RN624 In Adult Patients With Chronic Low Back Pain
Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00584870
Collaborator
(none)
220
38
3
14
5.8
0.4
Study Details
Study Description
Brief Summary
The primary objective of this study is to evaluate the analgesic efficacy of RN624 compared with placebo and compared with naproxen in the treatment of adult patients with chronic low back pain.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
220 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
PHASE II RANDOMIZED, DOUBLE-BLIND, PLACEBO-AND ACTIVE CONTROLLED, MULTICENTER, PARALLEL GROUP PROOF OF CONCEPT STUDY OF THE ANALGESIC EFFECTS OF RN624 IN ADULT PATIENTS WITH CHRONIC LOW BACK PAIN
Actual Study Start Date
:
Jul 5, 2007
Actual Primary Completion Date
:
Sep 2, 2008
Actual Study Completion Date
:
Sep 2, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Naproxen
|
Drug: Naproxen
Oral naproxen 500 mg twice daily for Weeks 1-12.
|
| Placebo Comparator: Placebo
|
Drug: Placebo
Single IV infusion of placebo on Day 1 and placebo for naproxen twice daily for Weeks 1-12.
|
| Experimental: RN624
|
Drug: PF-04383119 (RN624)
Single IV infusion of 200 micrograms/kg RN624 on Day 1
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 6 [Baseline, Week 6]
Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain). Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week.
Secondary Outcome Measures
- Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 1, 2, 4, 8 and 12 [Baseline, Week 1, 2, 4, 8, 12]
Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), with lower scores indicating less pain. Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week.
- Change From Baseline in Average Low Back Pain Intensity (LBPI) Score Over Weeks 1 to 4, 1 to 8, 1 to 12, 5 to 8, and 5 to 12 [Baseline, Weeks 1 to 4, 1 to 8, 1 to 12, 5 to 8, 5 to 12]
Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), with lower scores indicating less pain. Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week. Change from baseline was calculated as the average of each specified week interval (Week 1 to 4, 1 to 8, 1 to 12, 5 to 8, 5 to 12) values minus the baseline value.
- Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 [Baseline, Week 1, 2, 4, 6, 8, 12]
The mBPI-sf was a self-administered questionnaire used to assess the severity of pain and the impact of pain on daily functions during the 24-hour period prior to evaluation. It consisted of 5 questions. Questions (Q) 1-4 assessed the magnitude of pain (Q1 for worst pain, Q2 for least pain, Q3 for average pain, Q4 for pain right now) on an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine), with lower scores indicating less pain. Question 5 consisted of 7 sub-items (A to G; general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life) which measured the level of interference of pain on daily functions. Each sub-item was assessed on an 11-point NRS ranging from 0 (does not interfere) to 10 (completely interferes). Results are reported for worst and average pain score, each ranging from 0 (no pain) to 10 (pain as bad as you can imagine), with lower scores indicating less pain.
- Number of Participants With Average Low Back Pain Intensity (LBPI) Score of 2 or Less [Week 1, 2, 4, 6, 8, 12]
Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), with lower scores indicating less pain. Weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week. Participants were classified as responders if average LBPI score was 2 or less, and as non-responders if average LBPI score was greater than (>) 2. Participants with average LBPI score of 2 or less were reported.
- Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6 [Week 6]
Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), with lower scores indicating less pain. Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week. Number of participants with cumulative reduction (as percent) (greater than 0% ; >= 10, 20, 30, 40, 50, 60, 70, 80 and 90%; = 100 %) in Average LBPI score from Baseline at Week 6 were reported, participants (%) are reported more than once in categories specified.
- Number of Participants With at Least 30% and 50% Sustained Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score [Week 12]
Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week. Participants with >=30% or >=50% reduction from baseline in daily average LBPI score that was maintained for a minimum duration of 4 consecutive days were reported.
- Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score [Weeks 1, 2, 4, 6, 8, 12]
Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), with lower scores indicating less pain. Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week. Number of participants with >=30% and >=50% reduction from Baseline in daily average LBPI score were reported.
- Time to Achieve at Least 30% and 50% Sustained Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score [Randomization to Last Study Visit (up to 16 weeks)]
Time to achieve >=30% or >=50% sustained reduction from baseline (i.e. reduction from baseline in daily average LBPI score that was maintained for a total of 4 consecutive days) was summarized using the Kaplan-Meier estimates of the median time to 30% and 50% response. Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), with lower scores indicating less pain. Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week.
- Total Duration of at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score [Week 1 up to Week 12]
Total duration of response was defined as the total number of days with >=30% or >=50% reduction from baseline in the daily average LBPI score. Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), with lower scores indicating less pain. Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week.
- Change From Baseline in Roland-Morris Disability Questionnaire Total Score at Week 1, 2, 4, 6, 8, and 12 [Baseline, Week 1, 2, 4, 6, 8, 12]
Roland-Morris Disability Questionnaire: low back pain-specific, participant administered questionnaire that assessed how well participants with low back pain were able to function with regard to daily activities. The questionnaire consisted of 24 statements and the participants were instructed to put a mark next to each appropriate statement if it described their pain on the day of assessment. The number of statements marked were added up by the clinician. Total RMDQ score was calculated as the sum of number of statements checked. Total possible score ranged from 0 to 24, with higher scores indicated greater disability.
- Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 [Baseline, Week 1, 2, 4, 6, 8, 12]
The mBPI-sf was a self-administered questionnaire used to assess the severity of pain and the impact of pain on daily functions during the 24-hour period prior to evaluation. It consisted of 5 questions. Questions 1 to 4 assessed the magnitude of pain (worst, least, average, right now) on an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). Question 5 consisted of 7 sub-items (general activity [GA], mood, walking ability [WA], normal work [NW], relations with other people, sleep, enjoyment of life) which measured the level of interference of pain on daily functions. Each sub-item was assessed on an 11-point NRS ranging from 0 (did not interfere) to 10 (completely interfere). The response from 7 sub-items of question 5 were averaged to obtain pain interference composite score (CS), range: 0 to 10 (higher score=more interference).
- Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 [Week 1, 2, 4, 6, 8, 12]
Patient's global assessment of low back pain scale assessed participants overall impression of disease activity. Participants answered: "Considering all the ways your low back pain affects you, how are you doing today?" Participants responded using 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). Participants who reported a change of -4, -3, -2, -1, 0, 1, 2, 3, 4 from Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) score at specified weeks were presented.
- Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication [Week 1, 2, 4, 6, 8, 12]
Participants answered: "In all ways, how would you rate your overall response to the study medication today?" Participants responded using a 4-point Likert scale where 1 = poor, 2 = fair, 3 = good and 4 = excellent. Higher score indicated better overall response to the treatment.
- Number of Participants Who Discontinued the Study Due to Lack of Efficacy [Baseline up to Week 12]
- Time to Discontinuation Due to Lack of Efficacy [Baseline up to Week 12]
Median time to discontinuation due to lack of efficacy was estimated using Kaplan-Meier method. Median was not estimable if the percentage of participants who discontinued due to lack of efficacy was below 50%.
- Number of Participants With Chronic Low Back Pain (CLBP) Response [Weeks 1, 2, 4, 6, 8, 12]
Participants were considered as CLBP responders if they had achieved a reduction of >=30% in daily average LBPI score from baseline, an increase of >=30% in patient's global assessment of low back pain (disease activity) from baseline, and no worsening (increase) in RMDQ total score from baseline at specified week. Daily average low back pain assessed on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain). Patient's global assessment of low back pain assessed using 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). RMDQ: low back pain-specific, participant administered questionnaire consisted of 24 statements and participants were instructed to put a mark next to each appropriate statement if it described their pain on the day of assessment. Total RMDQ score was calculated as sum of number of statements checked. Total possible score ranged from 0 to 24, with higher scores indicated greater disability.
- Number of Participants Who Used Rescue Medications [Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12]
In case of inadequate pain relief for CLBP or for non-CLBP related pain, acetaminophen up to 2000 mg per day up to 3 days per week could be taken as rescue medication. Number of participants with any use of rescue medication during the particular study week were summarized.
- Duration of Rescue Medication Use [Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12]
In case of inadequate pain relief for CLBP or for non-CLBP related pain, acetaminophen up to 2000 mg per day up to 3 days per week could be taken as rescue medication. The number of days of rescue medication use during the particular week were summarized.
- Amount of Rescue Medication Taken [Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12]
In case of inadequate pain relief for CLBP or for non-CLBP related pain, acetaminophen up to 2000 mg per day up to 3 days per week could be taken as rescue medication. The total dosage of acetaminophen (in mg) in each particular week was summarized.
Other Outcome Measures
- Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [Baseline up to 28 days after last dose of study treatment (up to Week 16)]
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose (up to Week 16) that were absent before treatment or that worsened relative to pretreatment state.
- Number of Participants With Anti-Drug Antibody (ADA) [Baseline up to Week 12]
Human serum anti-drug antibody (ADA) samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA).
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Male or female of any race, >18 years of age and have BMI ≤39 kg/m2
-
Present with duration of chronic low back pain of ≥3 months requiring regular use of analgesic medication (>4 days per week for the past month)
-
Primary location of low back pain is between the 12th thoracic vertebra and the lower gluteal folds, with or without radiation into the posterior thigh, classified as Category 1 or 2 according to the classification of the Quebec Task Force in Spinal Disorders
-
Must have a score of ≥4 for Low Back Pain Intensity (NRS) while on current treatment at Screening, and completes at least 4 daily pain diaries during the 5 days prior to Randomization, with an average Low Back Pain Intensity (NRS) score of ≥4
Exclusion Criteria:
-
Back pain due to visceral disorder (i.e. endometriosis) or Back pain due to recent major trauma (i.e. vertebral fracture, post-traumatic spondylolisthesis)
-
History of lumbosacral radiculopathy, spinal stenosis associated with neurological impairment, or neurogenic claudication
-
Osteoporotic compression fracture within the last 6 months
-
Known history of: Rheumatoid arthritis; Seronegative spondyloarthropathy (i.e., ankylosing spondylitis, psoriatic arthritis, reactive arthritis, inflammatory bowel disease-related arthropathy); Paget's disease of spine, pelvis or femur; Fibromyalgia; Tumors or infections of the spinal cord
-
Patients receiving acetaminophen only to manage their chronic low back pain
-
Any uncontrolled or untreated chronic disease
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pinnacle Research Group LLC | Anniston | Alabama | United States | 36207 |
| 2 | Radiant Research | Birmingham | Alabama | United States | 35209 |
| 3 | Radiant Research - Phoenix Southeast | Chandler | Arizona | United States | 85225 |
| 4 | Radiant Research | Scottsdale | Arizona | United States | 85251 |
| 5 | Advanced Clinical Research Institute | Anaheim | California | United States | 92801 |
| 6 | University of California San Diego | San Diego | California | United States | 92121 |
| 7 | Doctors Medical Center of Walton County | DeFuniak Springs | Florida | United States | 32435 |
| 8 | SJS Clinical Research, Inc. | Destin | Florida | United States | 32541 |
| 9 | Adult Medicine Specialists | Longwood | Florida | United States | 32779 |
| 10 | Genesis Research International | Longwood | Florida | United States | 32779 |
| 11 | Collier Neurologic Specialists | Naples | Florida | United States | 34102 |
| 12 | Cotton-O'Neil Clinical Research | Topeka | Kansas | United States | 66606 |
| 13 | Cotton-O'Neil Clinic | Topeka | Kansas | United States | 66606 |
| 14 | Heartland Research Associates | Wichita | Kansas | United States | 67207 |
| 15 | Northeast Medical Research Associates, Inc | North Dartmouth | Massachusetts | United States | 02747 |
| 16 | Clinical Pharmacology Study Group | Worcester | Massachusetts | United States | 01610 |
| 17 | Spence Medical Research | Picayune | Mississippi | United States | 39466 |
| 18 | Radiant Research, Inc. | Saint Louis | Missouri | United States | 63141 |
| 19 | Quality Clinical Research, Inc. | Omaha | Nebraska | United States | 68114 |
| 20 | The Medical Research Network, LLC | New York | New York | United States | 10024 |
| 21 | North State Clinical Research, PLLC | Lenoir | North Carolina | United States | 28645 |
| 22 | Wake Internal Medicine Consultants, Inc. | Raleigh | North Carolina | United States | 27612 |
| 23 | Wake Research Associates | Raleigh | North Carolina | United States | 27612 |
| 24 | Summit Research Network (Oregon), Inc. | Portland | Oregon | United States | 97210 |
| 25 | Allegheny Pain Management | Altoona | Pennsylvania | United States | 16602 |
| 26 | New England Center for Clinical Research | Cranston | Rhode Island | United States | 02920 |
| 27 | Partners in Clinical Research | Cumberland | Rhode Island | United States | 02864 |
| 28 | Omega Medical Research | Warwick | Rhode Island | United States | 02886 |
| 29 | Radiant Research | Greer | South Carolina | United States | 29651 |
| 30 | Advanced Therapeutics, Inc. | Johnson City | Tennessee | United States | 37601 |
| 31 | Johnson City Internal Medicine | Johnson City | Tennessee | United States | 37601 |
| 32 | DiscoveResearch, Incorporated | Bryan | Texas | United States | 77802 |
| 33 | Advances In Health, Inc. | Houston | Texas | United States | 77030 |
| 34 | Centex Research | Nassau Bay | Texas | United States | 77058 |
| 35 | Immediate Medical Care | Nassau Bay | Texas | United States | 77058 |
| 36 | Radiant Research San Antonio | San Antonio | Texas | United States | 78229 |
| 37 | Independence Family Medicine | Virginia Beach | Virginia | United States | 23455 |
| 38 | Summit Research Network (Seattle) LLC | Seattle | Washington | United States | 98104 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT00584870
Other Study ID Numbers:
- A4091004
- CLBP POC
First Posted:
Jan 2, 2008
Last Update Posted:
Jul 12, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | Participants underwent a 5-day initial pain assessment period prior to study treatment. |
| Arm/Group Title | Tanezumab | Naproxen | Placebo |
|---|---|---|---|
| Arm/Group Description | Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12. | Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12. | Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12. |
| Period Title: Overall Study | |||
| STARTED | 88 | 89 | 43 |
| Treated | 88 | 88 | 41 |
| COMPLETED | 59 | 64 | 25 |
| NOT COMPLETED | 29 | 25 | 18 |
Baseline Characteristics
| Arm/Group Title | Tanezumab | Naproxen | Placebo | Total |
|---|---|---|---|---|
| Arm/Group Description | Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12. | Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12. | Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12. | Total of all reporting groups |
| Overall Participants | 88 | 88 | 41 | 217 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
49.5
(14.7)
|
52.1
(14.8)
|
52.2
(15)
|
51.1
(14.8)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
53
60.2%
|
42
47.7%
|
23
56.1%
|
118
54.4%
|
| Male |
35
39.8%
|
46
52.3%
|
18
43.9%
|
99
45.6%
|
Outcome Measures
| Title | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 6 |
|---|---|
| Description | Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain). Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week. |
| Time Frame | Baseline, Week 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo infusion). Here 'number analyzed' signifies participants who were evaluable for this measure at given time points. |
| Arm/Group Title | Tanezumab | Naproxen | Placebo |
|---|---|---|---|
| Arm/Group Description | Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12. | Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12. | Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12. |
| Measure Participants | 88 | 88 | 41 |
| Baseline |
6.48
(1.42)
|
6.65
(1.44)
|
6.67
(1.44)
|
| Change at Week 6 |
-3.58
(1.87)
|
-2.69
(1.98)
|
-2.16
(2.24)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab, Placebo |
|---|---|---|
| Comments | LS mean difference was estimated from the repeated measures model with baseline, center, treatment, week and treatment-by-week interaction as fixed main effects and participant as random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | p-value was based on repeated measures model from pairwise comparisons, and statistical test was 1-sided with 0.1 significance level. | |
| Method | Repeated Measures Model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least squares (LS) Mean Difference |
| Estimated Value | -1.17 | |
| Confidence Interval |
(2-Sided) 80% -1.67 to -0.67 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.39 |
|
| Estimation Comments | ||
| Title | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 1, 2, 4, 8 and 12 |
|---|---|
| Description | Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), with lower scores indicating less pain. Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week. |
| Time Frame | Baseline, Week 1, 2, 4, 8, 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo infusion). Here "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure and 'number analyzed' signifies those participants who were evaluable for this measure at given time points. |
| Arm/Group Title | Tanezumab | Naproxen | Placebo |
|---|---|---|---|
| Arm/Group Description | Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12. | Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12. | Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12. |
| Measure Participants | 88 | 87 | 40 |
| Change at Week 1 |
-2.41
(1.69)
|
-2.18
(1.81)
|
-1.34
(1.52)
|
| Change at Week 2 |
-2.25
(2.04)
|
-2.40
(1.83)
|
-1.92
(1.87)
|
| Change at Week 4 |
-3.39
(1.83)
|
-2.57
(1.86)
|
-2.23
(2.07)
|
| Change at Week 8 |
-3.74
(1.88)
|
-2.79
(2.06)
|
-2.48
(2.09)
|
| Change at Week 12 |
-3.45
(2.08)
|
-2.88
(2.24)
|
-2.68
(2.40)
|
| Title | Change From Baseline in Average Low Back Pain Intensity (LBPI) Score Over Weeks 1 to 4, 1 to 8, 1 to 12, 5 to 8, and 5 to 12 |
|---|---|
| Description | Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), with lower scores indicating less pain. Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week. Change from baseline was calculated as the average of each specified week interval (Week 1 to 4, 1 to 8, 1 to 12, 5 to 8, 5 to 12) values minus the baseline value. |
| Time Frame | Baseline, Weeks 1 to 4, 1 to 8, 1 to 12, 5 to 8, 5 to 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo infusion). Here "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure and 'number analyzed' signifies those participants who were evaluable for this measure at given time points. |
| Arm/Group Title | Tanezumab | Naproxen | Placebo |
|---|---|---|---|
| Arm/Group Description | Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12. | Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12. | Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12. |
| Measure Participants | 88 | 87 | 41 |
| Change over Weeks 1 to 4 |
-2.59
(1.75)
|
-2.35
(1.73)
|
-1.83
(1.71)
|
| Change over Weeks 1 to 8 |
-2.86
(1.81)
|
-2.47
(1.75)
|
-1.97
(1.80)
|
| Change over Weeks 1 to 12 |
-2.92
(1.85)
|
-2.52
(1.80)
|
-2.06
(1.84)
|
| Change over Weeks 5 to 8 |
-3.56
(1.91)
|
-2.66
(1.89)
|
-2.38
(2.07)
|
| Change over Weeks 5 to 12 |
-3.48
(1.94)
|
-2.68
(1.94)
|
-2.46
(2.07)
|
| Title | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 |
|---|---|
| Description | The mBPI-sf was a self-administered questionnaire used to assess the severity of pain and the impact of pain on daily functions during the 24-hour period prior to evaluation. It consisted of 5 questions. Questions (Q) 1-4 assessed the magnitude of pain (Q1 for worst pain, Q2 for least pain, Q3 for average pain, Q4 for pain right now) on an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine), with lower scores indicating less pain. Question 5 consisted of 7 sub-items (A to G; general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life) which measured the level of interference of pain on daily functions. Each sub-item was assessed on an 11-point NRS ranging from 0 (does not interfere) to 10 (completely interferes). Results are reported for worst and average pain score, each ranging from 0 (no pain) to 10 (pain as bad as you can imagine), with lower scores indicating less pain. |
| Time Frame | Baseline, Week 1, 2, 4, 6, 8, 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo infusion). Here 'number analyzed' signifies those participants who were evaluable for this measure at given time points. |
| Arm/Group Title | Tanezumab | Naproxen | Placebo |
|---|---|---|---|
| Arm/Group Description | Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12. | Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12. | Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12. |
| Measure Participants | 88 | 88 | 41 |
| Baseline: Worst Pain |
6.89
(1.69)
|
7.02
(1.74)
|
7.29
(1.65)
|
| Baseline: Average Pain |
5.99
(1.43)
|
6.18
(1.42)
|
6.54
(1.64)
|
| Change at Week 1: Worst Pain |
-2.54
(2.33)
|
-2.40
(2.02)
|
-1.88
(2.38)
|
| Change at Week 1: Average Pain |
-2.09
(2.07)
|
-2.02
(1.77)
|
-1.46
(1.95)
|
| Change at Week 2: Worst Pain |
-2.21
(2.53)
|
-2.67
(2.24)
|
-2.28
(2.25)
|
| Change at Week 2: Average Pain |
-1.97
(2.01)
|
-2.20
(1.82)
|
-2.22
(2.22)
|
| Change at Week 4: Worst Pain |
-3.54
(2.17)
|
-2.57
(2.29)
|
-2.47
(3.25)
|
| Change at Week 4: Average Pain |
-2.99
(1.91)
|
-2.37
(1.87)
|
-2.61
(2.56)
|
| Change at Week 6: Worst Pain |
-3.67
(2.45)
|
-2.87
(2.34)
|
-2.29
(3.30)
|
| Change at Week 6: Average Pain |
-3.29
(1.85)
|
-2.45
(1.98)
|
-2.65
(2.39)
|
| Change at Week 8: Worst Pain |
-3.85
(2.37)
|
-2.89
(2.56)
|
-2.90
(2.77)
|
| Change at Week 8: Average Pain |
-3.26
(1.89)
|
-2.44
(2.03)
|
-2.80
(2.30)
|
| Change at Week 12: Worst Pain |
-3.40
(2.37)
|
-2.93
(2.66)
|
-2.83
(3.17)
|
| Change at Week 12: Average Pain |
-3.00
(1.92)
|
-2.45
(2.36)
|
-2.88
(2.47)
|
| Title | Number of Participants With Average Low Back Pain Intensity (LBPI) Score of 2 or Less |
|---|---|
| Description | Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), with lower scores indicating less pain. Weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week. Participants were classified as responders if average LBPI score was 2 or less, and as non-responders if average LBPI score was greater than (>) 2. Participants with average LBPI score of 2 or less were reported. |
| Time Frame | Week 1, 2, 4, 6, 8, 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo infusion). Last observation carried forward (LOCF) method was used to impute missing values. |
| Arm/Group Title | Tanezumab | Naproxen | Placebo |
|---|---|---|---|
| Arm/Group Description | Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12. | Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12. | Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12. |
| Measure Participants | 88 | 88 | 41 |
| Week 1 |
18
20.5%
|
13
14.8%
|
2
4.9%
|
| Week 2 |
20
22.7%
|
19
21.6%
|
4
9.8%
|
| Week 4 |
27
30.7%
|
19
21.6%
|
6
14.6%
|
| Week 6 |
33
37.5%
|
21
23.9%
|
5
12.2%
|
| Week 8 |
32
36.4%
|
25
28.4%
|
8
19.5%
|
| Week 12 |
26
29.5%
|
21
23.9%
|
6
14.6%
|
| Title | Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6 |
|---|---|
| Description | Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), with lower scores indicating less pain. Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week. Number of participants with cumulative reduction (as percent) (greater than 0% ; >= 10, 20, 30, 40, 50, 60, 70, 80 and 90%; = 100 %) in Average LBPI score from Baseline at Week 6 were reported, participants (%) are reported more than once in categories specified. |
| Time Frame | Week 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo infusion). LOCF method was used to impute missing values. |
| Arm/Group Title | Tanezumab | Naproxen | Placebo |
|---|---|---|---|
| Arm/Group Description | Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12. | Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12. | Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12. |
| Measure Participants | 88 | 88 | 41 |
| Greater than 0% reduction |
79
89.8%
|
77
87.5%
|
34
82.9%
|
| Greater than or equal to (>=)10% reduction |
75
85.2%
|
72
81.8%
|
29
70.7%
|
| >=20% reduction |
68
77.3%
|
64
72.7%
|
21
51.2%
|
| >=30% reduction |
65
73.9%
|
50
56.8%
|
13
31.7%
|
| >=40% reduction |
58
65.9%
|
41
46.6%
|
12
29.3%
|
| >=50% reduction |
50
56.8%
|
30
34.1%
|
8
19.5%
|
| >=60% reduction |
40
45.5%
|
26
29.5%
|
7
17.1%
|
| >=70% reduction |
25
28.4%
|
16
18.2%
|
5
12.2%
|
| >=80% reduction |
16
18.2%
|
9
10.2%
|
3
7.3%
|
| >=90% reduction |
10
11.4%
|
5
5.7%
|
1
2.4%
|
| 100% reduction |
6
6.8%
|
3
3.4%
|
0
0%
|
| Title | Number of Participants With at Least 30% and 50% Sustained Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score |
|---|---|
| Description | Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week. Participants with >=30% or >=50% reduction from baseline in daily average LBPI score that was maintained for a minimum duration of 4 consecutive days were reported. |
| Time Frame | Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo infusion). Here '"overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure |
| Arm/Group Title | Tanezumab | Naproxen | Placebo |
|---|---|---|---|
| Arm/Group Description | Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12. | Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12. | Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12. |
| Measure Participants | 88 | 87 | 41 |
| >=30% reduction |
71
80.7%
|
60
68.2%
|
26
63.4%
|
| >=50% reduction |
62
70.5%
|
50
56.8%
|
20
48.8%
|
| Title | Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score |
|---|---|
| Description | Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), with lower scores indicating less pain. Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week. Number of participants with >=30% and >=50% reduction from Baseline in daily average LBPI score were reported. |
| Time Frame | Weeks 1, 2, 4, 6, 8, 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo infusion). LOCF method was used to impute missing values. |
| Arm/Group Title | Tanezumab | Naproxen | Placebo |
|---|---|---|---|
| Arm/Group Description | Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12. | Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12. | Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12. |
| Measure Participants | 88 | 88 | 41 |
| Week 1: >=30% reduction |
46
52.3%
|
45
51.1%
|
8
19.5%
|
| Week 1: >=50% reduction |
28
31.8%
|
26
29.5%
|
5
12.2%
|
| Week 2: >=30% reduction |
42
47.7%
|
48
54.5%
|
14
34.1%
|
| Week 2: >=50% reduction |
28
31.8%
|
31
35.2%
|
7
17.1%
|
| Week 4: >=30% reduction |
62
70.5%
|
50
56.8%
|
16
39%
|
| Week 4: >=50% reduction |
43
48.9%
|
28
31.8%
|
10
24.4%
|
| Week 6: >=30% reduction |
65
73.9%
|
50
56.8%
|
13
31.7%
|
| Week 6: >=50% reduction |
50
56.8%
|
30
34.1%
|
8
19.5%
|
| Week 8: >=30% reduction |
66
75%
|
51
58%
|
18
43.9%
|
| Week 8: >=50% reduction |
49
55.7%
|
33
37.5%
|
9
22%
|
| Week 12: >=30% reduction |
59
67%
|
45
51.1%
|
20
48.8%
|
| Week 12: >=50% reduction |
43
48.9%
|
30
34.1%
|
12
29.3%
|
| Title | Time to Achieve at Least 30% and 50% Sustained Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score |
|---|---|
| Description | Time to achieve >=30% or >=50% sustained reduction from baseline (i.e. reduction from baseline in daily average LBPI score that was maintained for a total of 4 consecutive days) was summarized using the Kaplan-Meier estimates of the median time to 30% and 50% response. Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), with lower scores indicating less pain. Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week. |
| Time Frame | Randomization to Last Study Visit (up to 16 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo infusion). Here "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. |
| Arm/Group Title | Tanezumab | Naproxen | Placebo |
|---|---|---|---|
| Arm/Group Description | Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12. | Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12. | Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12. |
| Measure Participants | 88 | 87 | 41 |
| Time to >=30% reduction |
8
|
7
|
17
|
| Time to >=50% reduction |
18
|
41
|
65
|
| Title | Total Duration of at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score |
|---|---|
| Description | Total duration of response was defined as the total number of days with >=30% or >=50% reduction from baseline in the daily average LBPI score. Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), with lower scores indicating less pain. Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week. |
| Time Frame | Week 1 up to Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo infusion). |
| Arm/Group Title | Tanezumab | Naproxen | Placebo |
|---|---|---|---|
| Arm/Group Description | Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12. | Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12. | Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12. |
| Measure Participants | 88 | 88 | 41 |
| Total duration for >=30% reduction |
43.91
(3.54)
|
38.81
(3.59)
|
33.13
(4.82)
|
| Total duration for >=50% reduction |
33.21
(3.30)
|
27.58
(3.34)
|
22.08
(4.49)
|
| Title | Change From Baseline in Roland-Morris Disability Questionnaire Total Score at Week 1, 2, 4, 6, 8, and 12 |
|---|---|
| Description | Roland-Morris Disability Questionnaire: low back pain-specific, participant administered questionnaire that assessed how well participants with low back pain were able to function with regard to daily activities. The questionnaire consisted of 24 statements and the participants were instructed to put a mark next to each appropriate statement if it described their pain on the day of assessment. The number of statements marked were added up by the clinician. Total RMDQ score was calculated as the sum of number of statements checked. Total possible score ranged from 0 to 24, with higher scores indicated greater disability. |
| Time Frame | Baseline, Week 1, 2, 4, 6, 8, 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population. Here "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure and 'number analyzed' signifies those participants who were evaluable for this measure at given time points. |
| Arm/Group Title | Tanezumab | Naproxen | Placebo |
|---|---|---|---|
| Arm/Group Description | Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12. | Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12. | Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12. |
| Measure Participants | 87 | 88 | 41 |
| Baseline |
12.33
(4.63)
|
12.36
(4.80)
|
13.68
(5.17)
|
| Change at Week 1 |
-5.21
(5.24)
|
-3.69
(5.11)
|
-3.76
(5.25)
|
| Change at Week 2 |
-5.17
(5.59)
|
-4.04
(5.37)
|
-4.08
(6.25)
|
| Change at Week 4 |
-7.24
(5.33)
|
-4.00
(4.99)
|
-4.31
(5.81)
|
| Change at Week 6 |
-7.88
(5.39)
|
-4.69
(5.34)
|
-4.55
(6.55)
|
| Change at Week 8 |
-7.93
(4.97)
|
-5.17
(5.32)
|
-5.60
(6.22)
|
| Change at Week 12 |
-7.12
(6.00)
|
-5.10
(5.50)
|
-4.67
(6.84)
|
| Title | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 |
|---|---|
| Description | The mBPI-sf was a self-administered questionnaire used to assess the severity of pain and the impact of pain on daily functions during the 24-hour period prior to evaluation. It consisted of 5 questions. Questions 1 to 4 assessed the magnitude of pain (worst, least, average, right now) on an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). Question 5 consisted of 7 sub-items (general activity [GA], mood, walking ability [WA], normal work [NW], relations with other people, sleep, enjoyment of life) which measured the level of interference of pain on daily functions. Each sub-item was assessed on an 11-point NRS ranging from 0 (did not interfere) to 10 (completely interfere). The response from 7 sub-items of question 5 were averaged to obtain pain interference composite score (CS), range: 0 to 10 (higher score=more interference). |
| Time Frame | Baseline, Week 1, 2, 4, 6, 8, 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo infusion). Here 'number analyzed' signifies those participants who were evaluable for this measure at given time points. |
| Arm/Group Title | Tanezumab | Naproxen | Placebo |
|---|---|---|---|
| Arm/Group Description | Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12. | Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12. | Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12. |
| Measure Participants | 88 | 88 | 41 |
| Baseline: CS |
4.81
(2.19)
|
5.43
(2.14)
|
5.29
(2.25)
|
| Baseline: GA |
5.55
(2.26)
|
5.83
(2.25)
|
5.49
(2.72)
|
| Baseline: WA |
4.46
(2.80)
|
5.25
(2.66)
|
5.15
(2.81)
|
| Baseline: NW |
5.15
(2.48)
|
5.89
(2.38)
|
5.80
(2.39)
|
| Baseline: Sleep |
5.69
(2.70)
|
5.75
(2.69)
|
6.20
(2.44)
|
| Change at Week 1: CS |
-2.52
(2.13)
|
-2.51
(2.46)
|
-2.07
(2.17)
|
| Change at Week 1: GA |
-3.10
(2.63)
|
-2.51
(2.82)
|
-1.88
(2.47)
|
| Change at Week 1: WA |
-2.35
(2.64)
|
-2.04
(2.96)
|
-2.17
(2.94)
|
| Change at Week 1: NW |
-2.75
(2.41)
|
-2.40
(2.84)
|
-2.22
(2.75)
|
| Change at Week 1: Sleep |
-2.73
(2.52)
|
-2.87
(3.02)
|
-2.27
(2.53)
|
| Change at Week 2: CS |
-2.17
(2.13)
|
-2.82
(2.41)
|
-2.70
(2.71)
|
| Change at Week 2: GA |
-2.61
(2.58)
|
-2.94
(2.84)
|
-2.58
(3.54)
|
| Change at Week 2: WA |
-1.87
(2.94)
|
-2.48
(2.79)
|
-2.64
(3.16)
|
| Change at Week 2: NW |
-2.45
(2.55)
|
-3.02
(2.61)
|
-2.92
(3.08)
|
| Change at Week 2: Sleep |
-2.41
(2.49)
|
-2.88
(2.70)
|
-3.19
(2.88)
|
| Change at Week 4: CS |
-3.13
(2.01)
|
-2.52
(2.35)
|
-2.72
(2.80)
|
| Change at Week 4: GA |
-3.62
(2.29)
|
-2.58
(2.72)
|
-2.36
(3.87)
|
| Change at Week 4: WA |
-2.87
(2.50)
|
-2.09
(2.72)
|
-2.81
(3.04)
|
| Change at Week 4: NW |
-3.55
(2.36)
|
-2.63
(2.65)
|
-2.81
(3.25)
|
| Change at Week 4: Sleep |
-3.54
(2.51)
|
-2.63
(3.20)
|
-3.08
(2.90)
|
| Change at Week 6: CS |
-3.25
(1.85)
|
-2.84
(2.29)
|
-2.76
(2.61)
|
| Change at Week 6: GA |
-3.65
(2.12)
|
-2.97
(2.66)
|
-2.68
(3.07)
|
| Change at Week 6: WA |
-3.11
(2.55)
|
-2.48
(2.86)
|
-2.39
(2.84)
|
| Change at Week 6: NW |
-3.55
(2.04)
|
-2.95
(2.74)
|
-2.87
(3.12)
|
| Change at Week 6: Sleep |
-3.92
(2.54)
|
-2.99
(2.95)
|
-3.03
(2.58)
|
| Change at Week 8: CS |
-3.19
(1.84)
|
-3.01
(2.31)
|
-3.04
(2.73)
|
| Change at Week 8: GA |
-3.72
(2.22)
|
-3.14
(2.78)
|
-2.93
(3.27)
|
| Change at Week 8: WA |
-3.05
(2.56)
|
-2.62
(3.04)
|
-2.87
(3.07)
|
| Change at Week 8: NW |
-3.62
(2.08)
|
-3.24
(2.59)
|
-3.33
(3.13)
|
| Change at Week 8: Sleep |
-3.47
(2.45)
|
-3.51
(2.93)
|
-3.33
(2.80)
|
| Change at Week 12: CS |
-3.08
(2.01)
|
-2.84
(2.34)
|
-2.74
(3.15)
|
| Change at Week 12: GA |
-3.45
(2.42)
|
-3.01
(2.93)
|
-2.92
(3.79)
|
| Change at Week 12: WA |
-2.78
(2.71)
|
-2.54
(2.87)
|
-2.04
(3.48)
|
| Change at Week 12: NW |
-3.36
(2.43)
|
-2.97
(2.63)
|
-3.17
(3.29)
|
| Change at Week 12: Sleep |
-3.58
(2.44)
|
-3.33
(2.87)
|
-3.08
(2.80)
|
| Title | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 |
|---|---|
| Description | Patient's global assessment of low back pain scale assessed participants overall impression of disease activity. Participants answered: "Considering all the ways your low back pain affects you, how are you doing today?" Participants responded using 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). Participants who reported a change of -4, -3, -2, -1, 0, 1, 2, 3, 4 from Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) score at specified weeks were presented. |
| Time Frame | Week 1, 2, 4, 6, 8, 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population. Here "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure and 'number analyzed' signifies those participants who were evaluable for this measure at given time points. |
| Arm/Group Title | Tanezumab | Naproxen | Placebo |
|---|---|---|---|
| Arm/Group Description | Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12. | Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12. | Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12. |
| Measure Participants | 77 | 84 | 41 |
| Week 1: Change= -4 |
1
1.1%
|
0
0%
|
0
0%
|
| Week 1: Change= -3 |
1
1.1%
|
2
2.3%
|
1
2.4%
|
| Week 1: Change= -2 |
24
27.3%
|
18
20.5%
|
6
14.6%
|
| Week 1: Change= -1 |
23
26.1%
|
33
37.5%
|
14
34.1%
|
| Week 1: Change= 0 |
25
28.4%
|
26
29.5%
|
17
41.5%
|
| Week 1: Change= 1 |
2
2.3%
|
4
4.5%
|
3
7.3%
|
| Week 1: Change= 2 |
1
1.1%
|
1
1.1%
|
0
0%
|
| Week 1: Change= 3 |
0
0%
|
0
0%
|
0
0%
|
| Week 1: Change= 4 |
0
0%
|
0
0%
|
0
0%
|
| Week 2: Change= -4 |
1
1.1%
|
1
1.1%
|
0
0%
|
| Week 2: Change= -3 |
2
2.3%
|
4
4.5%
|
4
9.8%
|
| Week 2: Change= -2 |
16
18.2%
|
17
19.3%
|
5
12.2%
|
| Week 2: Change= -1 |
26
29.5%
|
30
34.1%
|
17
41.5%
|
| Week 2: Change= 0 |
24
27.3%
|
23
26.1%
|
8
19.5%
|
| Week 2: Change= 1 |
6
6.8%
|
6
6.8%
|
2
4.9%
|
| Week 2: Change= 2 |
1
1.1%
|
1
1.1%
|
0
0%
|
| Week 2: Change= 3 |
0
0%
|
0
0%
|
0
0%
|
| Week 2: Change= 4 |
0
0%
|
0
0%
|
0
0%
|
| Week 4: Change= -4 |
1
1.1%
|
1
1.1%
|
0
0%
|
| Week 4: Change= -3 |
0
0%
|
2
2.3%
|
5
12.2%
|
| Week 4: Change= -2 |
22
25%
|
18
20.5%
|
6
14.6%
|
| Week 4: Change= -1 |
30
34.1%
|
32
36.4%
|
15
36.6%
|
| Week 4: Change= 0 |
14
15.9%
|
20
22.7%
|
7
17.1%
|
| Week 4: Change= 1 |
0
0%
|
4
4.5%
|
3
7.3%
|
| Week 4: Change= 2 |
0
0%
|
2
2.3%
|
0
0%
|
| Week 4: Change= 3 |
0
0%
|
0
0%
|
0
0%
|
| Week 4: Change= 4 |
0
0%
|
0
0%
|
0
0%
|
| Week 6: Change= -4 |
2
2.3%
|
0
0%
|
0
0%
|
| Week 6: Change= -3 |
2
2.3%
|
7
8%
|
3
7.3%
|
| Week 6: Change= -2 |
25
28.4%
|
22
25%
|
5
12.2%
|
| Week 6: Change= -1 |
20
22.7%
|
18
20.5%
|
12
29.3%
|
| Week 6: Change= 0 |
15
17%
|
20
22.7%
|
10
24.4%
|
| Week 6: Change= 1 |
1
1.1%
|
7
8%
|
1
2.4%
|
| Week 6: Change= 2 |
0
0%
|
1
1.1%
|
0
0%
|
| Week 6: Change= 3 |
0
0%
|
0
0%
|
0
0%
|
| Week 6: Change= 4 |
0
0%
|
0
0%
|
0
0%
|
| Week 8: Change= -4 |
0
0%
|
0
0%
|
0
0%
|
| Week 8: Change= -3 |
2
2.3%
|
5
5.7%
|
2
4.9%
|
| Week 8: Change= -2 |
23
26.1%
|
17
19.3%
|
6
14.6%
|
| Week 8: Change= -1 |
23
26.1%
|
25
28.4%
|
14
34.1%
|
| Week 8: Change= 0 |
11
12.5%
|
19
21.6%
|
4
9.8%
|
| Week 8: Change= 1 |
1
1.1%
|
4
4.5%
|
4
9.8%
|
| Week 8: Change= 2 |
0
0%
|
1
1.1%
|
0
0%
|
| Week 8: Change= 3 |
0
0%
|
0
0%
|
0
0%
|
| Week 8: Change= 4 |
0
0%
|
0
0%
|
0
0%
|
| Week 12: Change= -4 |
1
1.1%
|
0
0%
|
0
0%
|
| Week 12: Change= -3 |
1
1.1%
|
6
6.8%
|
4
9.8%
|
| Week 12: Change= -2 |
14
15.9%
|
15
17%
|
2
4.9%
|
| Week 12: Change= -1 |
22
25%
|
21
23.9%
|
9
22%
|
| Week 12: Change= 0 |
20
22.7%
|
14
15.9%
|
7
17.1%
|
| Week 12: Change= 1 |
1
1.1%
|
11
12.5%
|
1
2.4%
|
| Week 12: Change= 2 |
0
0%
|
0
0%
|
1
2.4%
|
| Week 12: Change= 3 |
0
0%
|
0
0%
|
0
0%
|
| Week 12: Change= 4 |
0
0%
|
0
0%
|
0
0%
|
| Title | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication |
|---|---|
| Description | Participants answered: "In all ways, how would you rate your overall response to the study medication today?" Participants responded using a 4-point Likert scale where 1 = poor, 2 = fair, 3 = good and 4 = excellent. Higher score indicated better overall response to the treatment. |
| Time Frame | Week 1, 2, 4, 6, 8, 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population. Here "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure and 'number analyzed' signifies those participants who were evaluable for this measure at given time points. |
| Arm/Group Title | Tanezumab | Naproxen | Placebo |
|---|---|---|---|
| Arm/Group Description | Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12. | Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12. | Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12. |
| Measure Participants | 78 | 84 | 40 |
| Week 1: Poor |
7
8%
|
13
14.8%
|
12
29.3%
|
| Week 1: Fair |
16
18.2%
|
22
25%
|
11
26.8%
|
| Week 1: Good |
29
33%
|
32
36.4%
|
14
34.1%
|
| Week 1: Excellent |
26
29.5%
|
17
19.3%
|
3
7.3%
|
| Week 2: Poor |
10
11.4%
|
16
18.2%
|
6
14.6%
|
| Week 2: Fair |
17
19.3%
|
14
15.9%
|
11
26.8%
|
| Week 2: Good |
31
35.2%
|
34
38.6%
|
15
36.6%
|
| Week 2: Excellent |
19
21.6%
|
18
20.5%
|
4
9.8%
|
| Week 4: Poor |
4
4.5%
|
15
17%
|
8
19.5%
|
| Week 4: Fair |
5
5.7%
|
16
18.2%
|
10
24.4%
|
| Week 4: Good |
30
34.1%
|
27
30.7%
|
13
31.7%
|
| Week 4: Excellent |
29
33%
|
21
23.9%
|
5
12.2%
|
| Week 6: Poor |
1
1.1%
|
11
12.5%
|
8
19.5%
|
| Week 6: Fair |
10
11.4%
|
23
26.1%
|
5
12.2%
|
| Week 6: Good |
22
25%
|
23
26.1%
|
14
34.1%
|
| Week 6: Excellent |
32
36.4%
|
18
20.5%
|
4
9.8%
|
| Week 8: Poor |
1
1.1%
|
9
10.2%
|
6
14.6%
|
| Week 8: Fair |
8
9.1%
|
24
27.3%
|
7
17.1%
|
| Week 8: Good |
20
22.7%
|
19
21.6%
|
13
31.7%
|
| Week 8: Excellent |
32
36.4%
|
19
21.6%
|
4
9.8%
|
| Week 12: Poor |
6
6.8%
|
15
17%
|
6
14.6%
|
| Week 12: Fair |
9
10.2%
|
17
19.3%
|
6
14.6%
|
| Week 12: Good |
21
23.9%
|
18
20.5%
|
5
12.2%
|
| Week 12: Excellent |
23
26.1%
|
17
19.3%
|
7
17.1%
|
| Title | Number of Participants Who Discontinued the Study Due to Lack of Efficacy |
|---|---|
| Description | |
| Time Frame | Baseline up to Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo infusion). |
| Arm/Group Title | Tanezumab | Naproxen | Placebo |
|---|---|---|---|
| Arm/Group Description | Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12. | Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12. | Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12. |
| Measure Participants | 88 | 88 | 41 |
| Count of Participants [Participants] |
7
8%
|
14
15.9%
|
8
19.5%
|
| Title | Time to Discontinuation Due to Lack of Efficacy |
|---|---|
| Description | Median time to discontinuation due to lack of efficacy was estimated using Kaplan-Meier method. Median was not estimable if the percentage of participants who discontinued due to lack of efficacy was below 50%. |
| Time Frame | Baseline up to Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo infusion). |
| Arm/Group Title | Tanezumab | Naproxen | Placebo |
|---|---|---|---|
| Arm/Group Description | Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12. | Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12. | Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12. |
| Measure Participants | 88 | 88 | 41 |
| Median (Full Range) [days] |
NA
|
NA
|
NA
|
| Title | Number of Participants With Chronic Low Back Pain (CLBP) Response |
|---|---|
| Description | Participants were considered as CLBP responders if they had achieved a reduction of >=30% in daily average LBPI score from baseline, an increase of >=30% in patient's global assessment of low back pain (disease activity) from baseline, and no worsening (increase) in RMDQ total score from baseline at specified week. Daily average low back pain assessed on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain). Patient's global assessment of low back pain assessed using 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). RMDQ: low back pain-specific, participant administered questionnaire consisted of 24 statements and participants were instructed to put a mark next to each appropriate statement if it described their pain on the day of assessment. Total RMDQ score was calculated as sum of number of statements checked. Total possible score ranged from 0 to 24, with higher scores indicated greater disability. |
| Time Frame | Weeks 1, 2, 4, 6, 8, 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo infusion). LOCF method was used to impute missing values. Here "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure |
| Arm/Group Title | Tanezumab | Naproxen | Placebo |
|---|---|---|---|
| Arm/Group Description | Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12. | Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12. | Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12. |
| Measure Participants | 87 | 88 | 41 |
| Week 1 |
33
37.5%
|
30
34.1%
|
6
14.6%
|
| Week 2 |
32
36.4%
|
34
38.6%
|
9
22%
|
| Week 4 |
51
58%
|
31
35.2%
|
11
26.8%
|
| Week 6 |
50
56.8%
|
39
44.3%
|
9
22%
|
| Week 8 |
48
54.5%
|
36
40.9%
|
14
34.1%
|
| Week 12 |
38
43.2%
|
30
34.1%
|
12
29.3%
|
| Title | Number of Participants Who Used Rescue Medications |
|---|---|
| Description | In case of inadequate pain relief for CLBP or for non-CLBP related pain, acetaminophen up to 2000 mg per day up to 3 days per week could be taken as rescue medication. Number of participants with any use of rescue medication during the particular study week were summarized. |
| Time Frame | Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo infusion). Here 'number analyzed' signifies those participants who were evaluable for this measure at given time points. |
| Arm/Group Title | Tanezumab | Naproxen | Placebo |
|---|---|---|---|
| Arm/Group Description | Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12. | Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12. | Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12. |
| Measure Participants | 88 | 88 | 41 |
| Week 1 |
61
69.3%
|
50
56.8%
|
29
70.7%
|
| Week 2 |
65
73.9%
|
49
55.7%
|
27
65.9%
|
| Week 3 |
54
61.4%
|
42
47.7%
|
24
58.5%
|
| Week 4 |
40
45.5%
|
49
55.7%
|
28
68.3%
|
| Week 5 |
37
42%
|
46
52.3%
|
21
51.2%
|
| Week 6 |
36
40.9%
|
42
47.7%
|
20
48.8%
|
| Week 7 |
34
38.6%
|
38
43.2%
|
17
41.5%
|
| Week 8 |
31
35.2%
|
39
44.3%
|
19
46.3%
|
| Week 9 |
33
37.5%
|
38
43.2%
|
12
29.3%
|
| Week 10 |
30
34.1%
|
41
46.6%
|
14
34.1%
|
| Week 11 |
32
36.4%
|
31
35.2%
|
13
31.7%
|
| Week 12 |
30
34.1%
|
33
37.5%
|
16
39%
|
| Title | Duration of Rescue Medication Use |
|---|---|
| Description | In case of inadequate pain relief for CLBP or for non-CLBP related pain, acetaminophen up to 2000 mg per day up to 3 days per week could be taken as rescue medication. The number of days of rescue medication use during the particular week were summarized. |
| Time Frame | Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo infusion). Here 'number analyzed' signifies those participants who were evaluable for this measure at given time points. |
| Arm/Group Title | Tanezumab | Naproxen | Placebo |
|---|---|---|---|
| Arm/Group Description | Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12. | Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12. | Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12. |
| Measure Participants | 88 | 88 | 41 |
| Week 1 |
2
|
1
|
1
|
| Week 2 |
2
|
1
|
1.5
|
| Week 3 |
2
|
0.5
|
2
|
| Week 4 |
1
|
2
|
2
|
| Week 5 |
0
|
1
|
1
|
| Week 6 |
0.5
|
1
|
1
|
| Week 7 |
0
|
1
|
1
|
| Week 8 |
0
|
1
|
1
|
| Week 9 |
0.5
|
1
|
0
|
| Week 10 |
0
|
1
|
0
|
| Week 11 |
0.5
|
0
|
0
|
| Week 12 |
0
|
0
|
1
|
| Title | Amount of Rescue Medication Taken |
|---|---|
| Description | In case of inadequate pain relief for CLBP or for non-CLBP related pain, acetaminophen up to 2000 mg per day up to 3 days per week could be taken as rescue medication. The total dosage of acetaminophen (in mg) in each particular week was summarized. |
| Time Frame | Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo infusion). Here 'number analyzed' signifies those participants who were evaluable for this measure at given time points. |
| Arm/Group Title | Tanezumab | Naproxen | Placebo |
|---|---|---|---|
| Arm/Group Description | Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12. | Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12. | Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12. |
| Measure Participants | 88 | 88 | 41 |
| Week 1 |
2545.5
(2798.4)
|
2039.8
(2467.3)
|
2451.2
(2816.9)
|
| Week 2 |
3221.6
(3528.1)
|
2327.6
(3083.0)
|
2225.0
(2616.4)
|
| Week 3 |
2703.7
(3368.8)
|
2208.3
(3112.6)
|
2565.8
(2719.2)
|
| Week 4 |
2220.8
(3108.2)
|
2475.0
(2937.0)
|
2434.2
(2904.3)
|
| Week 5 |
2073.3
(3100.5)
|
2318.8
(2936.3)
|
2444.4
(3285.9)
|
| Week 6 |
2062.5
(2919.0)
|
2227.3
(3193.9)
|
2573.5
(3348.7)
|
| Week 7 |
1854.2
(3126.9)
|
1873.3
(2763.3)
|
2393.9
(3149.3)
|
| Week 8 |
2134.3
(3273.6)
|
2212.3
(3255.2)
|
1924.2
(2478.4)
|
| Week 9 |
1772.7
(2627.1)
|
2319.4
(3483.7)
|
1406.3
(2554.1)
|
| Week 10 |
1851.6
(2655.8)
|
2513.9
(3477.3)
|
1534.5
(2591.0)
|
| Week 11 |
1992.2
(2717.5)
|
2166.7
(3632.8)
|
1375.0
(2311.9)
|
| Week 12 |
1828.1
(2790.6)
|
2253.5
(3402.6)
|
1722.2
(2805.7)
|
| Title | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) |
|---|---|
| Description | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose (up to Week 16) that were absent before treatment or that worsened relative to pretreatment state. |
| Time Frame | Baseline up to 28 days after last dose of study treatment (up to Week 16) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo infusion). |
| Arm/Group Title | Tanezumab | Naproxen | Placebo |
|---|---|---|---|
| Arm/Group Description | Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12. | Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12. | Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12. |
| Measure Participants | 88 | 88 | 41 |
| AEs |
50
56.8%
|
54
61.4%
|
27
65.9%
|
| SAEs |
0
0%
|
2
2.3%
|
0
0%
|
| Title | Number of Participants With Anti-Drug Antibody (ADA) |
|---|---|
| Description | Human serum anti-drug antibody (ADA) samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA). |
| Time Frame | Baseline up to Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population included all randomized participants who received the Day 1 intravenous infusion of tanezumab. Data for this outcome measure was not planned to be collected and analyzed for Naproxen and Placebo arms. |
| Arm/Group Title | Tanezumab |
|---|---|
| Arm/Group Description | Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12. |
| Measure Participants | 88 |
| Count of Participants [Participants] |
0
0%
|
Adverse Events
| Time Frame | ||||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. | |||||
| Arm/Group Title | Tanezumab | Naproxen | Placebo | |||
| Arm/Group Description | Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12. | Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12. | Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12. | |||
All Cause Mortality |
||||||
| Tanezumab | Naproxen | Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| Tanezumab | Naproxen | Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/88 (0%) | 2/88 (2.3%) | 0/41 (0%) | |||
| Cardiac disorders | ||||||
| Atrial fibrillation | 0/88 (0%) | 1/88 (1.1%) | 0/41 (0%) | |||
| Nervous system disorders | ||||||
| Syncope vasovagal | 0/88 (0%) | 1/88 (1.1%) | 0/41 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Tanezumab | Naproxen | Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 44/88 (50%) | 45/88 (51.1%) | 27/41 (65.9%) | |||
| Ear and labyrinth disorders | ||||||
| Vertigo | 2/88 (2.3%) | 1/88 (1.1%) | 0/41 (0%) | |||
| Eye disorders | ||||||
| Conjunctivitis | 2/88 (2.3%) | 0/88 (0%) | 0/41 (0%) | |||
| Diplopia | 0/88 (0%) | 0/88 (0%) | 1/41 (2.4%) | |||
| Dry eye | 0/88 (0%) | 0/88 (0%) | 1/41 (2.4%) | |||
| Vision blurred | 2/88 (2.3%) | 0/88 (0%) | 0/41 (0%) | |||
| Gastrointestinal disorders | ||||||
| Abdominal pain upper | 0/88 (0%) | 4/88 (4.5%) | 1/41 (2.4%) | |||
| Diarrhoea | 2/88 (2.3%) | 1/88 (1.1%) | 3/41 (7.3%) | |||
| Dyspepsia | 1/88 (1.1%) | 0/88 (0%) | 1/41 (2.4%) | |||
| Gastrooesophageal reflux disease | 1/88 (1.1%) | 2/88 (2.3%) | 0/41 (0%) | |||
| Nausea | 2/88 (2.3%) | 1/88 (1.1%) | 1/41 (2.4%) | |||
| Stomach discomfort | 0/88 (0%) | 1/88 (1.1%) | 1/41 (2.4%) | |||
| General disorders | ||||||
| Chest discomfort | 2/88 (2.3%) | 0/88 (0%) | 0/41 (0%) | |||
| Chest pain | 1/88 (1.1%) | 1/88 (1.1%) | 1/41 (2.4%) | |||
| Fatigue | 2/88 (2.3%) | 1/88 (1.1%) | 1/41 (2.4%) | |||
| Influenza like illness | 1/88 (1.1%) | 0/88 (0%) | 1/41 (2.4%) | |||
| Immune system disorders | ||||||
| Seasonal allergy | 0/88 (0%) | 2/88 (2.3%) | 1/41 (2.4%) | |||
| Infections and infestations | ||||||
| Bronchitis | 2/88 (2.3%) | 0/88 (0%) | 2/41 (4.9%) | |||
| Ear infection | 3/88 (3.4%) | 0/88 (0%) | 0/41 (0%) | |||
| Gastroenteritis | 0/88 (0%) | 1/88 (1.1%) | 1/41 (2.4%) | |||
| Influenza | 3/88 (3.4%) | 5/88 (5.7%) | 1/41 (2.4%) | |||
| Nasopharyngitis | 2/88 (2.3%) | 6/88 (6.8%) | 1/41 (2.4%) | |||
| Sinusitis | 1/88 (1.1%) | 5/88 (5.7%) | 0/41 (0%) | |||
| Upper respiratory tract infection | 4/88 (4.5%) | 4/88 (4.5%) | 2/41 (4.9%) | |||
| Urinary tract infection | 3/88 (3.4%) | 4/88 (4.5%) | 0/41 (0%) | |||
| Injury, poisoning and procedural complications | ||||||
| Contusion | 1/88 (1.1%) | 6/88 (6.8%) | 0/41 (0%) | |||
| Fall | 0/88 (0%) | 0/88 (0%) | 2/41 (4.9%) | |||
| Joint injury | 0/88 (0%) | 0/88 (0%) | 1/41 (2.4%) | |||
| Joint sprain | 3/88 (3.4%) | 0/88 (0%) | 0/41 (0%) | |||
| Limb injury | 0/88 (0%) | 0/88 (0%) | 1/41 (2.4%) | |||
| Skin laceration | 2/88 (2.3%) | 0/88 (0%) | 0/41 (0%) | |||
| Investigations | ||||||
| Blood creatine phosphokinase increased | 1/88 (1.1%) | 0/88 (0%) | 1/41 (2.4%) | |||
| Metabolism and nutrition disorders | ||||||
| Hypokalaemia | 0/88 (0%) | 0/88 (0%) | 1/41 (2.4%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Arthralgia | 13/88 (14.8%) | 6/88 (6.8%) | 0/41 (0%) | |||
| Back pain | 3/88 (3.4%) | 5/88 (5.7%) | 1/41 (2.4%) | |||
| Joint swelling | 3/88 (3.4%) | 0/88 (0%) | 0/41 (0%) | |||
| Muscle spasms | 1/88 (1.1%) | 0/88 (0%) | 2/41 (4.9%) | |||
| Muscle twitching | 0/88 (0%) | 0/88 (0%) | 1/41 (2.4%) | |||
| Myalgia | 7/88 (8%) | 0/88 (0%) | 2/41 (4.9%) | |||
| Pain in extremity | 4/88 (4.5%) | 2/88 (2.3%) | 2/41 (4.9%) | |||
| Nervous system disorders | ||||||
| Dysaesthesia | 2/88 (2.3%) | 0/88 (0%) | 0/41 (0%) | |||
| Headache | 10/88 (11.4%) | 5/88 (5.7%) | 8/41 (19.5%) | |||
| Hyperaesthesia | 6/88 (6.8%) | 0/88 (0%) | 0/41 (0%) | |||
| Hypoaesthesia | 0/88 (0%) | 0/88 (0%) | 1/41 (2.4%) | |||
| Pallanaesthesia | 0/88 (0%) | 2/88 (2.3%) | 0/41 (0%) | |||
| Paraesthesia | 4/88 (4.5%) | 1/88 (1.1%) | 0/41 (0%) | |||
| Restless legs syndrome | 0/88 (0%) | 0/88 (0%) | 1/41 (2.4%) | |||
| Sinus headache | 2/88 (2.3%) | 1/88 (1.1%) | 0/41 (0%) | |||
| Syncope | 0/88 (0%) | 0/88 (0%) | 1/41 (2.4%) | |||
| Transient ischaemic attack | 0/88 (0%) | 0/88 (0%) | 1/41 (2.4%) | |||
| Psychiatric disorders | ||||||
| Abnormal dreams | 0/88 (0%) | 0/88 (0%) | 1/41 (2.4%) | |||
| Anxiety | 2/88 (2.3%) | 1/88 (1.1%) | 0/41 (0%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Cough | 2/88 (2.3%) | 1/88 (1.1%) | 0/41 (0%) | |||
| Pharyngolaryngeal pain | 2/88 (2.3%) | 1/88 (1.1%) | 0/41 (0%) | |||
| Pulmonary congestion | 0/88 (0%) | 0/88 (0%) | 1/41 (2.4%) | |||
| Rhinitis allergic | 0/88 (0%) | 2/88 (2.3%) | 0/41 (0%) | |||
| Sinus congestion | 1/88 (1.1%) | 1/88 (1.1%) | 1/41 (2.4%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Acne | 0/88 (0%) | 0/88 (0%) | 1/41 (2.4%) | |||
| Rash | 0/88 (0%) | 0/88 (0%) | 1/41 (2.4%) | |||
| Vascular disorders | ||||||
| Flushing | 0/88 (0%) | 0/88 (0%) | 1/41 (2.4%) | |||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
| Name/Title | Pfizer ClinicalTrials.gov Call Center |
|---|---|
| Organization | Pfizer, Inc. |
| Phone | 1-800-718-1021 |
| ClinicalTrials.gov_Inquiries@pfizer.com |
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT00584870
Other Study ID Numbers:
- A4091004
- CLBP POC
First Posted:
Jan 2, 2008
Last Update Posted:
Jul 12, 2021
Last Verified:
Jun 1, 2021