NUCYNTA (Tapentadol Immediate Release) Versus Oxycodone Immediate Release in the Treatment of Acute Low Back Pain

• Sponsor: Ortho-McNeil Janssen Scientific Affairs, LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00986180
• Collaborator: Grünenthal GmbH (Industry)
• Enrollment: 667
• Locations: 74
• Arms: 2
• Duration (Months): 15
• Patients Per Site: 9
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

Evaluate how NUCYNTA (tapentadol) immediate release (IR) compares with oxycodone IR in the treatment of acute low back pain.

Condition or Disease	Intervention/Treatment	Phase
Pain; Back Pain; Low Back Pain; Back Pain With Radiation	Drug: NUCYNTA; Drug: Oxycodone IR	Phase 3

Detailed Description

This is a randomized, outpatient, multicenter, double-blind study (blinded to patient and to study doctor) comparing NUCYNTA to oxycodone IR in the treatment of patients with acute (new onset) low back pain who also have associated leg pain that radiates (travels down) below the knee. Patients will be screened for study eligibility at Visit 1. The study will be explained and informed consent will be obtained. Potential patients must satisfy all eligibility criteria to be enrolled in the study. Eligible candidates will proceed to the Double-Blind Treatment Phase. At the time of study entry, all prohibited medications will be discontinued and will be disallowed throughout the study. All patients will call into an interactive voice response system (IVRS) to complete a pain assessments twice daily throughout the study. Patients who discontinue early for any reason will be instructed to contact the study site to complete final assessments, prior to taking supplemental pain medication if applicable, and to schedule a final study visit. All patients will return to the study site on Day 5 (Visit 2) where they will be evaluated by study personnel and, as appropriate, continue with study treatment for an additional 5 days. Patients will return to the study site for the final visit on Day 10/End of Study (Visit 3) when they will have all final study assessments. The treatment duration will be up to 10 days. The sponsor will collect adverse events starting with the signing of the informed consent form. Adverse events will be reported by the subject for the duration of the study. Any clinically significant abnormalities persisting at the end of the study will be followed by the investigator until resolution or until a clinically stable endpoint is reached. Blood samples for serum chemistry and hematology and a urine sample for urinalysis will be collected. The investigator will review the laboratory report, document this review, and record any clinically relevant changes occurring during the study. The following tests will be performed by the central laboratory: Urine Pregnancy Testing for women of childbearing potential only, Urine Drug Screen, Vital Signs (pulse rate and blood pressure), Physical Examination, Neurological Examination, and Vomiting Assessment. The study will be conducted at approximately 80 sites in the United States (US). Patients will be randomized to one of the two following treatment groups: NUCYNTA 50, 75 or 100 mg every 4 to 6 hours up to 10 days as needed for pain. Oxycodone IR 5, 10 or 15 mg every 4 to 6 hours as needed for pain. Patients will begin treatment on Day 1 with one "lower dose" capsule of study drug (NUCYNTA 50 mg or oxycodone IR 5 mg). Subsequent dose adjustments will be made by study patients, as needed, to achieve a dose that provides a meaningful improvement in their pain intensity

Study Design

• Study Type: Interventional
• Actual Enrollment: 667 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-Blind, Parallel-Group Study of NUCYNTA (Tapentadol) Immediate Release vs. Oxycodone Immediate Release for the Treatment of Acute Low Back Pain
• Study Start Date: Sep 1, 2009
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 001 NUCYNTA 50 75 or 100 mg every 4 to 6 hours for up to 10 days as needed for pain	Drug: NUCYNTA; 50, 75, or 100 mg every 4 to 6 hours for up to 10 days as needed for pain
Active Comparator: 002 Oxycodone IR 5 10 or 15 mg every 4 to 6 hours for up to 10 days as needed for pain	Drug: Oxycodone IR; 5, 10, or 15 mg every 4 to 6 hours for up to 10 days as needed for pain

Outcome Measures

Primary Outcome Measures

1. Sum of Pain Intensity Difference (SPID) for Low Back Pain - Summary Statistics at 120 Hours (With Imputation) [0 hour (prior to first dose) and 120 hours]

   Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 120 hours.

Secondary Outcome Measures

1. Sum of Pain Intensity Difference (SPID) for Low Back Pain - Summary Statistics at 2 Days (With Imputation) [Day 0 and Day 2]

   Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 2 days.

2. SPID for Low Back Pain - Summary Statistics at 3 Days (With Imputation) [Day 0 and Day 3]

   Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 3 days.

3. SPID for Low Back Pain - Summary Statistics at 10 Days (With Imputation) [Day 0 and Day 10]

   Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 10 days.

4. SPID for Index Leg Pain - Summary Statistics at 2 Days (With Imputation) [Day 0 and Day 2]

   Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 2 days.

5. SPID for Index Leg Pain - Summary Statistics at 3 Days (With Imputation) [Day 0 and Day 3]

   Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 3 days.

6. SPID for Index Leg Pain - Summary Statistics at 5 Days (With Imputation) [Day 0 and Day 5]

   Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 5 days.

7. SPID for Index Leg Pain - Summary Statistics at 10 Days (With Imputation) [Day 0 and Day 10]

   Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 10 days.

8. Total Pain Relief (TOTPAR) for Low Back Pain - Summary Statistics at 5 Days [Day 0 and Day 5]

   Pain Relief - 5-Point Numerical Rating Scale, 0=None, 4=Complete. Total Pain Relief (TOTPAR) is a weighted sum of pain relieve over a specified time period, say 5 days.

9. SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Continuous Pain Day 5 [Day 0 and Day 5]

   Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Continuous pain subscale descriptors include: throbbing pain, cramping pain, gnawing pain, aching pain, heavy pain, and tender.

10. SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Continuous Pain Day 10/Last Visit [Day 0 and Day 10]

    Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Continuous pain subscale descriptors include: throbbing pain, cramping pain, gnawing pain, aching pain, heavy pain, and tender.

11. SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Intermittent Pain Day 5 [Day 0 and Day 5]

    Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Intermittent pain subscale descriptors include: shooting pain, stabbing pain, sharp pain, splitting pain, electric-shock pain, and piercing.

12. SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Intermittent Pain Day 10/Last Visit [Day 0 and Day 10]

    Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Intermittent pain subscale descriptors include: shooting pain, stabbing pain, sharp pain, splitting pain, electric-shock pain, and piercing.

13. SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Neuropathic Pain Day 5 [Day 0 and Day 5]

    Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Predominantly neuropathic pain subscale descriptors include: hot-burning pain, cold-freezing pain, pain caused by light touch, itching, tingling or "pins and needles" and numbness.

14. SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Neuropathic Pain Day 10/Last Visit [Day 0 and Day 10]

    Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Predominantly neuropathic pain subscale descriptors include: hot-burning pain, cold-freezing pain, pain caused by light touch, itching, tingling or "pins and needles" and numbness.

15. SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Affective Descriptors Day 5 [Day 0 and Day 5]

    Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Affective subscale descriptors include: tiring-exhausting, sickening, fearful, and punishing-cruel.

16. SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Affective Descriptors Day 10/Last Visit [Day 0 and Day 10]

    Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Affective subscale descriptors include: tiring-exhausting, sickening, fearful, and punishing-cruel.

17. SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Total Score Day 5 [Day 0 and Day 5]

    Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). The total SF-MPQ-2 scale score is calculated as the mean of all 22 items. The range of the total score is 0 to 10.

18. SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Total Score Day 10/Last Visit [Day 0 and Day 10]

    Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). The total SF-MPQ-2 scale score is calculated as the mean of all 22 items. The range of the total score is 0 to 10.

19. Patient Global Impression of Change at End of Study [Day 0 and Day 10/last visit]

    Patient Global Impression of Change (PGIC) assesses the subject's global improvement since starting study treatment using a 7-point NRS (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse).

20. Patient Global Impression of Change at End of Study [Day 0 and Day 10/lst visit]

    Patient Global Impression of Change (PGIC) assesses the subject's global improvement since starting study treatment using a 7-point NRS (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse).

21. Clinician Global Impression of Change at End of Study [Day 0 and Day 10/last visit]

    Clinician Global Impression of Change (CGIC) assesses the subject's global improvement since starting study treatment using a 7-point NRS (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse).

22. Satisfaction With Treatment at Day 5 [Day 0 and Day 5]

    The subject's satisfaction with treatment was assessed using a 7-point scale (1=Very satisfied, 2=Somewhat satisfied, 3=Slightly satisfied, 4=Neither satisfied nor dissatisfied, 5=Slightly dissatisfied, 6=Somewhat dissatisfied, 7=Very dissatisfied).

23. Satisfaction With Treatment at End of Study [Day 0 and Day 10/last visit]

    The subject's satisfaction with treatment was assessed using a 7-point scale (1=Very satisfied, 2=Somewhat satisfied, 3=Slightly satisfied, 4=Neither satisfied nor dissatisfied, 5=Slightly dissatisfied, 6=Somewhat dissatisfied, 7=Very dissatisfied).

24. Incidence of 30% Responders Without Nausea or Vomiting at Day 5 [Day 0 and Day 5]

    Number of subjects had ≥ 30% reduction from baseline in low back pain intensity without nausea or vomiting reported.

25. Incidence of 50% Responders Without Nausea or Vomiting at Day 5 [Day 0 and Day 5]

    Number of subjects had ≥ 50% reduction from baseline in low back pain intensity without nausea or vomiting reported.

26. Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation [Day 0 and Day 10/last visit]

27. Summary of Subjects Having Nausea as a Treatment-Emergent Adverse Event [Day 0 and Day 10/last visit]

    Number of subjects that reported nausea as a treatment-emergent adverse event during the study.

28. Summary of Subjects Having Vomiting as a Treatment-Emergent Adverse Event [Day 0 and Day 10/last visit]

    Number of subjects that reported vomiting as a treatment emergent adverse event during the study.

29. Summary of Subjects Having Constipation as a Treatment-Emergent Adverse Event [Day 0 and Day 10/last visit]

    Number of subjects that reported constipation as a treatment emergent adverse event during the study.

30. Summary of Subjects Having Pruritus as a Treatment-Emergent Adverse Event [Day 0 and Day 10/last visit]

    Number of subjects that reported pruritus as a treatment emergent adverse event during the study.

31. Kaplan-Meier First Time to 30% Response From Baseline for Low Back Pain [Day 0 and Day 10/last visit]

    30% response means >= 30% reduction from baseline in low back pain intensity score.

32. Kaplan-Meier First Time to 50% Response From Baseline for Low Back Pain [Day 0 and Day 10/last visit]

    50% response means >= 50% reduction from baseline in low back pain intensity score.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• At Visit 1 (study entry) patients must have a medical history and physical and neurological examinations that support a clinical diagnosis of acute low back pain that is felt down to the lower leg below the knee with the onset no longer than 30 days before Visit 1

• At Visit 1 patients must report qualifying pain intensity scores

• Patients must be appropriate candidates for treatment with oral opioid pain medication in the investigator's clinical judgment

• Patients must be able to appropriately verbalize pain characteristics and to complete all protocol required measurements/assessments without assistance

• Patients must be medically stable on the basis of physical examination, medical history, vital signs, and clinical laboratory tests performed at screening

Exclusion Criteria:

• History of back (cervical, thoracic or lumbosacral) pain =50% of the time in the 1 year prior to the first visit

• History of any low back pain episode, with the exception of the current acute low back pain episode, within 3 months prior to the first visit that was greater than mild in pain intensity, or was associated with disability (e.g., loss of time from work, family, or activities of daily living), or necessitated the use of an opioid (narcotic) analgesic including tramadol

• Medical history or physical examination results that suggest the acute low back pain or any of the neurological symptoms or signs are caused by a serious medical condition (e.g., fever, chills, unexplained weight loss, bowel or urinary bladder dysfunction or incontinence, bilateral leg weakness, progressive weakness, paralysis)

• There is a high probability for surgical intervention for the back pain during the projected time on the study or that there will be an increase in the severity of the leg pain or deficits

• Had either a surgical procedure involving the spine or intervertebral discs in the lower back region within 1 year prior to Visit 1 or had >1 surgical procedure(s) involving the spine or intervertebral discs in the lower back region

• has any painful condition that could interfere with the study assessments or with the patient's ability to differentiate the pain associated with the acute low back pain episode from pain associated with another condition

• History of severe lumbar spinal stenosis, fibromyalgia, or ankylosing spondylitis

• history of epilepsy or recurrent seizures

• Unable or unwilling to discontinue all prohibited medications at the time of randomization and during the time of their participation in the study

• Known or suspected history of alcohol or drug abuse based on medical history, physical examination, urine drug screening, or the investigator's clinical judgment

• History of cancer malignancy within 2 years prior to the first visit, with the exception of basal cell skin carcinoma

• Have filed or plan to file a worker's compensation claim for any issue related to the current acute low back pain episode

• Currently involved in litigation or plan to seek legal recourse for any issue related to their acute low back pain

• Known allergies, hypersensitivity, or intolerance to tapentadol or the comparator (oxycodone) or any excipients used in their manufacture

• Had previously been enrolled in a tapentadol clinical study

• is pregnant or are breast-feeding

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Mobile	Alabama	United States
2		Phoenix	Arizona	United States
3		Jonesboro	Arkansas	United States
4		Fresno	California	United States
5		Garden Grove	California	United States
6		Glendale	California	United States
7		Laguna Hills	California	United States
8		Palm Springs	California	United States
9		Pismo Beach	California	United States
10		Wildomar	California	United States
11		Denver	Colorado	United States
12		Fairfield	Connecticut	United States
13		Boynton Beach	Florida	United States
14		Clearwater	Florida	United States
15		Edgewater	Florida	United States
16		Jacksonville	Florida	United States
17		Lake Worth	Florida	United States
18		Miami	Florida	United States
19		Newport Richey	Florida	United States
20		Oldsmar	Florida	United States
21		Pembroke Pines	Florida	United States
22		Saint Cloud	Florida	United States
23		Tampa	Florida	United States
24		West Palm Beach	Florida	United States
25		Atlanta	Georgia	United States
26		Savannah	Georgia	United States
27		Avon	Indiana	United States
28		Evansville	Indiana	United States
29		Overland Park	Kansas	United States
30		Lexington	Kentucky	United States
31		Covington	Louisiana	United States
32		Mandeville	Louisiana	United States
33		Metairie	Louisiana	United States
34		New Orleans	Louisiana	United States
35		Sunset	Louisiana	United States
36		Fall River	Massachusetts	United States
37		N Dartmouth	Massachusetts	United States
38		Kalamazoo	Michigan	United States
39		Florissant	Missouri	United States
40		Springfield	Missouri	United States
41		Washington	Missouri	United States
42		Henderson	Nevada	United States
43		Pahrump	Nevada	United States
44		Atco	New Jersey	United States
45		Blackwood	New Jersey	United States
46		Cherry Hill	New Jersey	United States
47		North Massapequa	New York	United States
48		Williamsville	New York	United States
49		Charlotte	North Carolina	United States
50		Hickory	North Carolina	United States
51		Mooresville	North Carolina	United States
52		Winston Salem	North Carolina	United States
53		Akron	Ohio	United States
54		Andover	Ohio	United States
55		Beavercreek	Ohio	United States
56		Centerville	Ohio	United States
57		Cincinnati	Ohio	United States
58		Marion	Ohio	United States
59		Oklahoma City	Oklahoma	United States
60		Altoona	Pennsylvania	United States
61		Tyrone	Pennsylvania	United States
62		Murrells Inlet	South Carolina	United States
63		Nashville	Tennessee	United States
64		Austin	Texas	United States
65		Bryan	Texas	United States
66		Bulverde	Texas	United States
67		Houston	Texas	United States
68		Lake Jackson	Texas	United States
69		Plano	Texas	United States
70		San Antonio	Texas	United States
71		Sugar Land	Texas	United States
72		Clinton	Utah	United States
73		Orem	Utah	United States
74		Danville	Virginia	United States

Sponsors and Collaborators

• Ortho-McNeil Janssen Scientific Affairs, LLC
• Grünenthal GmbH

Investigators

• Study Director: Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial, Ortho-McNeil Janssen Scientific Affairs, LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ortho-McNeil Janssen Scientific Affairs, LLC
• ClinicalTrials.gov Identifier: NCT00986180
• Other Study ID Numbers: CR015643; R331333PAI3025; KF5503/51
• First Posted: Sep 29, 2009
• Last Update Posted: Dec 19, 2012
• Last Verified: Dec 1, 2012

• Keywords provided by Ortho-McNeil Janssen Scientific Affairs, LLC: Acute Low Back Pain; Low Back Pain With Leg Pain Below The Knee; Radiculopathy, Oxycodone; Tapentadol; NUCYNTA
• Additional relevant MeSH terms: Back Pain; Low Back Pain; Oxycodone

Study Results

Participant Flow

Pre-assignment Detail	19 subjects either did not take medication or did not have verifiable drug exposure. 2 subjects were randomized in two different sites, information was included for only one site. 1 subject was randomized in error.

Arm/Group Title	NUCYNTA	Oxycodone IR
Arm/Group Description	50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Period Title: Overall Study
STARTED	321	324
COMPLETED	277	268
NOT COMPLETED	44	56

Baseline Characteristics

Arm/Group Title	NUCYNTA	Oxycodone IR	Total
Arm/Group Description	50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg	Total of all reporting groups
Overall Participants	321	324	645
Age (Count of Participants)
<=18 years	0 0%	1 0.3%	1 0.2%
Between 18 and 65 years	282 87.9%	297 91.7%	579 89.8%
>=65 years	39 12.1%	26 8%	65 10.1%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45.7 (14.18)	45.1 (14.36)	45.4 (14.26)
Sex: Female, Male (Count of Participants)
Female	145 45.2%	176 54.3%	321 49.8%
Male	176 54.8%	148 45.7%	324 50.2%
Region of Enrollment (participants) [Number]
UNITED STATES	321 100%	324 100%	645 100%
Baseline Low Back Pain Intensity (Units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Units on a scale]	7.2 (1.66)	7.2 (1.54)	7.2 (1.60)
Baseline Index Leg Pain Intensity (Units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Units on a scale]	6.2 (2.21)	6.2 (2.10)	6.2 (2.15)
Ethnicity (participants) [Number]
Hispanic or Latino	43 13.4%	39 12%	82 12.7%
Not Hispanic or Latino	278 86.6%	283 87.3%	561 87%
Not Reported	0 0%	2 0.6%	2 0.3%
Baseline BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	30.9 (8.83)	30.4 (8.63)	30.6 (8.72)

Outcome Measures

1. Primary Outcome

Title	Sum of Pain Intensity Difference (SPID) for Low Back Pain - Summary Statistics at 120 Hours (With Imputation)
Description	Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 120 hours.
Time Frame	0 hour (prior to first dose) and 120 hours

Outcome Measure Data

Analysis Population Description

Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).

Arm/Group Title	NUCYNTA	Oxycodone IR
Arm/Group Description	50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Measure Participants	287	298
Least Squares Mean (Standard Error) [Units on a scale]	264.6 (11.43)	264.0 (11.22)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NUCYNTA
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The sample size was recalculated due to Amendment INT-1. The non-inferiority margin for SPID120 was set as 120. The common standard deviation for the SPID120 data was estimated to be 230. Seventy nine subjects in each arm would have 90% power to demonstrate the non-inferiority of NUCYNTA to oxycodone IR with a 1-sided significance level of 0.025. This would have required enrollment of total 158 mITT subjects for each stratum. The original sample size (292 mITT subjects) was derived for SPID72.
Statistical Test of Hypothesis	p-Value	0.9703
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.6
	Confidence Interval	(2-Sided) 95%; -32.1 to 30.9
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 16.02
	Estimation Comments

2. Secondary Outcome

Title	Sum of Pain Intensity Difference (SPID) for Low Back Pain - Summary Statistics at 2 Days (With Imputation)
Description	Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 2 days.
Time Frame	Day 0 and Day 2

Outcome Measure Data

Analysis Population Description

Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).

Arm/Group Title	NUCYNTA	Oxycodone IR
Arm/Group Description	50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Measure Participants	287	298
Least Squares Mean (Standard Error) [Units on a Scale]	80.1 (4.34)	81.8 (4.26)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NUCYNTA, Oxycodone IR
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7691
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.8
	Confidence Interval	(2-Sided) 95%; -10.1 to 13.7
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 6.08
	Estimation Comments

3. Secondary Outcome

Title	SPID for Low Back Pain - Summary Statistics at 3 Days (With Imputation)
Description	Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 3 days.
Time Frame	Day 0 and Day 3

Outcome Measure Data

Analysis Population Description

Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).

Arm/Group Title	NUCYNTA	Oxycodone IR
Arm/Group Description	50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Measure Participants	287	298
Least Squares Mean (Standard Error) [Units on a scale]	137.2 (6.60)	138.1 (6.47)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NUCYNTA, Oxycodone IR
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9282
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.8
	Confidence Interval	(2-Sided) 95%; -17.3 to 19.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 9.24
	Estimation Comments

4. Secondary Outcome

Title	SPID for Low Back Pain - Summary Statistics at 10 Days (With Imputation)
Description	Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 10 days.
Time Frame	Day 0 and Day 10

Outcome Measure Data

Analysis Population Description

Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).

Arm/Group Title	NUCYNTA	Oxycodone IR
Arm/Group Description	50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Measure Participants	287	298
Least Squares Mean (Standard Error) [Units on a scale]	540.2 (21.23)	538.6 (20.84)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NUCYNTA, Oxycodone IR
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9562
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.6
	Confidence Interval	(2-Sided) 95%; -60.1 to 56.8
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 29.75
	Estimation Comments

5. Secondary Outcome

Title	SPID for Index Leg Pain - Summary Statistics at 2 Days (With Imputation)
Description	Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 2 days.
Time Frame	Day 0 and Day 2

Outcome Measure Data

Analysis Population Description

Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).

Arm/Group Title	NUCYNTA	Oxycodone IR
Arm/Group Description	50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Measure Participants	287	298
Least Squares Mean (Standard Error) [Units on a Scale]	73.6 (4.34)	72.1 (4.26)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NUCYNTA, Oxycodone IR
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7973
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.6
	Confidence Interval	(2-Sided) 95%; -13.5 to 10.4
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 6.08
	Estimation Comments

6. Secondary Outcome

Title	SPID for Index Leg Pain - Summary Statistics at 3 Days (With Imputation)
Description	Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 3 days.
Time Frame	Day 0 and Day 3

Outcome Measure Data

Analysis Population Description

Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).

Arm/Group Title	NUCYNTA	Oxycodone IR
Arm/Group Description	50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Measure Participants	287	298
Least Squares Mean (Standard Error) [Units on a Scale]	125.5 (6.63)	123.0 (6.51)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NUCYNTA, Oxycodone IR
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7882
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-2.5
	Confidence Interval	(2-Sided) 95%; -20.8 to 15.8
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 9.30
	Estimation Comments

7. Secondary Outcome

Title	SPID for Index Leg Pain - Summary Statistics at 5 Days (With Imputation)
Description	Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 5 days.
Time Frame	Day 0 and Day 5

Outcome Measure Data

Analysis Population Description

Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).

Arm/Group Title	NUCYNTA	Oxycodone IR
Arm/Group Description	50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Measure Participants	287	298
Least Squares Mean (Standard Error) [Units on a Scale]	239.2 (11.29)	234.1 (11.08)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NUCYNTA, Oxycodone IR
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7491
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-5.1
	Confidence Interval	(2-Sided) 95%; -36.1 to 26.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 15.82
	Estimation Comments

8. Secondary Outcome

Title	SPID for Index Leg Pain - Summary Statistics at 10 Days (With Imputation)
Description	Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 10 days.
Time Frame	Day 0 and Day 10

Outcome Measure Data

Analysis Population Description

Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).

Arm/Group Title	NUCYNTA	Oxycodone IR
Arm/Group Description	50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Measure Participants	287	298
Least Squares Mean (Standard Error) [Units on a Scale]	488.0 (20.71)	476.4 (20.33)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NUCYNTA, Oxycodone IR
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.6897
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-11.6
	Confidence Interval	(2-Sided) 95%; -68.6 to 45.4
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 29.03
	Estimation Comments

9. Secondary Outcome

Title	Total Pain Relief (TOTPAR) for Low Back Pain - Summary Statistics at 5 Days
Description	Pain Relief - 5-Point Numerical Rating Scale, 0=None, 4=Complete. Total Pain Relief (TOTPAR) is a weighted sum of pain relieve over a specified time period, say 5 days.
Time Frame	Day 0 and Day 5

Outcome Measure Data

Analysis Population Description

Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).

Arm/Group Title	NUCYNTA	Oxycodone IR
Arm/Group Description	50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Measure Participants	287	298
Least Squares Mean (Standard Error) [Units on a Scale]	254.8 (5.01)	256.4 (4.91)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NUCYNTA, Oxycodone IR
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8226
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.6
	Confidence Interval	(2-Sided) 95%; -12.2 to 15.4
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 7.02
	Estimation Comments

10. Secondary Outcome

Title	SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Continuous Pain Day 5
Description	Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Continuous pain subscale descriptors include: throbbing pain, cramping pain, gnawing pain, aching pain, heavy pain, and tender.
Time Frame	Day 0 and Day 5

Outcome Measure Data

Analysis Population Description

Intent-To-Treat Population (all randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain) and have both baseline and Day 5 SF-MPQ-2 measurement

Arm/Group Title	NUCYNTA	Oxycodone IR
Arm/Group Description	50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Measure Participants	274	276
Mean (Standard Deviation) [Units on a Scale]	-2.4 (2.05)	-2.4 (2.14)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NUCYNTA
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8880
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

11. Secondary Outcome

Title	SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Continuous Pain Day 10/Last Visit
Description	Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Continuous pain subscale descriptors include: throbbing pain, cramping pain, gnawing pain, aching pain, heavy pain, and tender.
Time Frame	Day 0 and Day 10

Outcome Measure Data

Analysis Population Description

Intent-To-Treat Population and have both baseline and Day 10 SF-MPQ-2 measurements.

Arm/Group Title	NUCYNTA	Oxycodone IR
Arm/Group Description	50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Measure Participants	289	298
Mean (Standard Deviation) [Units on a Scale]	-3.1 (2.35)	-2.9 (2.31)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NUCYNTA
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4115
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

12. Secondary Outcome

Title	SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Intermittent Pain Day 5
Description	Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Intermittent pain subscale descriptors include: shooting pain, stabbing pain, sharp pain, splitting pain, electric-shock pain, and piercing.
Time Frame	Day 0 and Day 5

Outcome Measure Data

Analysis Population Description

Intent-To-Treat Population and have both baseline and Day 5 SF-MPQ-2 measurements.

Arm/Group Title	NUCYNTA	Oxycodone IR
Arm/Group Description	50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Measure Participants	274	276
Mean (Standard Deviation) [Units on a Scale]	-2.6 (2.23)	-2.5 (2.09)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NUCYNTA, Oxycodone IR
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8495
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

13. Secondary Outcome

Title	SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Intermittent Pain Day 10/Last Visit
Description	Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Intermittent pain subscale descriptors include: shooting pain, stabbing pain, sharp pain, splitting pain, electric-shock pain, and piercing.
Time Frame	Day 0 and Day 10

Outcome Measure Data

Analysis Population Description

Intent-To-Treat Population and have both baseline and Day 10 SF-MPQ-2 measurements.

Arm/Group Title	NUCYNTA	Oxycodone IR
Arm/Group Description	50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Measure Participants	289	298
Mean (Standard Deviation) [Units on a Scale]	-3.3 (2.46)	-3.2 (2.29)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NUCYNTA, Oxycodone IR
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7846
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

14. Secondary Outcome

Title	SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Neuropathic Pain Day 5
Description	Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Predominantly neuropathic pain subscale descriptors include: hot-burning pain, cold-freezing pain, pain caused by light touch, itching, tingling or "pins and needles" and numbness.
Time Frame	Day 0 and Day 5

Outcome Measure Data

Analysis Population Description

Intent-To-Treat Population and have both baseline and Day 5 SF-MPQ-2 measurements.

Arm/Group Title	NUCYNTA	Oxycodone IR
Arm/Group Description	50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Measure Participants	274	276
Mean (Standard Deviation) [Units on a Scale]	-1.5 (1.92)	-1.4 (1.85)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NUCYNTA, Oxycodone IR
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4790
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

15. Secondary Outcome

Title	SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Neuropathic Pain Day 10/Last Visit
Description	Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Predominantly neuropathic pain subscale descriptors include: hot-burning pain, cold-freezing pain, pain caused by light touch, itching, tingling or "pins and needles" and numbness.
Time Frame	Day 0 and Day 10

Outcome Measure Data

Analysis Population Description

Intent-To-Treat Population and have both baseline and Day 10 SF-MPQ-2 measurements.

Arm/Group Title	NUCYNTA	Oxycodone IR
Arm/Group Description	50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Measure Participants	289	298
Mean (Standard Deviation) [Units on a Scale]	-1.8 (1.94)	-1.6 (1.99)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NUCYNTA, Oxycodone IR
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.3147
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

16. Secondary Outcome

Title	SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Affective Descriptors Day 5
Description	Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Affective subscale descriptors include: tiring-exhausting, sickening, fearful, and punishing-cruel.
Time Frame	Day 0 and Day 5

Outcome Measure Data

Analysis Population Description

Intent-To-Treat Population and have both baseline and Day 5 SF-MPQ-2 measurements.

Arm/Group Title	NUCYNTA	Oxycodone IR
Arm/Group Description	50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Measure Participants	274	276
Mean (Standard Deviation) [score of scale]	-2.0 (2.46)	-1.9 (2.31)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NUCYNTA, Oxycodone IR
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.5411
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

17. Secondary Outcome

Title	SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Affective Descriptors Day 10/Last Visit
Description	Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Affective subscale descriptors include: tiring-exhausting, sickening, fearful, and punishing-cruel.
Time Frame	Day 0 and Day 10

Outcome Measure Data

Analysis Population Description

Intent-To-Treat Population and have both baseline and Day 10 SF-MPQ-2 measurements.

Arm/Group Title	NUCYNTA	Oxycodone IR
Arm/Group Description	50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Measure Participants	289	298
Mean (Standard Deviation) [Units on a Scale]	-2.4 (2.74)	-2.2 (2.39)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NUCYNTA, Oxycodone IR
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.6137
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

18. Secondary Outcome

Title	SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Total Score Day 5
Description	Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). The total SF-MPQ-2 scale score is calculated as the mean of all 22 items. The range of the total score is 0 to 10.
Time Frame	Day 0 and Day 5

Outcome Measure Data

Analysis Population Description

Intent-To-Treat Population and have both baseline and Day 5 SF-MPQ-2 measurements.

Arm/Group Title	NUCYNTA	Oxycodone IR
Arm/Group Description	50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Measure Participants	275	277
Mean (Standard Deviation) [Units on a Scale]	-2.2 (1.84)	-2.1 (1.74)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NUCYNTA, Oxycodone IR
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7246
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

19. Secondary Outcome

Title	SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Total Score Day 10/Last Visit
Description	Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). The total SF-MPQ-2 scale score is calculated as the mean of all 22 items. The range of the total score is 0 to 10.
Time Frame	Day 0 and Day 10

Outcome Measure Data

Analysis Population Description

Intent-To-Treat Population with both baseline and Day 10 SF-MPQ-2 measurements.

Arm/Group Title	NUCYNTA	Oxycodone IR
Arm/Group Description	50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Measure Participants	290	298
Mean (Standard Deviation) [Units on a Scale]	-2.7 (2.04)	-2.5 (1.91)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NUCYNTA, Oxycodone IR
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4882
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

20. Secondary Outcome

Title	Patient Global Impression of Change at End of Study
Description	Patient Global Impression of Change (PGIC) assesses the subject's global improvement since starting study treatment using a 7-point NRS (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse).
Time Frame	Day 0 and Day 10/last visit

Outcome Measure Data

Analysis Population Description

Intent-To-Treat Population.

Arm/Group Title	NUCYNTA	Oxycodone IR
Arm/Group Description	50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Measure Participants	302	311
1 = Very much improved	89	90
2 = Much improved	111	116
3 = Minimally improved	59	67
4 = No change	27	24
5 = Minimally worse	2	0
6 = Much worse	1	0
7 = Very much worse	1	1
Missing	12	13

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NUCYNTA, Oxycodone IR
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7201
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

21. Secondary Outcome

Title	Patient Global Impression of Change at End of Study
Description	Patient Global Impression of Change (PGIC) assesses the subject's global improvement since starting study treatment using a 7-point NRS (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse).
Time Frame	Day 0 and Day 10/lst visit

Outcome Measure Data

Analysis Population Description

Intent-To-Treat Population with PGIC assessment.

Arm/Group Title	NUCYNTA	Oxycodone IR
Arm/Group Description	50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Measure Participants	290	298
Mean (Standard Deviation) [Units on a Scale]	2.1 (1.04)	2.1 (0.96)

22. Secondary Outcome

Title	Clinician Global Impression of Change at End of Study
Description	Clinician Global Impression of Change (CGIC) assesses the subject's global improvement since starting study treatment using a 7-point NRS (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse).
Time Frame	Day 0 and Day 10/last visit

Outcome Measure Data

Analysis Population Description

Intent-To-Treat Population.

Arm/Group Title	NUCYNTA	Oxycodone IR
Arm/Group Description	50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Measure Participants	302	311
1 = Very much improved	78	77
2 = Much improved	127	130
3 = Minimally improved	60	70
4 = No change	21	18
5 = Minimally worse	2	1
6 = Much worse	1	0
7 = Very much worse	2	0
Missing	12	13

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NUCYNTA, Oxycodone IR
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.5208
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

23. Secondary Outcome

Title	Clinician Global Impression of Change at End of Study
Description	Clinician Global Impression of Change (CGIC) assesses the subject's global improvement since starting study treatment using a 7-point NRS (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse).
Time Frame	Day 0 and Day 10/last visit

Outcome Measure Data

Analysis Population Description

Intent-To-Treat Population with CGIC assessment.

Arm/Group Title	NUCYNTA	Oxycodone IR
Arm/Group Description	50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Measure Participants	290	298
Mean (Standard Deviation) [Units on a Scale]	2.1 (0.99)	2.1 (0.93)

24. Secondary Outcome

Title	Satisfaction With Treatment at Day 5
Description	The subject's satisfaction with treatment was assessed using a 7-point scale (1=Very satisfied, 2=Somewhat satisfied, 3=Slightly satisfied, 4=Neither satisfied nor dissatisfied, 5=Slightly dissatisfied, 6=Somewhat dissatisfied, 7=Very dissatisfied).
Time Frame	Day 0 and Day 5

Outcome Measure Data

Analysis Population Description

Intent-To-Treat Population.

Arm/Group Title	NUCYNTA	Oxycodone IR
Arm/Group Description	50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Measure Participants	302	311
1 = Very satisfied	113	92
2 = Somewhat satisfied	102	132
3 = Slightly satisfied	31	32
4 = Neither satisfied nor dissatisfied	16	5
5 = Slightly dissatisfied	8	7
6 = Somewhat dissatisfied	2	5
7 = Very dissatisfied	3	4
Missing	27	34

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NUCYNTA, Oxycodone IR
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0401
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

25. Secondary Outcome

Title	Satisfaction With Treatment at Day 5
Description	The subject's satisfaction with treatment was assessed using a 7-point scale (1=Very satisfied, 2=Somewhat satisfied, 3=Slightly satisfied, 4=Neither satisfied nor dissatisfied, 5=Slightly dissatisfied, 6=Somewhat dissatisfied, 7=Very dissatisfied).
Time Frame	Day 0 and Day 5

Outcome Measure Data

Analysis Population Description

Intent-To-Treat Population with subject's satisfaction assessment on Day 5.

Arm/Group Title	NUCYNTA	Oxycodone IR
Arm/Group Description	50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Measure Participants	275	277
Mean (Standard Deviation) [Units on a Scale]	2.0 (1.19)	2.0 (1.18)

26. Secondary Outcome

Title	Satisfaction With Treatment at End of Study
Description	The subject's satisfaction with treatment was assessed using a 7-point scale (1=Very satisfied, 2=Somewhat satisfied, 3=Slightly satisfied, 4=Neither satisfied nor dissatisfied, 5=Slightly dissatisfied, 6=Somewhat dissatisfied, 7=Very dissatisfied).
Time Frame	Day 0 and Day 10/last visit

Outcome Measure Data

Analysis Population Description

Intent-To-Treat Population.

Arm/Group Title	NUCYNTA	Oxycodone IR
Arm/Group Description	50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Measure Participants	302	311
1 = Very satisfied	146	148
2 = Somewhat satisfied	84	87
3 = Slightly satisfied	28	29
4 = Neither satisfied nor dissatisfied	7	14
5 = Slightly dissatisfied	7	3
6 = Somewhat dissatisfied	8	4
7 = Very dissatisfied	10	13
Missing	12	13

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NUCYNTA, Oxycodone IR
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4679
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

27. Secondary Outcome

Title	Satisfaction With Treatment at End of Study
Description	The subject's satisfaction with treatment was assessed using a 7-point scale (1=Very satisfied, 2=Somewhat satisfied, 3=Slightly satisfied, 4=Neither satisfied nor dissatisfied, 5=Slightly dissatisfied, 6=Somewhat dissatisfied, 7=Very dissatisfied).
Time Frame	Day 0 and Day 10/last visit

Outcome Measure Data

Analysis Population Description

Intent-To-Treat Population with subject's satisfaction assessment at end of the study.

Arm/Group Title	NUCYNTA	Oxycodone IR
Arm/Group Description	50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Measure Participants	290	298
Mean (Standard Deviation) [Units on a Scale]	2.0 (1.49)	2.0 (1.48)

28. Secondary Outcome

Title	Incidence of 30% Responders Without Nausea or Vomiting at Day 5
Description	Number of subjects had ≥ 30% reduction from baseline in low back pain intensity without nausea or vomiting reported.
Time Frame	Day 0 and Day 5

Outcome Measure Data

Analysis Population Description

Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).

Arm/Group Title	NUCYNTA	Oxycodone IR
Arm/Group Description	50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Measure Participants	287	298
Number [Participants]	117 36.4%	104 32.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NUCYNTA, Oxycodone IR
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1454
	Comments
	Method	Fisher Exact
	Comments

29. Secondary Outcome

Title	Incidence of 50% Responders Without Nausea or Vomiting at Day 5
Description	Number of subjects had ≥ 50% reduction from baseline in low back pain intensity without nausea or vomiting reported.
Time Frame	Day 0 and Day 5

Outcome Measure Data

Analysis Population Description

Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).

Arm/Group Title	NUCYNTA	Oxycodone IR
Arm/Group Description	50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Measure Participants	287	298
Number [Participants]	72 22.4%	60 18.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NUCYNTA, Oxycodone IR
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1541
	Comments
	Method	Fisher Exact
	Comments

30. Secondary Outcome

Title	Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation
Time Frame	Day 0 and Day 10/last visit

Outcome Measure Data

Analysis Population Description

Safety Population: all randomized subjects who take at least 1 dose of study drug.

Arm/Group Title	NUCYNTA	Oxycodone IR
Arm/Group Description	50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Measure Participants	321	324
Number of subjects with adverse events	21 6.5%	26 8%
Eye disorders	1 0.3%	0 0%
Vision blurred	1 0.3%	0 0%
Gastrointestinal disorders	11 3.4%	14 4.3%
Nausea	6 1.9%	9 2.8%
Vomiting	5 1.6%	6 1.9%
Diarrhea	1 0.3%	1 0.3%
Abdominal discomfort	1 0.3%	0 0%
Constipation	0 0%	1 0.3%
General disorders and admin. site conditions	2 0.6%	0 0%
Fatigue	2 0.6%	0 0%
Infections and infestations	0 0%	1 0.3%
Upper respiratory tract infection	0 0%	1 0.3%
Injury, poisoning and procedural complications	0 0%	1 0.3%
Contusion	0 0%	1 0.3%
Investigations	1 0.3%	1 0.3%
Hepatic enzyme increased	1 0.3%	0 0%
Liver function test abnormal	0 0%	1 0.3%
Musculoskeletal and connective tissue disorders	2 0.6%	1 0.3%
Back pain	1 0.3%	1 0.3%
Muscle spasms	1 0.3%	0 0%
Neoplasms benign, malignant and unspecified	1 0.3%	0 0%
Lung cancer metastatic	1 0.3%	0 0%
Nervous system disorders	6 1.9%	9 2.8%
Dizziness	3 0.9%	3 0.9%
Somnolence	2 0.6%	2 0.6%
Headache	1 0.3%	2 0.6%
Convulsion	0 0%	1 0.3%
Syncope	0 0%	1 0.3%
Psychiatric disorders	0 0%	1 0.3%
Depression	0 0%	1 0.3%
Skin and subcutaneous tissue disorders	1 0.3%	3 0.9%
Rash	0 0%	2 0.6%
Pruritus	0 0%	1 0.3%
Rash generalized	1 0.3%	0 0%

31. Secondary Outcome

Title	Summary of Subjects Having Nausea as a Treatment-Emergent Adverse Event
Description	Number of subjects that reported nausea as a treatment-emergent adverse event during the study.
Time Frame	Day 0 and Day 10/last visit

Outcome Measure Data

Analysis Population Description

Safety Population: all randomized subjects who take at least 1 dose of study drug.

Arm/Group Title	NUCYNTA	Oxycodone IR
Arm/Group Description	50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Measure Participants	321	324
Number [Participants]	51 15.9%	67 20.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NUCYNTA
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.38
	Confidence Interval	(2-Sided) 95%; 0.92 to 2.06
	Parameter Dispersion	Type: Value:
	Estimation Comments

32. Secondary Outcome

Title	Summary of Subjects Having Vomiting as a Treatment-Emergent Adverse Event
Description	Number of subjects that reported vomiting as a treatment emergent adverse event during the study.
Time Frame	Day 0 and Day 10/last visit

Outcome Measure Data

Analysis Population Description

Safety Population: all randomized subjects who take at least 1 dose of study drug.

Arm/Group Title	NUCYNTA	Oxycodone IR
Arm/Group Description	50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Measure Participants	321	324
Number [Participants]	51 15.9%	80 24.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NUCYNTA
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.74
	Confidence Interval	(2-Sided) 95%; 1.17 to 2.57
	Parameter Dispersion	Type: Value:
	Estimation Comments

33. Secondary Outcome

Title	Summary of Subjects Having Constipation as a Treatment-Emergent Adverse Event
Description	Number of subjects that reported constipation as a treatment emergent adverse event during the study.
Time Frame	Day 0 and Day 10/last visit

Outcome Measure Data

Analysis Population Description

Safety Population: all randomized subjects who take at least 1 dose of study drug.

Arm/Group Title	NUCYNTA	Oxycodone IR
Arm/Group Description	50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Measure Participants	321	324
Number [Participants]	7 2.2%	23 7.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NUCYNTA, Oxycodone IR
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	3.43
	Confidence Interval	(2-Sided) 95%; 1.45 to 8.11
	Parameter Dispersion	Type: Value:
	Estimation Comments

34. Secondary Outcome

Title	Summary of Subjects Having Pruritus as a Treatment-Emergent Adverse Event
Description	Number of subjects that reported pruritus as a treatment emergent adverse event during the study.
Time Frame	Day 0 and Day 10/last visit

Outcome Measure Data

Analysis Population Description

Safety Population: all randomized subjects who take at least 1 dose of study drug.

Arm/Group Title	NUCYNTA	Oxycodone IR
Arm/Group Description	50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Measure Participants	321	324
Number [Participants]	27 8.4%	26 8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NUCYNTA, Oxycodone IR
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.95
	Confidence Interval	(2-Sided) 95%; 0.54 to 1.67
	Parameter Dispersion	Type: Value:
	Estimation Comments

35. Secondary Outcome

Title	Kaplan-Meier First Time to 30% Response From Baseline for Low Back Pain
Description	30% response means >= 30% reduction from baseline in low back pain intensity score.
Time Frame	Day 0 and Day 10/last visit

Outcome Measure Data

Analysis Population Description

Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).

Arm/Group Title	NUCYNTA	Oxycodone IR
Arm/Group Description	50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Measure Participants	287	298
Median (95% Confidence Interval) [Hours]	42.93	44.27

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NUCYNTA, Oxycodone IR
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.5828
	Comments
	Method	Log Rank
	Comments

36. Secondary Outcome

Title	Kaplan-Meier First Time to 50% Response From Baseline for Low Back Pain
Description	50% response means >= 50% reduction from baseline in low back pain intensity score.
Time Frame	Day 0 and Day 10/last visit

Outcome Measure Data

Analysis Population Description

Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).

Arm/Group Title	NUCYNTA	Oxycodone IR
Arm/Group Description	50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Measure Participants	287	298
Median (95% Confidence Interval) [Hours]	92.05	107.45

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NUCYNTA
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9084
	Comments
	Method	Log Rank
	Comments

Adverse Events

Arm/Group Title	NUCYNTA		Oxycodone IR
Arm/Group Description	50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg		5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
All Cause Mortality
	NUCYNTA		Oxycodone IR
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	NUCYNTA		Oxycodone IR
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/321 (0.6%)		3/324 (0.9%)
Musculoskeletal and connective tissue disorders
Back Pain	1/321 (0.3%)		0/324 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Cancer Metastatic	1/321 (0.3%)		0/324 (0%)
Nervous system disorders
Convulsion	0/321 (0%)		1/324 (0.3%)
Syncope	0/321 (0%)		1/324 (0.3%)
Psychiatric disorders
Anxiety	0/321 (0%)		1/324 (0.3%)
Other (Not Including Serious) Adverse Events
	NUCYNTA		Oxycodone IR
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	141/321 (43.9%)		165/324 (50.9%)
Gastrointestinal disorders
Nausea	51/321 (15.9%)		67/324 (20.7%)
Vomiting	51/321 (15.9%)		80/324 (24.7%)
Constipation	7/321 (2.2%)		23/324 (7.1%)
Nervous system disorders
Dizziness	38/321 (11.8%)		34/324 (10.5%)
Somnolence	26/321 (8.1%)		22/324 (6.8%)
Headache	14/321 (4.4%)		20/324 (6.2%)
Skin and subcutaneous tissue disorders
Pruritus	27/321 (8.4%)		26/324 (8%)

Limitations/Caveats

There were 19 subjects either did not take medication or did not have verifiable drug exposure. 2 subjects were randomized in two different sites, only one site information were included. 1 subject were randomized in error.

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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.