)
Metabolism and nutrition disorders
Cholesterosis	0/410 (0%)		0/134 (0%)		1/146 (0.7%)
Musculoskeletal and connective tissue disorders
Arthritis	0/410 (0%)		0/134 (0%)		1/146 (0.7%)
Costochondritis	0/410 (0%)		0/134 (0%)		1/146 (0.7%)
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous	0/410 (0%)		0/134 (0%)		1/146 (0.7%)
Unintended pregnancy	0/410 (0%)		0/134 (0%)		1/146 (0.7%)
Psychiatric disorders
Depression	1/410 (0.2%)		0/134 (0%)		0/146 (0%)
Suicide attempt	1/410 (0.2%)		0/134 (0%)		0/146 (0%)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	1/410 (0.2%)		0/134 (0%)		0/146 (0%)
Vascular disorders
Intermittent claudication	0/410 (0%)		1/134 (0.7%)		0/146 (0%)
Peripheral arterial occlusive disease	0/410 (0%)		1/134 (0.7%)		0/146 (0%)
Other (Not Including Serious) Adverse Events
	Open ALO-02		ALO-02 To Placebo		ALO-02 To ALO-02
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	186/410 (45.4%)		26/134 (19.4%)		41/146 (28.1%)
Gastrointestinal disorders
Constipation	61/410 (14.9%)		3/134 (2.2%)		5/146 (3.4%)
Diarrhoea	9/410 (2.2%)		6/134 (4.5%)		8/146 (5.5%)
Nausea	84/410 (20.5%)		5/134 (3.7%)		21/146 (14.4%)
Vomiting	37/410 (9%)		4/134 (3%)		9/146 (6.2%)
Musculoskeletal and connective tissue disorders
Back pain	5/410 (1.2%)		8/134 (6%)		3/146 (2.1%)
Nervous system disorders
Dizziness	24/410 (5.9%)		1/134 (0.7%)		6/146 (4.1%)
Headache	30/410 (7.3%)		7/134 (5.2%)		2/146 (1.4%)
Somnolence	36/410 (8.8%)		1/134 (0.7%)		1/146 (0.7%)
Skin and subcutaneous tissue disorders
Pruritus	26/410 (6.3%)		0/134 (0%)		2/146 (1.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.