Low Back Pain
Conditions
Keywords
randomized controlled trial, monoclonal antibody, nerve growth factor, naproxen
Brief summary
The purpose of this study is to evaluate the efficacy and safety of multiple doses of tanezumab administered every 8 weeks in treating chronic low back pain. Tanezumab is a monoclonal antibody directed against human nerve growth factor.
Interventions
BIOLOGICALTanezumab 20 mg IV
2 IV administrations of tanezumab 20 mg at an 8 week interval
Oral placebo for naproxen twice a day for 16 weeks
BIOLOGICALTanezumab 10 mg IV
2 IV administrations of tanezumab 10 mg at an 8 week interval
BIOLOGICALTanezumab 5 mg IV
2 IV administrations of tanezumab 5 mg at an 8 week interval
BIOLOGICALPlacebo for tanezumab
2 IV administrations of placebo for tanezumab at an 8 week interval
DRUGNaproxen
Oral naproxen 500 mg twice a day for 16 weeks
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Present with duration of low back pain of ≥3 months requiring regular use of analgesic medication (\>4 days per week for the past month). Analgesic medication may consist of NSAIDs, selective COX-2 inhibitors, immediate release opioids, or combinations, with certain protocol-defined limitations. * Primary location of low back pain must be between the 12th thoracic vertebra and the lower gluteal folds, with or without radiation into the posterior thigh * Must meet criteria for pain severity and global assessment of low back pain at Screening and Baseline visits * Female patients of child-bearing potential (and male patients with female partners who are of child-bearing potential) must use 2 methods of contraception throughout the study * Patients must be willing to discontinue all pain medications for chronic low back pain except rescue medication and not use prohibited pain medications throughout the duration of the study
Exclusion criteria
* History of lumbosacral radiculopathy within the past 2 years. * Back pain due to visceral disorder (eg, endometriosis). * Back pain due to major trauma or osteoporotic compression fracture in the past 6 months. * History of rheumatoid arthritis, seronegative spondyloarthropathy, Paget's disease of spine, pelvis or femur; fibromyalgia; tumors or infections of the spinal cord. * Surgical intervention during the past 6 months for the treatment of low back pain or plans for surgical intervention during the course of the study. * Current or pending worker's compensation, litigation, disability, or any other monetary settlement regarding his/her CLBP or any other pain condition, or any closed claim within the past 5 years. * Use of any analgesic or muscle relaxant within 48 hours prior to the five days before Baseline * Patients receiving only acetaminophen, gabapentin or pregabalin to manage their chronic low back pain. * Patients taking \>325 mg/day of aspirin. * Use of any antidepressants with the exception of stable treatment with selective serotonin reuptake inhibitors (SSRIs). * Use of any sedatives/hypnotics, anxiolytics, tranquilizers, or benzodiazepines unless daily dose has been stable and will remain unchanged throughout the study period. * Systemic corticosteroid therapy within 30 days (inhaled and topical corticosteroids are permitted). * Local or epidural injection of corticosteroids, as well as injections of corticosteroids in the back within 3 months. * Botulinum toxin (Botox®) injection for chronic low back pain within 4 months. * Requirement for new, concomitant physiotherapy including, but not limited to, transdermal electroneural stimulation (TENS), massage or spinal manipulation for the duration of the study period. * Active or suspected esophageal, gastric, pyloric channel, or duodenal ulceration within 3 months, or any history of gastrointestinal bleeding. * Current use of lithium or anticoagulant agents. * Known hypersensitivity or intolerance to NSAIDs; history of asthma, urticaria, or allergic type reactions after taking aspirin or NSAIDs. * Inflammatory bowel disease, a chronic or acute renal or hepatic disorder, a significant coagulation defect, or other condition that might preclude the use of an NSAID. * History of intolerance to acetaminophen or paracetamol or any of its excipients. * History of known alcohol, analgesic or narcotic abuse within 2 years. * Presence of drugs of abuse (including prescription medications without a valid prescription), other illegal drugs or marijuana in the urine toxicology screen obtained at Screening. * History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG fusion protein. * Use of biologics other than study medication, including any live vaccines, within 3 months, or use during the study (intranasal Flumist® vaccine is an exception). * Signs and symptoms of clinically significant cardiac disease. * Diagnosis of a transient ischemic attack within the 6 months, or residual deficits from stroke that would preclude completion of required study activities. * History of cancer within 5 years. * Use of any investigational medication within 30 days (3 months for investigational biologics). * Expected to undergo a therapeutic procedure or to use any analgesic other than those specified in the protocol throughout the study period. * Previous exposure to exogenous NGF or to an anti NGF antibody. * Screening laboratory results and blood pressure within specified limits. * Positive Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV) tests at screening. * History, diagnosis, or signs and symptoms of clinically significant neurological disease. * History, diagnosis, signs or symptoms of any clinically significant psychiatric disorder. * Hospital admission for depression or suicide attempt within 5 years or active, severe major depression at Screening. * Likelihood of being non compliant with study procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 16: Baseline Observation Carried Forward (BOCF) | Baseline, Week 16 | Daily average back pain was assessed on an 11-point numeric rating scale (NRS) captured through an interactive voice response system (IVRS). The participant described the chronic low back pain (CLBP) 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 days prior to randomization (initial pain assessment period). Post-baseline value was calculated as mean of the scores over the 7-day period prior to and including the post-baseline visit. Overall possible score range for daily average LBPI at specified visit was 0= no pain to 10= worst possible pain, where higher scores indicated higher pain intensity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Baseline, Week 2, 4, 8, 12, 16 | Participants answered: Considering all ways your low back pain affects you, how are you doing today? Participants rated their condition using scale assessing symptoms and limitations to carry out normal daily activities. Score range:1 to 5. 1: Very Good (No symptoms and limitations); 2: Good (Mild symptoms and no limitations); 3: Fair (Moderate symptoms and some limitations); 4: Poor (Severe symptoms and inability to carry out most activities); 5: Very Poor (Very severe, intolerable symptoms and inability to carry all activities). |
| Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF) | Baseline, Week 2, 4, 8, 12 | Daily average back pain was assessed on an 11-point numeric rating scale (NRS) captured through an interactive voice response system (IVRS). The participant described the chronic low back pain (CLBP) 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 days prior to randomization (initial pain assessment period). Post-baseline value was calculated as mean of the scores over the 7-day period prior to and including the post-baseline visit. |
| Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | Baseline, Week 16 | Daily average back pain was assessed on an 11-point numeric rating scale (NRS) captured through an interactive voice response system (IVRS). The participant described the chronic low back pain (CLBP) 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 days prior to randomization (initial pain assessment period). Post-baseline value was calculated as mean of the scores over the 7-day period prior to and including the post-baseline visit. Participants with specified reduction (as percent) from baseline at Week 16 are reported. |
| Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Baseline, Week 2, 4, 8, 12, 16 | Daily average back pain was assessed on an 11-point numeric rating scale (NRS) captured through an interactive voice response system (IVRS). The participant described the chronic low back pain (CLBP) 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 days prior to randomization (initial pain assessment period). Post-baseline value was calculated as mean of the scores over the 7-day period prior to and including the post-baseline visit. |
| Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Baseline, Week 2, 4, 8, 12, 16 | BPI-sf: self-report questionnaire rated on an 11-point scale, consists of 5 questions to assess severity and impact of pain on daily functions. Question 1-4 (Q1-Q4) measure severity of pain (worst, least, average, right now), each question ranging between 0 (no pain) to 10 (pain as bad as you can imagine). Question 5 (Q5) consists of 7 items which measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life), each item ranging from 0 (does not interfere) to 10 (completely interferes). Results are reported for worst and average pain, each with a score range: 0 (no pain) and 10 (pain as bad as you can imagine), higher scores indicated worse pain. |
| Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Baseline, Week 2, 4, 8, 12, 16 | BPI-sf: self-report questionnaire rated on an 11-point scale, consists of 5 questions to assess severity and impact of pain on daily functions. Question 1-4 (Q1-Q4) measure severity of pain (worst, least, average, right now), each question ranging between 0 (no pain) to 10 (pain as bad as you can imagine). Question 5 (Q5) consists of 7 items which measure pain interference (PI) on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life), each item ranging from 0 (does not interfere) to 10 (completely interferes); higher score = greater impairment. The 7 items in Q5 averaged to obtain pain interference index (function composite score), range: 0 (no interference) to 10 (complete interference); higher score = greater impairment. |
| Time to Discontinuation Due to Lack of Efficacy | Baseline up to Week 16 | Median time to discontinuation due to lack of efficacy was estimated using Kaplan-Meier method. |
| Number of Participants With Chronic Low Back Pain (CLBP) Responder Index: Baseline Observation Carried Forward (BOCF) | Week 2, 4, 8, 12, 16 | Chronic Low Back Pain (CLBP) Responder Index: A response was defined as reduction of at least 30% in mean daily average LBPI from baseline to a specified week, decrease of at least 30% in PGA of low back pain from baseline to the specified week and no worsening (increase) in RMDQ total score from baseline to the specified week. Participants who were responders were reported. |
| Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Baseline, Week 2, 4, 8, 12, 16 | RMDQ: back-specific, participant administered questionnaire that assesses how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement if it describes his/her functional ability on the day of assessment. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements marked. Total possible RMDQ score: 0 (best functioning) to 24 (worst functioning), with higher scores indicated greater disability. |
| Percentage of Participants Who Used Rescue Medications | Week 2, 4, 8, 12, 16 | In case of inadequate pain relief for CLBP or for non-CLBP related pain, acetaminophen up to 3000 mg per day up to 3 days per week could be taken as rescue medication. |
| Duration of Rescue Medication Use | Week 2, 4, 8, 12, 16 | In case of inadequate pain relief for CLBP or for non-CLBP related pain, acetaminophen up to 3000 mg per day up to 3 days per week could be taken as rescue medication. |
| Amount of Rescue Medication Taken | Week 2, 4, 8, 12, 16 | In case of inadequate pain relief for CLBP or for non-CLBP related pain, acetaminophen up to 3000 mg per day up to 3 days per week could be taken as rescue medication. |
| Change From Baseline Neuropathy Impairment Score (NIS) at Week 8, 16 and 24 | Baseline, Week 8, 16, 24 | NIS is a standardized instrument used to evaluate signs of peripheral neuropathy in participants. NIS is the sum of scores of 37 items, from both the left and right side of following 4 domains: cranial nerves (5 items), muscle weakness (19 items), reflexes (5 items) and sensation (8 items). Each of 24 items related to cranial nerves and muscle weakness, scored from 0 (normal) to 4 (paralysis); higher scores indicated higher abnormality/impairment. Each of 13 items related to reflexes and sensation, scored as 0 (normal), 1 (decreased) and 2 (absent); higher scores indicated lesser reflexes and sensation. For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits. |
| Number of Participants Who Developed Anti-Tanezumab Antibodies | Baseline (Day 1), Week 8, 16, 24 | 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). Same participant may have positive ADA result at more than 1 time point. |
| Plasma Concentration of Tanezumab | Baseline (pre-dose and 1 hour [hr] post-dose); Any time point at Week 4 Visit; Week 8 (pre-dose and 1 hr post-dose); Any time point at Week 16 Visit, at Week 24 Visit | Analysis was done by setting concentration values below the lower limit of quantification (LLOQ) to zero. |
| Total Nerve Growth Factor (NGF) Concentration | Baseline (pre-dose and 1 hour [hr] post-dose); Any time point at Week 4 Visit; Week 8 (pre-dose and 1 hr post-dose); Any time point at Week 16 Visit, at Week 24 Visit | — |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to Week 24 | 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 Week 24 that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial. |
| Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Baseline, Week 8, 16 | WPAI:SHP is a self-administered questionnaire that measures the effect of general health and symptom severity on work productivity and regular activities. Four scores are derived as percent: activity impairment (AI), impairment while working (IW), overall work impairment (OWI), work time missed (WTM). Each of 4 scores expressed as impairment percentages with a total possible score range of 0 to 100, high percentage= more impairment, less productivity. |
Countries
United States
Participant flow
Recruitment details
Participants underwent for a 5-day initial pain assessment period prior to randomization.
Pre-assignment details
Participants who discontinued due to lack of efficacy or completed the treatment in this study were eligible to enroll in safety extension study A4091039 (NCT00924664).
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16. | 230 |
| Tanezumab 5 mg Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16. | 232 |
| Tanezumab 10 mg Tanezumab (RN624 or PF-04383119)10 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16. | 295 |
| Tanezumab 20 mg Tanezumab (RN624 or PF-04383119) 20 mg intravenous infusion over a 5-minute period at Day 1 and Week 8 along with placebo matched to naproxen tablet orally twice daily up to Week 16. | 295 |
| Naproxen 500 mg Naproxen 500 mg tablet orally twice daily up to Week 16 along with placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over a 5-minute period at Day 1 and Week 8. | 295 |
| Total | 1,347 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 14 | 12 | 19 | 29 | 10 |
| Overall Study | Entered extension study | 101 | 120 | 156 | 151 | 144 |
| Overall Study | Lack of Efficacy | 59 | 34 | 45 | 34 | 59 |
| Overall Study | Lost to Follow-up | 9 | 10 | 8 | 8 | 11 |
| Overall Study | Other | 2 | 5 | 9 | 7 | 4 |
| Overall Study | Protocol Violation | 6 | 7 | 7 | 6 | 3 |
| Overall Study | Randomized but not treated | 3 | 1 | 3 | 2 | 3 |
| Overall Study | Withdrawal by Subject | 16 | 26 | 32 | 38 | 37 |
Baseline characteristics
| Characteristic | Placebo | Tanezumab 5 mg | Tanezumab 10 mg | Tanezumab 20 mg | Naproxen 500 mg | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 51.2 years STANDARD_DEVIATION 13.2 | 51.5 years STANDARD_DEVIATION 14.2 | 52.0 years STANDARD_DEVIATION 13.9 | 51.2 years STANDARD_DEVIATION 12.9 | 52.6 years STANDARD_DEVIATION 13.2 | 51.8 years STANDARD_DEVIATION 13.5 |
| Sex: Female, Male Female | 125 Participants | 115 Participants | 157 Participants | 165 Participants | 152 Participants | 714 Participants |
| Sex: Female, Male Male | 105 Participants | 117 Participants | 138 Participants | 130 Participants | 143 Participants | 633 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 74 / 230 | 80 / 232 | 114 / 295 | 134 / 295 | 76 / 295 |
| serious Total, serious adverse events | 5 / 230 | 4 / 232 | 3 / 295 | 3 / 295 | 5 / 295 |
Outcome results
Primary
Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 16: Baseline Observation Carried Forward (BOCF)
Daily average back pain was assessed on an 11-point numeric rating scale (NRS) captured through an interactive voice response system (IVRS). The participant described the chronic low back pain (CLBP) 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 days prior to randomization (initial pain assessment period). Post-baseline value was calculated as mean of the scores over the 7-day period prior to and including the post-baseline visit. Overall possible score range for daily average LBPI at specified visit was 0= no pain to 10= worst possible pain, where higher scores indicated higher pain intensity.
Time frame: Baseline, Week 16
Population: ITT analysis set included all participants who received at least 1 dose of intravenous study medication. BOCF method was used to impute missing values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 16: Baseline Observation Carried Forward (BOCF) | Baseline | 6.71 units on a scale | Standard Deviation 1.37 |
| Placebo | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 16: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -1.25 units on a scale | Standard Deviation 2.01 |
| Tanezumab 5 mg | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 16: Baseline Observation Carried Forward (BOCF) | Baseline | 6.62 units on a scale | Standard Deviation 1.36 |
| Tanezumab 5 mg | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 16: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -1.55 units on a scale | Standard Deviation 2.07 |
| Tanezumab 10 mg | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 16: Baseline Observation Carried Forward (BOCF) | Baseline | 6.57 units on a scale | Standard Deviation 1.39 |
| Tanezumab 10 mg | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 16: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -2.02 units on a scale | Standard Deviation 2.4 |
| Tanezumab 20 mg | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 16: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -2.19 units on a scale | Standard Deviation 2.52 |
| Tanezumab 20 mg | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 16: Baseline Observation Carried Forward (BOCF) | Baseline | 6.74 units on a scale | Standard Deviation 1.48 |
| Naproxen 500 mg | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 16: Baseline Observation Carried Forward (BOCF) | Baseline | 6.77 units on a scale | Standard Deviation 1.38 |
| Naproxen 500 mg | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 16: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -1.70 units on a scale | Standard Deviation 2.28 |
Comparison: Treatment difference and 95 percent (%) confidence interval (CI) was based on least squares (LS) mean. Analysis of Covariance (ANCOVA) was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.11395% CI: [-0.74, 0.08]ANCOVA
Comparison: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-1.19, -0.42]ANCOVA
Comparison: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-1.31, -0.54]ANCOVA
Comparison: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.68895% CI: [-0.31, 0.47]ANCOVA
Comparison: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.03595% CI: [-0.76, -0.03]ANCOVA
Comparison: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.00695% CI: [-0.88, -0.15]ANCOVA
Secondary
Amount of Rescue Medication Taken
In case of inadequate pain relief for CLBP or for non-CLBP related pain, acetaminophen up to 3000 mg per day up to 3 days per week could be taken as rescue medication.
Time frame: Week 2, 4, 8, 12, 16
Population: ITT analysis set. LOCF method was used to impute missing values. 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 outcome measure at given time points for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Amount of Rescue Medication Taken | Week 2 | 4168.12 mg per week | Standard Deviation 4708.74 |
| Placebo | Amount of Rescue Medication Taken | Week 4 | 3547.83 mg per week | Standard Deviation 4860.04 |
| Placebo | Amount of Rescue Medication Taken | Week 8 | 2910.87 mg per week | Standard Deviation 4483.8 |
| Placebo | Amount of Rescue Medication Taken | Week 16 | 2523.91 mg per week | Standard Deviation 4493.14 |
| Placebo | Amount of Rescue Medication Taken | Week 12 | 2619.57 mg per week | Standard Deviation 5350.37 |
| Tanezumab 5 mg | Amount of Rescue Medication Taken | Week 2 | 4305.19 mg per week | Standard Deviation 5102.74 |
| Tanezumab 5 mg | Amount of Rescue Medication Taken | Week 4 | 3252.16 mg per week | Standard Deviation 5189.48 |
| Tanezumab 5 mg | Amount of Rescue Medication Taken | Week 12 | 2256.47 mg per week | Standard Deviation 4350.69 |
| Tanezumab 5 mg | Amount of Rescue Medication Taken | Week 8 | 2633.62 mg per week | Standard Deviation 4309.14 |
| Tanezumab 5 mg | Amount of Rescue Medication Taken | Week 16 | 2140.09 mg per week | Standard Deviation 4167.33 |
| Tanezumab 10 mg | Amount of Rescue Medication Taken | Week 12 | 2511.95 mg per week | Standard Deviation 4164.31 |
| Tanezumab 10 mg | Amount of Rescue Medication Taken | Week 8 | 2829.35 mg per week | Standard Deviation 4458.51 |
| Tanezumab 10 mg | Amount of Rescue Medication Taken | Week 2 | 3952.22 mg per week | Standard Deviation 4527.82 |
| Tanezumab 10 mg | Amount of Rescue Medication Taken | Week 4 | 2583.62 mg per week | Standard Deviation 3966.56 |
| Tanezumab 10 mg | Amount of Rescue Medication Taken | Week 16 | 2250.85 mg per week | Standard Deviation 3979.75 |
| Tanezumab 20 mg | Amount of Rescue Medication Taken | Week 4 | 2688.36 mg per week | Standard Deviation 4314.58 |
| Tanezumab 20 mg | Amount of Rescue Medication Taken | Week 16 | 2369.86 mg per week | Standard Deviation 4417.07 |
| Tanezumab 20 mg | Amount of Rescue Medication Taken | Week 8 | 2558.22 mg per week | Standard Deviation 4232.71 |
| Tanezumab 20 mg | Amount of Rescue Medication Taken | Week 2 | 4306.90 mg per week | Standard Deviation 4880.47 |
| Tanezumab 20 mg | Amount of Rescue Medication Taken | Week 12 | 2351.03 mg per week | Standard Deviation 4297.87 |
| Naproxen 500 mg | Amount of Rescue Medication Taken | Week 16 | 2448.98 mg per week | Standard Deviation 4677.93 |
| Naproxen 500 mg | Amount of Rescue Medication Taken | Week 4 | 2680.89 mg per week | Standard Deviation 4120.78 |
| Naproxen 500 mg | Amount of Rescue Medication Taken | Week 8 | 2477.89 mg per week | Standard Deviation 4270.55 |
| Naproxen 500 mg | Amount of Rescue Medication Taken | Week 12 | 2455.78 mg per week | Standard Deviation 4580.69 |
| Naproxen 500 mg | Amount of Rescue Medication Taken | Week 2 | 3350.52 mg per week | Standard Deviation 4564.2 |
Secondary
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF
BPI-sf: self-report questionnaire rated on an 11-point scale, consists of 5 questions to assess severity and impact of pain on daily functions. Question 1-4 (Q1-Q4) measure severity of pain (worst, least, average, right now), each question ranging between 0 (no pain) to 10 (pain as bad as you can imagine). Question 5 (Q5) consists of 7 items which measure pain interference (PI) on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life), each item ranging from 0 (does not interfere) to 10 (completely interferes); higher score = greater impairment. The 7 items in Q5 averaged to obtain pain interference index (function composite score), range: 0 (no interference) to 10 (complete interference); higher score = greater impairment.
Time frame: Baseline, Week 2, 4, 8, 12, 16
Population: ITT analysis set. BOCF method was used to impute missing values. Here, Overall number of participants analyzed = participants who were evaluable for this outcome measure and 'Number Analyzed' = participants who were evaluable for this outcome measure at given time points for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 16: Pain Interference with Sleep | -1.4 units on a scale | Standard Deviation 2.29 |
| Placebo | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 16: General Activity | -1.34 units on a scale | Standard Deviation 2.21 |
| Placebo | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 16: Normal Work | -1.27 units on a scale | Standard Deviation 2.15 |
| Placebo | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 8: Pain Interference Index | -1.33 units on a scale | Standard Deviation 2.2 |
| Placebo | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 4: Pain Interference Index | -1.48 units on a scale | Standard Deviation 2.19 |
| Placebo | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 12: Walking Ability | -1.28 units on a scale | Standard Deviation 2.41 |
| Placebo | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 12: Normal Work | -1.43 units on a scale | Standard Deviation 2.25 |
| Placebo | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 2: Walking Ability | -1.29 units on a scale | Standard Deviation 2.71 |
| Placebo | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 2: General Activity | -1.30 units on a scale | Standard Deviation 2.58 |
| Placebo | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 16: Walking Ability | -1.17 units on a scale | Standard Deviation 2.16 |
| Placebo | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 2: Pain Interference Index | -1.33 units on a scale | Standard Deviation 2.2 |
| Placebo | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 8: Normal Work | -1.31 units on a scale | Standard Deviation 2.35 |
| Placebo | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 4: Pain Interference with Sleep | -1.6 units on a scale | Standard Deviation 2.52 |
| Placebo | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 4: General Activity | -1.33 units on a scale | Standard Deviation 2.55 |
| Placebo | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 12: Pain Interference Index | -1.38 units on a scale | Standard Deviation 2.19 |
| Placebo | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 8: Pain Interference with Sleep | -1.4 units on a scale | Standard Deviation 2.54 |
| Placebo | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 4: Normal Work | -1.59 units on a scale | Standard Deviation 2.36 |
| Placebo | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 8: General Activity | -1.36 units on a scale | Standard Deviation 2.57 |
| Placebo | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 12: Pain Interference with Sleep | -1.5 units on a scale | Standard Deviation 2.49 |
| Placebo | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 8: Walking Ability | -1.24 units on a scale | Standard Deviation 2.56 |
| Placebo | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 2: Pain Interference with Sleep | -1.4 units on a scale | Standard Deviation 2.72 |
| Placebo | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 2: Normal Work | -1.33 units on a scale | Standard Deviation 2.37 |
| Placebo | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 12: General Activity | -1.43 units on a scale | Standard Deviation 2.54 |
| Placebo | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 16: Pain Interference Index | -1.32 units on a scale | Standard Deviation 2.01 |
| Placebo | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 4: Walking Ability | -1.48 units on a scale | Standard Deviation 2.71 |
| Tanezumab 5 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 8: Pain Interference with Sleep | -1.9 units on a scale | Standard Deviation 2.62 |
| Tanezumab 5 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 16: General Activity | -1.68 units on a scale | Standard Deviation 2.55 |
| Tanezumab 5 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 12: Walking Ability | -1.63 units on a scale | Standard Deviation 2.5 |
| Tanezumab 5 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 2: Walking Ability | -1.59 units on a scale | Standard Deviation 2.52 |
| Tanezumab 5 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 8: Walking Ability | -1.62 units on a scale | Standard Deviation 2.47 |
| Tanezumab 5 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 4: Walking Ability | -1.91 units on a scale | Standard Deviation 2.59 |
| Tanezumab 5 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 4: Pain Interference Index | -1.99 units on a scale | Standard Deviation 2.12 |
| Tanezumab 5 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 12: Pain Interference with Sleep | -1.8 units on a scale | Standard Deviation 2.69 |
| Tanezumab 5 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 4: Pain Interference with Sleep | -2.3 units on a scale | Standard Deviation 2.62 |
| Tanezumab 5 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 12: Pain Interference Index | -1.62 units on a scale | Standard Deviation 2.21 |
| Tanezumab 5 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 2: Pain Interference with Sleep | -1.7 units on a scale | Standard Deviation 2.58 |
| Tanezumab 5 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 16: Pain Interference Index | -1.52 units on a scale | Standard Deviation 2.19 |
| Tanezumab 5 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 16: Normal Work | -1.55 units on a scale | Standard Deviation 2.45 |
| Tanezumab 5 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 8: Pain Interference Index | -1.65 units on a scale | Standard Deviation 2.16 |
| Tanezumab 5 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 12: Normal Work | -1.76 units on a scale | Standard Deviation 2.43 |
| Tanezumab 5 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 8: Normal Work | -1.72 units on a scale | Standard Deviation 2.46 |
| Tanezumab 5 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 2: General Activity | -1.72 units on a scale | Standard Deviation 2.51 |
| Tanezumab 5 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 4: Normal Work | -2.03 units on a scale | Standard Deviation 2.49 |
| Tanezumab 5 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 4: General Activity | -2.17 units on a scale | Standard Deviation 2.42 |
| Tanezumab 5 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 2: Pain Interference Index | -1.59 units on a scale | Standard Deviation 2.14 |
| Tanezumab 5 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 8: General Activity | -1.70 units on a scale | Standard Deviation 2.52 |
| Tanezumab 5 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 16: Pain Interference with Sleep | -1.7 units on a scale | Standard Deviation 2.66 |
| Tanezumab 5 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 2: Normal Work | -1.75 units on a scale | Standard Deviation 2.57 |
| Tanezumab 5 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 12: General Activity | -1.76 units on a scale | Standard Deviation 2.54 |
| Tanezumab 5 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 16: Walking Ability | -1.49 units on a scale | Standard Deviation 2.29 |
| Tanezumab 10 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 8: Pain Interference Index | -2.15 units on a scale | Standard Deviation 2.34 |
| Tanezumab 10 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 2: Walking Ability | -1.83 units on a scale | Standard Deviation 2.69 |
| Tanezumab 10 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 4: Normal Work | -2.49 units on a scale | Standard Deviation 2.57 |
| Tanezumab 10 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 12: Pain Interference with Sleep | -2.4 units on a scale | Standard Deviation 3.04 |
| Tanezumab 10 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 2: Pain Interference Index | -1.97 units on a scale | Standard Deviation 2.33 |
| Tanezumab 10 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 4: Pain Interference Index | -2.40 units on a scale | Standard Deviation 2.31 |
| Tanezumab 10 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 12: Pain Interference Index | -2.21 units on a scale | Standard Deviation 2.47 |
| Tanezumab 10 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 16: Pain Interference Index | -2.02 units on a scale | Standard Deviation 2.48 |
| Tanezumab 10 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 2: General Activity | -2.20 units on a scale | Standard Deviation 2.75 |
| Tanezumab 10 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 4: General Activity | -2.64 units on a scale | Standard Deviation 2.59 |
| Tanezumab 10 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 8: General Activity | -2.27 units on a scale | Standard Deviation 2.63 |
| Tanezumab 10 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 12: General Activity | -2.39 units on a scale | Standard Deviation 2.73 |
| Tanezumab 10 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 16: General Activity | -2.20 units on a scale | Standard Deviation 2.76 |
| Tanezumab 10 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 4: Walking Ability | -2.32 units on a scale | Standard Deviation 2.59 |
| Tanezumab 10 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 8: Walking Ability | -2.01 units on a scale | Standard Deviation 2.66 |
| Tanezumab 10 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 12: Walking Ability | -2.13 units on a scale | Standard Deviation 2.68 |
| Tanezumab 10 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 16: Walking Ability | -1.91 units on a scale | Standard Deviation 2.71 |
| Tanezumab 10 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 2: Normal Work | -2.01 units on a scale | Standard Deviation 2.61 |
| Tanezumab 10 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 8: Normal Work | -2.25 units on a scale | Standard Deviation 2.64 |
| Tanezumab 10 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 12: Normal Work | -2.35 units on a scale | Standard Deviation 2.75 |
| Tanezumab 10 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 16: Normal Work | -2.09 units on a scale | Standard Deviation 2.74 |
| Tanezumab 10 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 2: Pain Interference with Sleep | -2.0 units on a scale | Standard Deviation 2.89 |
| Tanezumab 10 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 4: Pain Interference with Sleep | -2.6 units on a scale | Standard Deviation 2.87 |
| Tanezumab 10 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 8: Pain Interference with Sleep | -2.4 units on a scale | Standard Deviation 2.86 |
| Tanezumab 10 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 16: Pain Interference with Sleep | -2.3 units on a scale | Standard Deviation 3.04 |
| Tanezumab 20 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 2: General Activity | -2.06 units on a scale | Standard Deviation 3 |
| Tanezumab 20 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 2: Normal Work | -2.01 units on a scale | Standard Deviation 2.9 |
| Tanezumab 20 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 12: Pain Interference Index | -2.38 units on a scale | Standard Deviation 2.6 |
| Tanezumab 20 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 12: Pain Interference with Sleep | -2.5 units on a scale | Standard Deviation 3 |
| Tanezumab 20 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 2: Pain Interference with Sleep | -1.7 units on a scale | Standard Deviation 3.09 |
| Tanezumab 20 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 8: Normal Work | -2.58 units on a scale | Standard Deviation 2.75 |
| Tanezumab 20 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 8: Pain Interference Index | -2.37 units on a scale | Standard Deviation 2.45 |
| Tanezumab 20 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 4: Pain Interference Index | -2.63 units on a scale | Standard Deviation 2.44 |
| Tanezumab 20 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 16: Walking Ability | -2.14 units on a scale | Standard Deviation 2.72 |
| Tanezumab 20 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 4: Pain Interference with Sleep | -2.7 units on a scale | Standard Deviation 2.89 |
| Tanezumab 20 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 4: General Activity | -2.90 units on a scale | Standard Deviation 2.84 |
| Tanezumab 20 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 12: Normal Work | -2.57 units on a scale | Standard Deviation 2.85 |
| Tanezumab 20 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 2: Pain Interference Index | -1.81 units on a scale | Standard Deviation 2.63 |
| Tanezumab 20 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 16: Pain Interference with Sleep | -2.3 units on a scale | Standard Deviation 2.82 |
| Tanezumab 20 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 4: Walking Ability | -2.58 units on a scale | Standard Deviation 2.88 |
| Tanezumab 20 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 8: General Activity | -2.53 units on a scale | Standard Deviation 2.76 |
| Tanezumab 20 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 2: Walking Ability | -1.81 units on a scale | Standard Deviation 2.94 |
| Tanezumab 20 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 8: Pain Interference with Sleep | -2.4 units on a scale | Standard Deviation 2.83 |
| Tanezumab 20 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 4: Normal Work | -2.79 units on a scale | Standard Deviation 2.75 |
| Tanezumab 20 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 16: Pain Interference Index | -2.17 units on a scale | Standard Deviation 2.44 |
| Tanezumab 20 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 16: General Activity | -2.26 units on a scale | Standard Deviation 2.71 |
| Tanezumab 20 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 8: Walking Ability | -2.36 units on a scale | Standard Deviation 2.88 |
| Tanezumab 20 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 12: Walking Ability | -2.34 units on a scale | Standard Deviation 2.82 |
| Tanezumab 20 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 16: Normal Work | -2.40 units on a scale | Standard Deviation 2.76 |
| Tanezumab 20 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 12: General Activity | -2.62 units on a scale | Standard Deviation 2.87 |
| Naproxen 500 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 12: General Activity | -1.90 units on a scale | Standard Deviation 2.68 |
| Naproxen 500 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 8: Normal Work | -1.76 units on a scale | Standard Deviation 2.49 |
| Naproxen 500 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 16: Walking Ability | -1.53 units on a scale | Standard Deviation 2.52 |
| Naproxen 500 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 8: General Activity | -1.77 units on a scale | Standard Deviation 2.64 |
| Naproxen 500 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 2: Normal Work | -1.67 units on a scale | Standard Deviation 2.67 |
| Naproxen 500 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 2: General Activity | -1.92 units on a scale | Standard Deviation 2.72 |
| Naproxen 500 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 4: Normal Work | -2.03 units on a scale | Standard Deviation 2.55 |
| Naproxen 500 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 8: Pain Interference Index | -1.71 units on a scale | Standard Deviation 2.22 |
| Naproxen 500 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 4: General Activity | -2.08 units on a scale | Standard Deviation 2.72 |
| Naproxen 500 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 12: Pain Interference with Sleep | -2.0 units on a scale | Standard Deviation 2.66 |
| Naproxen 500 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 12: Normal Work | -1.85 units on a scale | Standard Deviation 2.65 |
| Naproxen 500 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 16: Pain Interference Index | -1.59 units on a scale | Standard Deviation 2.28 |
| Naproxen 500 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 16: Normal Work | -1.65 units on a scale | Standard Deviation 2.47 |
| Naproxen 500 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 12: Pain Interference Index | -1.81 units on a scale | Standard Deviation 2.39 |
| Naproxen 500 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 4: Walking Ability | -2.00 units on a scale | Standard Deviation 2.63 |
| Naproxen 500 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 2: Pain Interference with Sleep | -2.2 units on a scale | Standard Deviation 2.9 |
| Naproxen 500 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 4: Pain Interference Index | -2.01 units on a scale | Standard Deviation 2.34 |
| Naproxen 500 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 16: Pain Interference with Sleep | -1.8 units on a scale | Standard Deviation 2.6 |
| Naproxen 500 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 4: Pain Interference with Sleep | -2.2 units on a scale | Standard Deviation 2.72 |
| Naproxen 500 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 2: Pain Interference Index | -1.75 units on a scale | Standard Deviation 2.46 |
| Naproxen 500 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 2: Walking Ability | -1.73 units on a scale | Standard Deviation 2.71 |
| Naproxen 500 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 8: Walking Ability | -1.72 units on a scale | Standard Deviation 2.52 |
| Naproxen 500 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 16: General Activity | -1.65 units on a scale | Standard Deviation 2.56 |
| Naproxen 500 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 8: Pain Interference with Sleep | -1.9 units on a scale | Standard Deviation 2.54 |
| Naproxen 500 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Change at Week 12: Walking Ability | -1.80 units on a scale | Standard Deviation 2.55 |
Secondary
Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF)
BPI-sf: self-report questionnaire rated on an 11-point scale, consists of 5 questions to assess severity and impact of pain on daily functions. Question 1-4 (Q1-Q4) measure severity of pain (worst, least, average, right now), each question ranging between 0 (no pain) to 10 (pain as bad as you can imagine). Question 5 (Q5) consists of 7 items which measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life), each item ranging from 0 (does not interfere) to 10 (completely interferes). Results are reported for worst and average pain, each with a score range: 0 (no pain) and 10 (pain as bad as you can imagine), higher scores indicated worse pain.
Time frame: Baseline, Week 2, 4, 8, 12, 16
Population: ITT analysis set included all participants who received at least 1 dose of intravenous study medication. BOCF method was used to impute missing values. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Change at Week 8: Worst Pain | -1.54 units on a scale | Standard Deviation 2.33 |
| Placebo | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Change at Week 16: Worst Pain | -1.55 units on a scale | Standard Deviation 2.35 |
| Placebo | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Baseline: Average Pain | 6.22 units on a scale | Standard Deviation 1.44 |
| Placebo | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Change at Week 2: Average Pain | -1.16 units on a scale | Standard Deviation 1.93 |
| Placebo | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Change at Week 8: Average Pain | -1.19 units on a scale | Standard Deviation 1.93 |
| Placebo | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Baseline: Worst Pain | 7.27 units on a scale | Standard Deviation 1.51 |
| Placebo | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Average Pain | -1.32 units on a scale | Standard Deviation 2.12 |
| Placebo | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Change at Week 4: Average Pain | -1.19 units on a scale | Standard Deviation 1.95 |
| Placebo | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Change at Week 4: Worst Pain | -1.63 units on a scale | Standard Deviation 2.38 |
| Placebo | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Change at Week 2: Worst Pain | -1.63 units on a scale | Standard Deviation 2.33 |
| Placebo | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Change at Week 16: Average Pain | -1.20 units on a scale | Standard Deviation 1.95 |
| Placebo | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Worst Pain | -1.63 units on a scale | Standard Deviation 2.43 |
| Tanezumab 5 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Baseline: Worst Pain | 7.10 units on a scale | Standard Deviation 1.53 |
| Tanezumab 5 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Change at Week 4: Average Pain | -1.88 units on a scale | Standard Deviation 1.91 |
| Tanezumab 5 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Change at Week 8: Worst Pain | -1.94 units on a scale | Standard Deviation 2.3 |
| Tanezumab 5 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Baseline: Average Pain | 6.25 units on a scale | Standard Deviation 1.51 |
| Tanezumab 5 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Change at Week 2: Worst Pain | -1.76 units on a scale | Standard Deviation 2.14 |
| Tanezumab 5 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Change at Week 16: Worst Pain | -1.75 units on a scale | Standard Deviation 2.34 |
| Tanezumab 5 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Change at Week 8: Average Pain | -1.78 units on a scale | Standard Deviation 1.99 |
| Tanezumab 5 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Average Pain | -1.75 units on a scale | Standard Deviation 2.11 |
| Tanezumab 5 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Change at Week 2: Average Pain | -1.43 units on a scale | Standard Deviation 1.91 |
| Tanezumab 5 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Change at Week 16: Average Pain | -1.58 units on a scale | Standard Deviation 2.14 |
| Tanezumab 5 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Worst Pain | -1.99 units on a scale | Standard Deviation 2.41 |
| Tanezumab 5 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Change at Week 4: Worst Pain | -2.21 units on a scale | Standard Deviation 2.28 |
| Tanezumab 10 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Change at Week 16: Worst Pain | -2.20 units on a scale | Standard Deviation 2.66 |
| Tanezumab 10 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Baseline: Worst Pain | 7.04 units on a scale | Standard Deviation 1.49 |
| Tanezumab 10 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Baseline: Average Pain | 6.08 units on a scale | Standard Deviation 1.52 |
| Tanezumab 10 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Change at Week 2: Worst Pain | -2.19 units on a scale | Standard Deviation 2.41 |
| Tanezumab 10 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Change at Week 2: Average Pain | -1.69 units on a scale | Standard Deviation 2.11 |
| Tanezumab 10 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Change at Week 4: Worst Pain | -2.57 units on a scale | Standard Deviation 2.5 |
| Tanezumab 10 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Change at Week 4: Average Pain | -2.09 units on a scale | Standard Deviation 2.18 |
| Tanezumab 10 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Change at Week 8: Worst Pain | -2.35 units on a scale | Standard Deviation 2.45 |
| Tanezumab 10 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Change at Week 8: Average Pain | -1.98 units on a scale | Standard Deviation 2.18 |
| Tanezumab 10 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Worst Pain | -2.53 units on a scale | Standard Deviation 2.73 |
| Tanezumab 10 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Average Pain | -2.13 units on a scale | Standard Deviation 2.35 |
| Tanezumab 10 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Change at Week 16: Average Pain | -1.89 units on a scale | Standard Deviation 2.37 |
| Tanezumab 20 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Change at Week 4: Average Pain | -2.32 units on a scale | Standard Deviation 2.34 |
| Tanezumab 20 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Baseline: Worst Pain | 7.36 units on a scale | Standard Deviation 1.59 |
| Tanezumab 20 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Change at Week 8: Average Pain | -2.18 units on a scale | Standard Deviation 2.42 |
| Tanezumab 20 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Change at Week 4: Worst Pain | -2.88 units on a scale | Standard Deviation 2.64 |
| Tanezumab 20 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Worst Pain | -2.70 units on a scale | Standard Deviation 2.84 |
| Tanezumab 20 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Change at Week 2: Average Pain | -1.65 units on a scale | Standard Deviation 2.34 |
| Tanezumab 20 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Change at Week 16: Average Pain | -2.03 units on a scale | Standard Deviation 2.47 |
| Tanezumab 20 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Average Pain | -2.26 units on a scale | Standard Deviation 2.54 |
| Tanezumab 20 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Change at Week 2: Worst Pain | -2.08 units on a scale | Standard Deviation 2.6 |
| Tanezumab 20 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Baseline: Average Pain | 6.35 units on a scale | Standard Deviation 1.45 |
| Tanezumab 20 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Change at Week 16: Worst Pain | -2.36 units on a scale | Standard Deviation 2.78 |
| Tanezumab 20 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Change at Week 8: Worst Pain | -2.55 units on a scale | Standard Deviation 2.7 |
| Naproxen 500 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Change at Week 4: Average Pain | -1.77 units on a scale | Standard Deviation 2.1 |
| Naproxen 500 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Average Pain | -1.73 units on a scale | Standard Deviation 2.13 |
| Naproxen 500 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Baseline: Worst Pain | 7.28 units on a scale | Standard Deviation 1.51 |
| Naproxen 500 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Change at Week 8: Average Pain | -1.61 units on a scale | Standard Deviation 1.97 |
| Naproxen 500 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Baseline: Average Pain | 6.27 units on a scale | Standard Deviation 1.41 |
| Naproxen 500 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Change at Week 2: Average Pain | -1.57 units on a scale | Standard Deviation 2.07 |
| Naproxen 500 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Change at Week 16: Average Pain | -1.66 units on a scale | Standard Deviation 2.19 |
| Naproxen 500 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Change at Week 4: Worst Pain | -2.16 units on a scale | Standard Deviation 2.5 |
| Naproxen 500 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Worst Pain | -2.13 units on a scale | Standard Deviation 2.55 |
| Naproxen 500 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Change at Week 8: Worst Pain | -1.98 units on a scale | Standard Deviation 2.31 |
| Naproxen 500 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Change at Week 2: Worst Pain | -1.97 units on a scale | Standard Deviation 2.38 |
| Naproxen 500 mg | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Change at Week 16: Worst Pain | -1.94 units on a scale | Standard Deviation 2.49 |
Secondary
Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)
Daily average back pain was assessed on an 11-point numeric rating scale (NRS) captured through an interactive voice response system (IVRS). The participant described the chronic low back pain (CLBP) 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 days prior to randomization (initial pain assessment period). Post-baseline value was calculated as mean of the scores over the 7-day period prior to and including the post-baseline visit.
Time frame: Baseline, Week 2, 4, 8, 12
Population: ITT analysis set included all participants who received at least 1 dose of intravenous study medication. BOCF method was used to impute missing values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -1.29 units on scale | Standard Deviation 1.84 |
| Placebo | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -1.50 units on scale | Standard Deviation 1.95 |
| Placebo | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -1.40 units on scale | Standard Deviation 2.05 |
| Placebo | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -1.49 units on scale | Standard Deviation 2.14 |
| Tanezumab 5 mg | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -1.48 units on scale | Standard Deviation 1.79 |
| Tanezumab 5 mg | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -1.92 units on scale | Standard Deviation 2.17 |
| Tanezumab 5 mg | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -1.94 units on scale | Standard Deviation 2 |
| Tanezumab 5 mg | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -1.82 units on scale | Standard Deviation 1.99 |
| Tanezumab 10 mg | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -2.27 units on scale | Standard Deviation 2.47 |
| Tanezumab 10 mg | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -2.47 units on scale | Standard Deviation 2.22 |
| Tanezumab 10 mg | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -2.23 units on scale | Standard Deviation 2.25 |
| Tanezumab 10 mg | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -1.83 units on scale | Standard Deviation 1.89 |
| Tanezumab 20 mg | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -1.68 units on scale | Standard Deviation 2.19 |
| Tanezumab 20 mg | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -2.44 units on scale | Standard Deviation 2.33 |
| Tanezumab 20 mg | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -2.37 units on scale | Standard Deviation 2.56 |
| Tanezumab 20 mg | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -2.32 units on scale | Standard Deviation 2.4 |
| Naproxen 500 mg | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -1.93 units on scale | Standard Deviation 2.29 |
| Naproxen 500 mg | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -1.82 units on scale | Standard Deviation 2.05 |
| Naproxen 500 mg | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -2.05 units on scale | Standard Deviation 2.05 |
| Naproxen 500 mg | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -1.85 units on scale | Standard Deviation 1.98 |
Comparison: Change at Week 2: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.22195% CI: [-0.57, 0.13]ANCOVA
Comparison: Change at Week 2: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-0.9, -0.24]ANCOVA
Comparison: Change at Week 2: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.02795% CI: [-0.7, -0.04]ANCOVA
Comparison: Change at Week 2: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.08295% CI: [-0.04, 0.62]ANCOVA
Comparison: Change at Week 2: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.70395% CI: [-0.37, 0.25]ANCOVA
Comparison: Change at Week 2: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.37995% CI: [-0.17, 0.45]ANCOVA
Comparison: Change at Week 4: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.01295% CI: [-0.87, -0.11]ANCOVA
Comparison: Change at Week 4: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-1.39, -0.67]ANCOVA
Comparison: Change at Week 4: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-1.31, -0.58]ANCOVA
Comparison: Change at Week 4: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.86295% CI: [-0.33, 0.39]ANCOVA
Comparison: Change at Week 4: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.00395% CI: [-0.85, -0.17]ANCOVA
Comparison: Change at Week 4: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.01495% CI: [-0.76, -0.09]ANCOVA
Comparison: Change at Week 8: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.01995% CI: [-0.86, -0.08]ANCOVA
Comparison: Change at Week 8: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-1.25, -0.51]ANCOVA
Comparison: Change at Week 8: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-1.29, -0.56]ANCOVA
Comparison: Change at Week 8: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.66895% CI: [-0.45, 0.29]ANCOVA
Comparison: Change at Week 8: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.00595% CI: [-0.84, -0.15]ANCOVA
Comparison: Change at Week 8: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.00295% CI: [-0.88, -0.19]ANCOVA
Comparison: Change at Week 12: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.03295% CI: [-0.89, -0.04]ANCOVA
Comparison: Change at Week 12: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-1.21, -0.41]ANCOVA
Comparison: Change at Week 12: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: <0.00195% CI: [-1.28, -0.48]ANCOVA
Comparison: Change at Week 12: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.77395% CI: [-0.46, 0.34]ANCOVA
Comparison: Change at Week 12: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.03595% CI: [-0.78, -0.03]ANCOVA
Comparison: Change at Week 12: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.p-value: 0.01495% CI: [-0.85, -0.1]ANCOVA
Secondary
Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
Participants answered: Considering all ways your low back pain affects you, how are you doing today? Participants rated their condition using scale assessing symptoms and limitations to carry out normal daily activities. Score range:1 to 5. 1: Very Good (No symptoms and limitations); 2: Good (Mild symptoms and no limitations); 3: Fair (Moderate symptoms and some limitations); 4: Poor (Severe symptoms and inability to carry out most activities); 5: Very Poor (Very severe, intolerable symptoms and inability to carry all activities).
Time frame: Baseline, Week 2, 4, 8, 12, 16
Population: ITT analysis set included all participants who received at least 1 dose of intravenous study medication. BOCF method was used to impute missing values. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -0.53 units on a scale | Standard Deviation 0.88 |
| Placebo | Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -0.42 units on a scale | Standard Deviation 0.78 |
| Placebo | Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -0.52 units on a scale | Standard Deviation 0.84 |
| Placebo | Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -0.48 units on a scale | Standard Deviation 0.82 |
| Placebo | Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -0.55 units on a scale | Standard Deviation 0.8 |
| Placebo | Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Baseline | 3.41 units on a scale | Standard Deviation 0.58 |
| Tanezumab 5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Baseline | 3.41 units on a scale | Standard Deviation 0.6 |
| Tanezumab 5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -0.78 units on a scale | Standard Deviation 0.89 |
| Tanezumab 5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -0.66 units on a scale | Standard Deviation 0.93 |
| Tanezumab 5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -0.62 units on a scale | Standard Deviation 0.91 |
| Tanezumab 5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -0.69 units on a scale | Standard Deviation 0.91 |
| Tanezumab 5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -0.59 units on a scale | Standard Deviation 0.96 |
| Tanezumab 10 mg | Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Baseline | 3.33 units on a scale | Standard Deviation 0.56 |
| Tanezumab 10 mg | Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -0.63 units on a scale | Standard Deviation 0.91 |
| Tanezumab 10 mg | Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -0.66 units on a scale | Standard Deviation 0.89 |
| Tanezumab 10 mg | Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -0.77 units on a scale | Standard Deviation 0.9 |
| Tanezumab 10 mg | Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -0.71 units on a scale | Standard Deviation 0.92 |
| Tanezumab 10 mg | Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -0.73 units on a scale | Standard Deviation 0.9 |
| Tanezumab 20 mg | Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -0.74 units on a scale | Standard Deviation 0.98 |
| Tanezumab 20 mg | Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -0.78 units on a scale | Standard Deviation 0.93 |
| Tanezumab 20 mg | Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Baseline | 3.36 units on a scale | Standard Deviation 0.56 |
| Tanezumab 20 mg | Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -0.67 units on a scale | Standard Deviation 0.93 |
| Tanezumab 20 mg | Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -0.84 units on a scale | Standard Deviation 0.95 |
| Tanezumab 20 mg | Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -0.62 units on a scale | Standard Deviation 1 |
| Naproxen 500 mg | Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -0.49 units on a scale | Standard Deviation 0.86 |
| Naproxen 500 mg | Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Baseline | 3.35 units on a scale | Standard Deviation 0.56 |
| Naproxen 500 mg | Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -0.59 units on a scale | Standard Deviation 0.84 |
| Naproxen 500 mg | Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -0.54 units on a scale | Standard Deviation 0.87 |
| Naproxen 500 mg | Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -0.59 units on a scale | Standard Deviation 0.86 |
| Naproxen 500 mg | Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -0.67 units on a scale | Standard Deviation 0.9 |
Secondary
Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
RMDQ: back-specific, participant administered questionnaire that assesses how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement if it describes his/her functional ability on the day of assessment. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements marked. Total possible RMDQ score: 0 (best functioning) to 24 (worst functioning), with higher scores indicated greater disability.
Time frame: Baseline, Week 2, 4, 8, 12, 16
Population: ITT analysis set included all participants who received at least 1 dose of intravenous study medication. BOCF method was used to impute missing values. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Baseline | 12.79 units on a scale | Standard Deviation 4.74 |
| Placebo | Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -1.68 units on a scale | Standard Deviation 3.74 |
| Placebo | Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -1.85 units on a scale | Standard Deviation 4.04 |
| Placebo | Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -1.86 units on a scale | Standard Deviation 4.13 |
| Placebo | Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -1.91 units on a scale | Standard Deviation 4.13 |
| Placebo | Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -1.76 units on a scale | Standard Deviation 4.15 |
| Tanezumab 5 mg | Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -2.23 units on a scale | Standard Deviation 3.82 |
| Tanezumab 5 mg | Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -2.27 units on a scale | Standard Deviation 4.07 |
| Tanezumab 5 mg | Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Baseline | 12.24 units on a scale | Standard Deviation 4.92 |
| Tanezumab 5 mg | Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -2.81 units on a scale | Standard Deviation 4.52 |
| Tanezumab 5 mg | Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -2.62 units on a scale | Standard Deviation 4.43 |
| Tanezumab 5 mg | Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -2.47 units on a scale | Standard Deviation 4.61 |
| Tanezumab 10 mg | Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -2.93 units on a scale | Standard Deviation 4.75 |
| Tanezumab 10 mg | Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -3.16 units on a scale | Standard Deviation 4.97 |
| Tanezumab 10 mg | Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Baseline | 12.98 units on a scale | Standard Deviation 5.11 |
| Tanezumab 10 mg | Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -3.45 units on a scale | Standard Deviation 4.9 |
| Tanezumab 10 mg | Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -2.59 units on a scale | Standard Deviation 4.41 |
| Tanezumab 10 mg | Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -3.20 units on a scale | Standard Deviation 5.07 |
| Tanezumab 20 mg | Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -3.47 units on a scale | Standard Deviation 5.17 |
| Tanezumab 20 mg | Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -2.39 units on a scale | Standard Deviation 4.61 |
| Tanezumab 20 mg | Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -3.35 units on a scale | Standard Deviation 4.87 |
| Tanezumab 20 mg | Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -2.82 units on a scale | Standard Deviation 4.65 |
| Tanezumab 20 mg | Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -3.26 units on a scale | Standard Deviation 4.81 |
| Tanezumab 20 mg | Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Baseline | 13.00 units on a scale | Standard Deviation 4.97 |
| Naproxen 500 mg | Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -2.44 units on a scale | Standard Deviation 4.12 |
| Naproxen 500 mg | Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -2.39 units on a scale | Standard Deviation 4.24 |
| Naproxen 500 mg | Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -2.28 units on a scale | Standard Deviation 4.19 |
| Naproxen 500 mg | Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -2.08 units on a scale | Standard Deviation 3.85 |
| Naproxen 500 mg | Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -2.27 units on a scale | Standard Deviation 4.12 |
| Naproxen 500 mg | Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Baseline | 12.86 units on a scale | Standard Deviation 4.93 |
Secondary
Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16
WPAI:SHP is a self-administered questionnaire that measures the effect of general health and symptom severity on work productivity and regular activities. Four scores are derived as percent: activity impairment (AI), impairment while working (IW), overall work impairment (OWI), work time missed (WTM). Each of 4 scores expressed as impairment percentages with a total possible score range of 0 to 100, high percentage= more impairment, less productivity.
Time frame: Baseline, Week 8, 16
Population: ITT analysis set. 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 for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Change at Week 16:Work Time Missed | -0.79 percentage of impairment | Standard Deviation 6.67 |
| Placebo | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Change at Week 16: Activity Impairment | -22.50 percentage of impairment | Standard Deviation 24.11 |
| Placebo | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Change at Week 8: Impairment While Working | -14.79 percentage of impairment | Standard Deviation 24.79 |
| Placebo | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Baseline: Impairment While Working | 49.19 percentage of impairment | Standard Deviation 24.85 |
| Placebo | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Change at Week 8: Work Time Missed | 0.58 percentage of impairment | Standard Deviation 8.78 |
| Placebo | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Change at Week 8: Overall Work Impairment | 0.43 percentage of impairment | Standard Deviation 21.56 |
| Placebo | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Baseline: Overall Work Impairment | 6.29 percentage of impairment | Standard Deviation 21.06 |
| Placebo | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Baseline: Activity Impairment | 58.77 percentage of impairment | Standard Deviation 22.88 |
| Placebo | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Change at Week 16:Overall Work Impairment | -2.52 percentage of impairment | Standard Deviation 14.15 |
| Placebo | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Baseline: Work Time Missed | 1.97 percentage of impairment | Standard Deviation 8.69 |
| Placebo | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Change at Week 16: Impairment While Working | -20.60 percentage of impairment | Standard Deviation 22.56 |
| Placebo | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Change at Week 8: Activity Impairment | -14.58 percentage of impairment | Standard Deviation 24.31 |
| Tanezumab 5 mg | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Baseline: Work Time Missed | 3.17 percentage of impairment | Standard Deviation 12.03 |
| Tanezumab 5 mg | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Baseline: Overall Work Impairment | 6.68 percentage of impairment | Standard Deviation 21.61 |
| Tanezumab 5 mg | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Change at Week 8: Work Time Missed | 0.16 percentage of impairment | Standard Deviation 9.53 |
| Tanezumab 5 mg | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Change at Week 16:Work Time Missed | -0.09 percentage of impairment | Standard Deviation 7.49 |
| Tanezumab 5 mg | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Change at Week 8: Impairment While Working | -10.75 percentage of impairment | Standard Deviation 25.42 |
| Tanezumab 5 mg | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Change at Week 8: Activity Impairment | -15.80 percentage of impairment | Standard Deviation 25.16 |
| Tanezumab 5 mg | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Change at Week 16: Impairment While Working | -15.22 percentage of impairment | Standard Deviation 24.05 |
| Tanezumab 5 mg | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Change at Week 16: Activity Impairment | -19.45 percentage of impairment | Standard Deviation 25.51 |
| Tanezumab 5 mg | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Baseline: Impairment While Working | 45.17 percentage of impairment | Standard Deviation 23.51 |
| Tanezumab 5 mg | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Baseline: Activity Impairment | 55.15 percentage of impairment | Standard Deviation 22.63 |
| Tanezumab 5 mg | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Change at Week 8: Overall Work Impairment | 0.08 percentage of impairment | Standard Deviation 19.74 |
| Tanezumab 5 mg | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Change at Week 16:Overall Work Impairment | -1.72 percentage of impairment | Standard Deviation 15.37 |
| Tanezumab 10 mg | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Change at Week 16:Overall Work Impairment | -3.92 percentage of impairment | Standard Deviation 24.38 |
| Tanezumab 10 mg | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Change at Week 8: Overall Work Impairment | -3.83 percentage of impairment | Standard Deviation 22.24 |
| Tanezumab 10 mg | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Baseline: Activity Impairment | 59.32 percentage of impairment | Standard Deviation 21.48 |
| Tanezumab 10 mg | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Baseline: Impairment While Working | 49.15 percentage of impairment | Standard Deviation 22.11 |
| Tanezumab 10 mg | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Baseline: Overall Work Impairment | 7.51 percentage of impairment | Standard Deviation 21.18 |
| Tanezumab 10 mg | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Baseline: Work Time Missed | 2.02 percentage of impairment | Standard Deviation 7.22 |
| Tanezumab 10 mg | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Change at Week 8: Activity Impairment | -24.96 percentage of impairment | Standard Deviation 26.32 |
| Tanezumab 10 mg | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Change at Week 8: Impairment While Working | -21.98 percentage of impairment | Standard Deviation 25.54 |
| Tanezumab 10 mg | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Change at Week 8: Work Time Missed | -0.38 percentage of impairment | Standard Deviation 9.12 |
| Tanezumab 10 mg | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Change at Week 16: Activity Impairment | -29.95 percentage of impairment | Standard Deviation 27.08 |
| Tanezumab 10 mg | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Change at Week 16: Impairment While Working | -27.65 percentage of impairment | Standard Deviation 26.17 |
| Tanezumab 10 mg | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Change at Week 16:Work Time Missed | -0.24 percentage of impairment | Standard Deviation 11.2 |
| Tanezumab 20 mg | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Change at Week 8: Impairment While Working | -19.21 percentage of impairment | Standard Deviation 45.39 |
| Tanezumab 20 mg | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Baseline: Activity Impairment | 60.81 percentage of impairment | Standard Deviation 20.74 |
| Tanezumab 20 mg | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Change at Week 8: Work Time Missed | -2.15 percentage of impairment | Standard Deviation 12.35 |
| Tanezumab 20 mg | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Change at Week 8: Activity Impairment | -27.08 percentage of impairment | Standard Deviation 28.65 |
| Tanezumab 20 mg | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Change at Week 16: Activity Impairment | -31.79 percentage of impairment | Standard Deviation 25.78 |
| Tanezumab 20 mg | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Baseline: Work Time Missed | 3.82 percentage of impairment | Standard Deviation 11.5 |
| Tanezumab 20 mg | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Change at Week 16:Work Time Missed | -2.98 percentage of impairment | Standard Deviation 10.69 |
| Tanezumab 20 mg | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Change at Week 16: Impairment While Working | -24.57 percentage of impairment | Standard Deviation 26.34 |
| Tanezumab 20 mg | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Baseline: Overall Work Impairment | 10.71 percentage of impairment | Standard Deviation 26.29 |
| Tanezumab 20 mg | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Baseline: Impairment While Working | 49.62 percentage of impairment | Standard Deviation 26.01 |
| Tanezumab 20 mg | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Change at Week 16:Overall Work Impairment | -7.71 percentage of impairment | Standard Deviation 24.1 |
| Tanezumab 20 mg | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Change at Week 8: Overall Work Impairment | -6.64 percentage of impairment | Standard Deviation 24.52 |
| Naproxen 500 mg | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Baseline: Activity Impairment | 59.97 percentage of impairment | Standard Deviation 21.27 |
| Naproxen 500 mg | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Change at Week 16: Impairment While Working | -21.05 percentage of impairment | Standard Deviation 24.54 |
| Naproxen 500 mg | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Change at Week 8: Impairment While Working | -16.70 percentage of impairment | Standard Deviation 23.23 |
| Naproxen 500 mg | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Change at Week 8: Work Time Missed | -1.74 percentage of impairment | Standard Deviation 9.25 |
| Naproxen 500 mg | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Baseline: Impairment While Working | 48.90 percentage of impairment | Standard Deviation 24.16 |
| Naproxen 500 mg | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Baseline: Work Time Missed | 3.26 percentage of impairment | Standard Deviation 11.79 |
| Naproxen 500 mg | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Change at Week 16:Work Time Missed | -2.30 percentage of impairment | Standard Deviation 11.6 |
| Naproxen 500 mg | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Change at Week 8: Activity Impairment | -18.53 percentage of impairment | Standard Deviation 24.08 |
| Naproxen 500 mg | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Change at Week 16: Activity Impairment | -24.28 percentage of impairment | Standard Deviation 24.62 |
| Naproxen 500 mg | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Change at Week 8: Overall Work Impairment | -4.58 percentage of impairment | Standard Deviation 20.24 |
| Naproxen 500 mg | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Baseline: Overall Work Impairment | 8.30 percentage of impairment | Standard Deviation 23.43 |
| Naproxen 500 mg | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Change at Week 16:Overall Work Impairment | -6.68 percentage of impairment | Standard Deviation 22.62 |
Secondary
Change From Baseline Neuropathy Impairment Score (NIS) at Week 8, 16 and 24
NIS is a standardized instrument used to evaluate signs of peripheral neuropathy in participants. NIS is the sum of scores of 37 items, from both the left and right side of following 4 domains: cranial nerves (5 items), muscle weakness (19 items), reflexes (5 items) and sensation (8 items). Each of 24 items related to cranial nerves and muscle weakness, scored from 0 (normal) to 4 (paralysis); higher scores indicated higher abnormality/impairment. Each of 13 items related to reflexes and sensation, scored as 0 (normal), 1 (decreased) and 2 (absent); higher scores indicated lesser reflexes and sensation. For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits.
Time frame: Baseline, Week 8, 16, 24
Population: ITT analysis set included all participants who received at least 1 dose of intravenous study medication. Here 'Number Analyzed' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline Neuropathy Impairment Score (NIS) at Week 8, 16 and 24 | Baseline | 0.97 units on a scale | Standard Deviation 2.68 |
| Placebo | Change From Baseline Neuropathy Impairment Score (NIS) at Week 8, 16 and 24 | Change at Week 8 | -0.15 units on a scale | Standard Deviation 1.43 |
| Placebo | Change From Baseline Neuropathy Impairment Score (NIS) at Week 8, 16 and 24 | Change at Week 16 | -0.30 units on a scale | Standard Deviation 1.67 |
| Placebo | Change From Baseline Neuropathy Impairment Score (NIS) at Week 8, 16 and 24 | Change at Week 24 | -0.74 units on a scale | Standard Deviation 3.47 |
| Tanezumab 5 mg | Change From Baseline Neuropathy Impairment Score (NIS) at Week 8, 16 and 24 | Baseline | 1.16 units on a scale | Standard Deviation 3.04 |
| Tanezumab 5 mg | Change From Baseline Neuropathy Impairment Score (NIS) at Week 8, 16 and 24 | Change at Week 24 | -0.15 units on a scale | Standard Deviation 1.09 |
| Tanezumab 5 mg | Change From Baseline Neuropathy Impairment Score (NIS) at Week 8, 16 and 24 | Change at Week 8 | -0.41 units on a scale | Standard Deviation 2.79 |
| Tanezumab 5 mg | Change From Baseline Neuropathy Impairment Score (NIS) at Week 8, 16 and 24 | Change at Week 16 | -0.27 units on a scale | Standard Deviation 1.96 |
| Tanezumab 10 mg | Change From Baseline Neuropathy Impairment Score (NIS) at Week 8, 16 and 24 | Change at Week 24 | 0.10 units on a scale | Standard Deviation 1.04 |
| Tanezumab 10 mg | Change From Baseline Neuropathy Impairment Score (NIS) at Week 8, 16 and 24 | Change at Week 8 | -0.09 units on a scale | Standard Deviation 1.49 |
| Tanezumab 10 mg | Change From Baseline Neuropathy Impairment Score (NIS) at Week 8, 16 and 24 | Change at Week 16 | 0.05 units on a scale | Standard Deviation 1.36 |
| Tanezumab 10 mg | Change From Baseline Neuropathy Impairment Score (NIS) at Week 8, 16 and 24 | Baseline | 1.03 units on a scale | Standard Deviation 2.79 |
| Tanezumab 20 mg | Change From Baseline Neuropathy Impairment Score (NIS) at Week 8, 16 and 24 | Baseline | 1.31 units on a scale | Standard Deviation 4.75 |
| Tanezumab 20 mg | Change From Baseline Neuropathy Impairment Score (NIS) at Week 8, 16 and 24 | Change at Week 8 | -0.38 units on a scale | Standard Deviation 3.61 |
| Tanezumab 20 mg | Change From Baseline Neuropathy Impairment Score (NIS) at Week 8, 16 and 24 | Change at Week 24 | -0.46 units on a scale | Standard Deviation 1.22 |
| Tanezumab 20 mg | Change From Baseline Neuropathy Impairment Score (NIS) at Week 8, 16 and 24 | Change at Week 16 | 0.02 units on a scale | Standard Deviation 1.63 |
| Naproxen 500 mg | Change From Baseline Neuropathy Impairment Score (NIS) at Week 8, 16 and 24 | Change at Week 24 | -0.48 units on a scale | Standard Deviation 1.48 |
| Naproxen 500 mg | Change From Baseline Neuropathy Impairment Score (NIS) at Week 8, 16 and 24 | Change at Week 16 | -0.18 units on a scale | Standard Deviation 1.43 |
| Naproxen 500 mg | Change From Baseline Neuropathy Impairment Score (NIS) at Week 8, 16 and 24 | Change at Week 8 | -0.06 units on a scale | Standard Deviation 1.14 |
| Naproxen 500 mg | Change From Baseline Neuropathy Impairment Score (NIS) at Week 8, 16 and 24 | Baseline | 1.02 units on a scale | Standard Deviation 2.82 |
Secondary
Duration of Rescue Medication Use
In case of inadequate pain relief for CLBP or for non-CLBP related pain, acetaminophen up to 3000 mg per day up to 3 days per week could be taken as rescue medication.
Time frame: Week 2, 4, 8, 12, 16
Population: ITT analysis set. LOCF method was used to impute missing values. 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 outcome measure at given time points for each group, respectively.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Duration of Rescue Medication Use | Week 8 | 1.0 days/week |
| Placebo | Duration of Rescue Medication Use | Week 16 | 0.0 days/week |
| Placebo | Duration of Rescue Medication Use | Week 2 | 2.0 days/week |
| Placebo | Duration of Rescue Medication Use | Week 12 | 0.0 days/week |
| Placebo | Duration of Rescue Medication Use | Week 4 | 2.0 days/week |
| Tanezumab 5 mg | Duration of Rescue Medication Use | Week 2 | 2.0 days/week |
| Tanezumab 5 mg | Duration of Rescue Medication Use | Week 16 | 0.0 days/week |
| Tanezumab 5 mg | Duration of Rescue Medication Use | Week 4 | 1.0 days/week |
| Tanezumab 5 mg | Duration of Rescue Medication Use | Week 8 | 0.0 days/week |
| Tanezumab 5 mg | Duration of Rescue Medication Use | Week 12 | 0.0 days/week |
| Tanezumab 10 mg | Duration of Rescue Medication Use | Week 8 | 1.0 days/week |
| Tanezumab 10 mg | Duration of Rescue Medication Use | Week 2 | 2.0 days/week |
| Tanezumab 10 mg | Duration of Rescue Medication Use | Week 4 | 1.0 days/week |
| Tanezumab 10 mg | Duration of Rescue Medication Use | Week 12 | 0.0 days/week |
| Tanezumab 10 mg | Duration of Rescue Medication Use | Week 16 | 0.0 days/week |
| Tanezumab 20 mg | Duration of Rescue Medication Use | Week 16 | 0.0 days/week |
| Tanezumab 20 mg | Duration of Rescue Medication Use | Week 4 | 1.0 days/week |
| Tanezumab 20 mg | Duration of Rescue Medication Use | Week 12 | 0.0 days/week |
| Tanezumab 20 mg | Duration of Rescue Medication Use | Week 8 | 0.0 days/week |
| Tanezumab 20 mg | Duration of Rescue Medication Use | Week 2 | 2.0 days/week |
| Naproxen 500 mg | Duration of Rescue Medication Use | Week 8 | 0.0 days/week |
| Naproxen 500 mg | Duration of Rescue Medication Use | Week 12 | 0.0 days/week |
| Naproxen 500 mg | Duration of Rescue Medication Use | Week 4 | 1.0 days/week |
| Naproxen 500 mg | Duration of Rescue Medication Use | Week 16 | 0.0 days/week |
| Naproxen 500 mg | Duration of Rescue Medication Use | Week 2 | 1.0 days/week |
Secondary
Number of Participants Who Developed Anti-Tanezumab Antibodies
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). Same participant may have positive ADA result at more than 1 time point.
Time frame: Baseline (Day 1), Week 8, 16, 24
Population: ITT analysis set included all participants who received at least 1 dose of intravenous study medication. Here, Overall number of participants analyzed = participants who were evaluable for this outcome measure and 'Number Analyzed' = participants who were evaluable for this outcome measure at given time points for each group, respectively
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants Who Developed Anti-Tanezumab Antibodies | Baseline | 0 Participants |
| Placebo | Number of Participants Who Developed Anti-Tanezumab Antibodies | Week 8 | 0 Participants |
| Placebo | Number of Participants Who Developed Anti-Tanezumab Antibodies | Week 16 | 0 Participants |
| Placebo | Number of Participants Who Developed Anti-Tanezumab Antibodies | Week 24 | 0 Participants |
| Tanezumab 5 mg | Number of Participants Who Developed Anti-Tanezumab Antibodies | Week 24 | 1 Participants |
| Tanezumab 5 mg | Number of Participants Who Developed Anti-Tanezumab Antibodies | Baseline | 1 Participants |
| Tanezumab 5 mg | Number of Participants Who Developed Anti-Tanezumab Antibodies | Week 16 | 1 Participants |
| Tanezumab 5 mg | Number of Participants Who Developed Anti-Tanezumab Antibodies | Week 8 | 0 Participants |
| Tanezumab 10 mg | Number of Participants Who Developed Anti-Tanezumab Antibodies | Week 24 | 1 Participants |
| Tanezumab 10 mg | Number of Participants Who Developed Anti-Tanezumab Antibodies | Week 8 | 0 Participants |
| Tanezumab 10 mg | Number of Participants Who Developed Anti-Tanezumab Antibodies | Week 16 | 1 Participants |
| Tanezumab 10 mg | Number of Participants Who Developed Anti-Tanezumab Antibodies | Baseline | 0 Participants |
Secondary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
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 Week 24 that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial.
Time frame: Baseline up to Week 24
Population: ITT analysis set included all participants who received at least 1 dose of intravenous study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 5 Participants |
| Placebo | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 120 Participants |
| Tanezumab 5 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 4 Participants |
| Tanezumab 5 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 141 Participants |
| Tanezumab 10 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 171 Participants |
| Tanezumab 10 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 3 Participants |
| Tanezumab 20 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 190 Participants |
| Tanezumab 20 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 3 Participants |
| Naproxen 500 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 5 Participants |
| Naproxen 500 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 142 Participants |
Secondary
Number of Participants With Chronic Low Back Pain (CLBP) Responder Index: Baseline Observation Carried Forward (BOCF)
Chronic Low Back Pain (CLBP) Responder Index: A response was defined as reduction of at least 30% in mean daily average LBPI from baseline to a specified week, decrease of at least 30% in PGA of low back pain from baseline to the specified week and no worsening (increase) in RMDQ total score from baseline to the specified week. Participants who were responders were reported.
Time frame: Week 2, 4, 8, 12, 16
Population: ITT analysis set included all participants who received at least 1 dose of intravenous study medication. BOCF method was used to impute missing values.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Chronic Low Back Pain (CLBP) Responder Index: Baseline Observation Carried Forward (BOCF) | Week 2 | 38 participants |
| Placebo | Number of Participants With Chronic Low Back Pain (CLBP) Responder Index: Baseline Observation Carried Forward (BOCF) | Week 4 | 52 participants |
| Placebo | Number of Participants With Chronic Low Back Pain (CLBP) Responder Index: Baseline Observation Carried Forward (BOCF) | Week 8 | 40 participants |
| Placebo | Number of Participants With Chronic Low Back Pain (CLBP) Responder Index: Baseline Observation Carried Forward (BOCF) | Week 12 | 45 participants |
| Placebo | Number of Participants With Chronic Low Back Pain (CLBP) Responder Index: Baseline Observation Carried Forward (BOCF) | Week 16 | 44 participants |
| Tanezumab 5 mg | Number of Participants With Chronic Low Back Pain (CLBP) Responder Index: Baseline Observation Carried Forward (BOCF) | Week 16 | 52 participants |
| Tanezumab 5 mg | Number of Participants With Chronic Low Back Pain (CLBP) Responder Index: Baseline Observation Carried Forward (BOCF) | Week 12 | 60 participants |
| Tanezumab 5 mg | Number of Participants With Chronic Low Back Pain (CLBP) Responder Index: Baseline Observation Carried Forward (BOCF) | Week 4 | 70 participants |
| Tanezumab 5 mg | Number of Participants With Chronic Low Back Pain (CLBP) Responder Index: Baseline Observation Carried Forward (BOCF) | Week 2 | 48 participants |
| Tanezumab 5 mg | Number of Participants With Chronic Low Back Pain (CLBP) Responder Index: Baseline Observation Carried Forward (BOCF) | Week 8 | 62 participants |
| Tanezumab 10 mg | Number of Participants With Chronic Low Back Pain (CLBP) Responder Index: Baseline Observation Carried Forward (BOCF) | Week 2 | 77 participants |
| Tanezumab 10 mg | Number of Participants With Chronic Low Back Pain (CLBP) Responder Index: Baseline Observation Carried Forward (BOCF) | Week 8 | 96 participants |
| Tanezumab 10 mg | Number of Participants With Chronic Low Back Pain (CLBP) Responder Index: Baseline Observation Carried Forward (BOCF) | Week 12 | 104 participants |
| Tanezumab 10 mg | Number of Participants With Chronic Low Back Pain (CLBP) Responder Index: Baseline Observation Carried Forward (BOCF) | Week 16 | 90 participants |
| Tanezumab 10 mg | Number of Participants With Chronic Low Back Pain (CLBP) Responder Index: Baseline Observation Carried Forward (BOCF) | Week 4 | 114 participants |
| Tanezumab 20 mg | Number of Participants With Chronic Low Back Pain (CLBP) Responder Index: Baseline Observation Carried Forward (BOCF) | Week 16 | 89 participants |
| Tanezumab 20 mg | Number of Participants With Chronic Low Back Pain (CLBP) Responder Index: Baseline Observation Carried Forward (BOCF) | Week 4 | 113 participants |
| Tanezumab 20 mg | Number of Participants With Chronic Low Back Pain (CLBP) Responder Index: Baseline Observation Carried Forward (BOCF) | Week 2 | 80 participants |
| Tanezumab 20 mg | Number of Participants With Chronic Low Back Pain (CLBP) Responder Index: Baseline Observation Carried Forward (BOCF) | Week 12 | 105 participants |
| Tanezumab 20 mg | Number of Participants With Chronic Low Back Pain (CLBP) Responder Index: Baseline Observation Carried Forward (BOCF) | Week 8 | 103 participants |
| Naproxen 500 mg | Number of Participants With Chronic Low Back Pain (CLBP) Responder Index: Baseline Observation Carried Forward (BOCF) | Week 16 | 63 participants |
| Naproxen 500 mg | Number of Participants With Chronic Low Back Pain (CLBP) Responder Index: Baseline Observation Carried Forward (BOCF) | Week 2 | 69 participants |
| Naproxen 500 mg | Number of Participants With Chronic Low Back Pain (CLBP) Responder Index: Baseline Observation Carried Forward (BOCF) | Week 8 | 64 participants |
| Naproxen 500 mg | Number of Participants With Chronic Low Back Pain (CLBP) Responder Index: Baseline Observation Carried Forward (BOCF) | Week 4 | 79 participants |
| Naproxen 500 mg | Number of Participants With Chronic Low Back Pain (CLBP) Responder Index: Baseline Observation Carried Forward (BOCF) | Week 12 | 83 participants |
Secondary
Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF)
Daily average back pain was assessed on an 11-point numeric rating scale (NRS) captured through an interactive voice response system (IVRS). The participant described the chronic low back pain (CLBP) 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 days prior to randomization (initial pain assessment period). Post-baseline value was calculated as mean of the scores over the 7-day period prior to and including the post-baseline visit. Participants with specified reduction (as percent) from baseline at Week 16 are reported.
Time frame: Baseline, Week 16
Population: ITT analysis set included all participants who received at least 1 dose of intravenous study medication. BOCF method was used to impute missing values.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | >= 50% | 39 Participants |
| Placebo | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | >= 60% | 31 Participants |
| Placebo | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | Greater than (>) 0% | 103 Participants |
| Placebo | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | >= 80% | 12 Participants |
| Placebo | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | >= 30% | 62 Participants |
| Placebo | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | >= 90% | 8 Participants |
| Placebo | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | = 100% | 5 Participants |
| Placebo | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | >= 20% | 78 Participants |
| Placebo | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | >= 70% | 22 Participants |
| Placebo | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | >= 40% | 53 Participants |
| Placebo | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | Greater than or equal to (>=)10% | 90 Participants |
| Tanezumab 5 mg | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | >= 40% | 64 Participants |
| Tanezumab 5 mg | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | >= 60% | 42 Participants |
| Tanezumab 5 mg | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | >= 50% | 59 Participants |
| Tanezumab 5 mg | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | Greater than or equal to (>=)10% | 111 Participants |
| Tanezumab 5 mg | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | Greater than (>) 0% | 121 Participants |
| Tanezumab 5 mg | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | >= 90% | 12 Participants |
| Tanezumab 5 mg | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | >= 20% | 99 Participants |
| Tanezumab 5 mg | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | = 100% | 9 Participants |
| Tanezumab 5 mg | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | >= 80% | 24 Participants |
| Tanezumab 5 mg | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | >= 30% | 83 Participants |
| Tanezumab 5 mg | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | >= 70% | 29 Participants |
| Tanezumab 10 mg | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | >= 50% | 94 Participants |
| Tanezumab 10 mg | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | Greater than (>) 0% | 171 Participants |
| Tanezumab 10 mg | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | Greater than or equal to (>=)10% | 159 Participants |
| Tanezumab 10 mg | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | >= 20% | 136 Participants |
| Tanezumab 10 mg | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | >= 30% | 123 Participants |
| Tanezumab 10 mg | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | >= 40% | 112 Participants |
| Tanezumab 10 mg | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | >= 60% | 78 Participants |
| Tanezumab 10 mg | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | >= 70% | 62 Participants |
| Tanezumab 10 mg | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | >= 80% | 45 Participants |
| Tanezumab 10 mg | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | >= 90% | 30 Participants |
| Tanezumab 10 mg | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | = 100% | 20 Participants |
| Tanezumab 20 mg | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | >= 30% | 137 Participants |
| Tanezumab 20 mg | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | Greater than (>) 0% | 174 Participants |
| Tanezumab 20 mg | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | Greater than or equal to (>=)10% | 162 Participants |
| Tanezumab 20 mg | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | = 100% | 16 Participants |
| Tanezumab 20 mg | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | >= 90% | 26 Participants |
| Tanezumab 20 mg | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | >= 20% | 145 Participants |
| Tanezumab 20 mg | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | >= 50% | 104 Participants |
| Tanezumab 20 mg | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | >= 70% | 54 Participants |
| Tanezumab 20 mg | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | >= 80% | 40 Participants |
| Tanezumab 20 mg | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | >= 40% | 120 Participants |
| Tanezumab 20 mg | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | >= 60% | 80 Participants |
| Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | Greater than (>) 0% | 160 Participants |
| Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | >= 60% | 60 Participants |
| Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | >= 30% | 111 Participants |
| Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | >= 70% | 37 Participants |
| Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | >= 20% | 128 Participants |
| Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | = 100% | 9 Participants |
| Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | >= 80% | 26 Participants |
| Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | Greater than or equal to (>=)10% | 146 Participants |
| Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | >= 90% | 16 Participants |
| Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | >= 50% | 78 Participants |
| Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | >= 40% | 92 Participants |
Secondary
Percentage of Participants Who Used Rescue Medications
In case of inadequate pain relief for CLBP or for non-CLBP related pain, acetaminophen up to 3000 mg per day up to 3 days per week could be taken as rescue medication.
Time frame: Week 2, 4, 8, 12, 16
Population: ITT analysis set. LOCF method was used to impute missing values. 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 outcome measure at given time points for each group, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Who Used Rescue Medications | Week 12 | 40.4 percentage of participants |
| Placebo | Percentage of Participants Who Used Rescue Medications | Week 2 | 70.3 percentage of participants |
| Placebo | Percentage of Participants Who Used Rescue Medications | Week 4 | 63.9 percentage of participants |
| Placebo | Percentage of Participants Who Used Rescue Medications | Week 8 | 54.8 percentage of participants |
| Placebo | Percentage of Participants Who Used Rescue Medications | Week 16 | 42.6 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Who Used Rescue Medications | Week 2 | 69.7 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Who Used Rescue Medications | Week 16 | 41.4 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Who Used Rescue Medications | Week 4 | 53.9 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Who Used Rescue Medications | Week 12 | 40.5 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Who Used Rescue Medications | Week 8 | 49.6 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants Who Used Rescue Medications | Week 12 | 45.1 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants Who Used Rescue Medications | Week 2 | 74.1 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants Who Used Rescue Medications | Week 16 | 43.0 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants Who Used Rescue Medications | Week 4 | 54.3 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants Who Used Rescue Medications | Week 8 | 50.9 percentage of participants |
| Tanezumab 20 mg | Percentage of Participants Who Used Rescue Medications | Week 4 | 53.4 percentage of participants |
| Tanezumab 20 mg | Percentage of Participants Who Used Rescue Medications | Week 2 | 73.4 percentage of participants |
| Tanezumab 20 mg | Percentage of Participants Who Used Rescue Medications | Week 8 | 47.6 percentage of participants |
| Tanezumab 20 mg | Percentage of Participants Who Used Rescue Medications | Week 12 | 38.7 percentage of participants |
| Tanezumab 20 mg | Percentage of Participants Who Used Rescue Medications | Week 16 | 38.0 percentage of participants |
| Naproxen 500 mg | Percentage of Participants Who Used Rescue Medications | Week 8 | 48.3 percentage of participants |
| Naproxen 500 mg | Percentage of Participants Who Used Rescue Medications | Week 2 | 60.8 percentage of participants |
| Naproxen 500 mg | Percentage of Participants Who Used Rescue Medications | Week 4 | 53.2 percentage of participants |
| Naproxen 500 mg | Percentage of Participants Who Used Rescue Medications | Week 16 | 41.2 percentage of participants |
| Naproxen 500 mg | Percentage of Participants Who Used Rescue Medications | Week 12 | 44.6 percentage of participants |
Secondary
Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
Daily average back pain was assessed on an 11-point numeric rating scale (NRS) captured through an interactive voice response system (IVRS). The participant described the chronic low back pain (CLBP) 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 days prior to randomization (initial pain assessment period). Post-baseline value was calculated as mean of the scores over the 7-day period prior to and including the post-baseline visit.
Time frame: Baseline, Week 2, 4, 8, 12, 16
Population: ITT analysis set included all participants who received at least 1 dose of intravenous study medication. BOCF method was used to impute missing values.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Week 12: >=30% reduction | 31.3 percentage of participants |
| Placebo | Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Week 8: >=30% reduction | 32.2 percentage of participants |
| Placebo | Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Week 16: >=50% reduction | 17.0 percentage of participants |
| Placebo | Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Week 8: >=50% reduction | 18.7 percentage of participants |
| Placebo | Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Week 2: >=50% reduction | 11.3 percentage of participants |
| Placebo | Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Week 16: >=30% reduction | 27.0 percentage of participants |
| Placebo | Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Week 4: >=30% reduction | 33.9 percentage of participants |
| Placebo | Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Week 2: >=30% reduction | 27.4 percentage of participants |
| Placebo | Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Week 12: >=50% reduction | 22.2 percentage of participants |
| Placebo | Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Week 4: >=50% reduction | 16.5 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Week 16: >=50% reduction | 25.4 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Week 12: >=30% reduction | 42.7 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Week 8: >=30% reduction | 43.1 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Week 4: >=30% reduction | 43.5 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Week 8: >=50% reduction | 25.4 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Week 4: >=50% reduction | 28.9 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Week 12: >=50% reduction | 31.0 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Week 2: >=50% reduction | 20.7 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Week 2: >=30% reduction | 32.8 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Week 16: >=30% reduction | 35.8 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Week 16: >=30% reduction | 41.7 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Week 2: >=30% reduction | 42.4 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Week 2: >=50% reduction | 19.3 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Week 4: >=30% reduction | 54.2 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Week 4: >=50% reduction | 35.6 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Week 8: >=30% reduction | 48.1 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Week 8: >=50% reduction | 32.5 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Week 12: >=30% reduction | 48.1 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Week 12: >=50% reduction | 36.3 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Week 16: >=50% reduction | 31.9 percentage of participants |
| Tanezumab 20 mg | Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Week 12: >=30% reduction | 50.5 percentage of participants |
| Tanezumab 20 mg | Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Week 4: >=50% reduction | 35.9 percentage of participants |
| Tanezumab 20 mg | Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Week 2: >=50% reduction | 22.0 percentage of participants |
| Tanezumab 20 mg | Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Week 2: >=30% reduction | 41.0 percentage of participants |
| Tanezumab 20 mg | Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Week 16: >=30% reduction | 46.4 percentage of participants |
| Tanezumab 20 mg | Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Week 4: >=30% reduction | 52.5 percentage of participants |
| Tanezumab 20 mg | Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Week 16: >=50% reduction | 35.3 percentage of participants |
| Tanezumab 20 mg | Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Week 8: >=30% reduction | 50.8 percentage of participants |
| Tanezumab 20 mg | Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Week 12: >=50% reduction | 40.0 percentage of participants |
| Tanezumab 20 mg | Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Week 8: >=50% reduction | 35.3 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Week 12: >=50% reduction | 30.8 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Week 4: >=50% reduction | 25.8 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Week 12: >=30% reduction | 42.7 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Week 4: >=30% reduction | 42.0 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Week 8: >=50% reduction | 22.7 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Week 2: >=50% reduction | 24.4 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Week 16: >=50% reduction | 26.4 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Week 16: >=30% reduction | 37.6 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Week 8: >=30% reduction | 39.7 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Week 2: >=30% reduction | 39.0 percentage of participants |
Secondary
Plasma Concentration of Tanezumab
Analysis was done by setting concentration values below the lower limit of quantification (LLOQ) to zero.
Time frame: Baseline (pre-dose and 1 hour [hr] post-dose); Any time point at Week 4 Visit; Week 8 (pre-dose and 1 hr post-dose); Any time point at Week 16 Visit, at Week 24 Visit
Population: ITT analysis set included all participants who received at least 1 dose of intravenous study medication. Here, Overall number of participants analyzed = participants who were evaluable for this outcome measure and 'Number Analyzed' = participants who were evaluable for this outcome measure at given time points for each group, respectively
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Plasma Concentration of Tanezumab | Baseline: 1 hr post-dose | 1944.46 nanogram per milliliter | Standard Deviation 572.9289 |
| Placebo | Plasma Concentration of Tanezumab | Week 16 | 239.804 nanogram per milliliter | Standard Deviation 245.3006 |
| Placebo | Plasma Concentration of Tanezumab | Week 24 | 276.991 nanogram per milliliter | Standard Deviation 402.0603 |
| Placebo | Plasma Concentration of Tanezumab | Baseline: pre-dose | 70.7627 nanogram per milliliter | Standard Deviation 315.3581 |
| Placebo | Plasma Concentration of Tanezumab | Week 4 | 472.248 nanogram per milliliter | Standard Deviation 238.5394 |
| Placebo | Plasma Concentration of Tanezumab | Week 8: pre-dose | 240.405 nanogram per milliliter | Standard Deviation 333.299 |
| Placebo | Plasma Concentration of Tanezumab | Week 8: 1 hr post-dose | 2026.01 nanogram per milliliter | Standard Deviation 693.579 |
| Tanezumab 5 mg | Plasma Concentration of Tanezumab | Baseline: 1 hr post-dose | 4105.46 nanogram per milliliter | Standard Deviation 1495.906 |
| Tanezumab 5 mg | Plasma Concentration of Tanezumab | Week 8: pre-dose | 442.843 nanogram per milliliter | Standard Deviation 208.619 |
| Tanezumab 5 mg | Plasma Concentration of Tanezumab | Week 16 | 531.014 nanogram per milliliter | Standard Deviation 256.1994 |
| Tanezumab 5 mg | Plasma Concentration of Tanezumab | Week 8: 1 hr post-dose | 4637.82 nanogram per milliliter | Standard Deviation 2630.921 |
| Tanezumab 5 mg | Plasma Concentration of Tanezumab | Week 4 | 983.377 nanogram per milliliter | Standard Deviation 346.1361 |
| Tanezumab 5 mg | Plasma Concentration of Tanezumab | Week 24 | 636.217 nanogram per milliliter | Standard Deviation 567.9855 |
| Tanezumab 5 mg | Plasma Concentration of Tanezumab | Baseline: pre-dose | 60.2354 nanogram per milliliter | Standard Deviation 383.8924 |
| Tanezumab 10 mg | Plasma Concentration of Tanezumab | Week 24 | 1222.17 nanogram per milliliter | Standard Deviation 1105.125 |
| Tanezumab 10 mg | Plasma Concentration of Tanezumab | Baseline: pre-dose | 40.9396 nanogram per milliliter | Standard Deviation 317.3858 |
| Tanezumab 10 mg | Plasma Concentration of Tanezumab | Baseline: 1 hr post-dose | 8460.14 nanogram per milliliter | Standard Deviation 2983.547 |
| Tanezumab 10 mg | Plasma Concentration of Tanezumab | Week 4 | 1983.72 nanogram per milliliter | Standard Deviation 598.786 |
| Tanezumab 10 mg | Plasma Concentration of Tanezumab | Week 8: pre-dose | 1081.69 nanogram per milliliter | Standard Deviation 997.0692 |
| Tanezumab 10 mg | Plasma Concentration of Tanezumab | Week 8: 1 hr post-dose | 9161.84 nanogram per milliliter | Standard Deviation 4274.392 |
| Tanezumab 10 mg | Plasma Concentration of Tanezumab | Week 16 | 1393.40 nanogram per milliliter | Standard Deviation 1219.27 |
Secondary
Time to Discontinuation Due to Lack of Efficacy
Median time to discontinuation due to lack of efficacy was estimated using Kaplan-Meier method.
Time frame: Baseline up to Week 16
Population: ITT analysis set included all participants who received at least 1 dose of intravenous study medication.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to Discontinuation Due to Lack of Efficacy | NA days |
| Tanezumab 5 mg | Time to Discontinuation Due to Lack of Efficacy | NA days |
| Tanezumab 10 mg | Time to Discontinuation Due to Lack of Efficacy | NA days |
| Tanezumab 20 mg | Time to Discontinuation Due to Lack of Efficacy | NA days |
| Naproxen 500 mg | Time to Discontinuation Due to Lack of Efficacy | NA days |
Secondary
Total Nerve Growth Factor (NGF) Concentration
Time frame: Baseline (pre-dose and 1 hour [hr] post-dose); Any time point at Week 4 Visit; Week 8 (pre-dose and 1 hr post-dose); Any time point at Week 16 Visit, at Week 24 Visit
Population: ITT analysis set included all participants who received at least 1 dose of intravenous study medication. Here, Overall number of participants analyzed = participants who were evaluable for this outcome measure and 'Number Analyzed' = participants who were evaluable for this outcome measure at given time points for each group, respectively
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Total Nerve Growth Factor (NGF) Concentration | Week 8: 1 hr post-dose | 124.71 picogram per mL | Standard Deviation 750.3 |
| Placebo | Total Nerve Growth Factor (NGF) Concentration | Week 8: pre-dose | 126.66 picogram per mL | Standard Deviation 707.6 |
| Placebo | Total Nerve Growth Factor (NGF) Concentration | Baseline: pre-dose | 34.65 picogram per mL | Standard Deviation 11.68 |
| Placebo | Total Nerve Growth Factor (NGF) Concentration | Week 24 | 226.61 picogram per mL | Standard Deviation 916.4 |
| Placebo | Total Nerve Growth Factor (NGF) Concentration | Baseline: 1 hr post-dose | 37.90 picogram per mL | Standard Deviation 11.99 |
| Placebo | Total Nerve Growth Factor (NGF) Concentration | Week 16 | 41.96 picogram per mL | Standard Deviation 23.56 |
| Placebo | Total Nerve Growth Factor (NGF) Concentration | Week 4 | 92.33 picogram per mL | Standard Deviation 655.1 |
| Tanezumab 5 mg | Total Nerve Growth Factor (NGF) Concentration | Week 4 | 3217.6 picogram per mL | Standard Deviation 1134 |
| Tanezumab 5 mg | Total Nerve Growth Factor (NGF) Concentration | Baseline: 1 hr post-dose | 96.76 picogram per mL | Standard Deviation 35.08 |
| Tanezumab 5 mg | Total Nerve Growth Factor (NGF) Concentration | Week 8: pre-dose | 2671.7 picogram per mL | Standard Deviation 1249 |
| Tanezumab 5 mg | Total Nerve Growth Factor (NGF) Concentration | Week 24 | 2602.0 picogram per mL | Standard Deviation 1486 |
| Tanezumab 5 mg | Total Nerve Growth Factor (NGF) Concentration | Baseline: pre-dose | 44.38 picogram per mL | Standard Deviation 49.12 |
| Tanezumab 5 mg | Total Nerve Growth Factor (NGF) Concentration | Week 8: 1 hr post-dose | 2943.5 picogram per mL | Standard Deviation 1334 |
| Tanezumab 5 mg | Total Nerve Growth Factor (NGF) Concentration | Week 16 | 3263.0 picogram per mL | Standard Deviation 1539 |
| Tanezumab 10 mg | Total Nerve Growth Factor (NGF) Concentration | Baseline: pre-dose | 55.66 picogram per mL | Standard Deviation 202 |
| Tanezumab 10 mg | Total Nerve Growth Factor (NGF) Concentration | Baseline: 1 hr post-dose | 113.33 picogram per mL | Standard Deviation 251.5 |
| Tanezumab 10 mg | Total Nerve Growth Factor (NGF) Concentration | Week 4 | 3981.7 picogram per mL | Standard Deviation 1362 |
| Tanezumab 10 mg | Total Nerve Growth Factor (NGF) Concentration | Week 8: pre-dose | 3624.7 picogram per mL | Standard Deviation 1398 |
| Tanezumab 10 mg | Total Nerve Growth Factor (NGF) Concentration | Week 8: 1 hr post-dose | 3950.9 picogram per mL | Standard Deviation 1479 |
| Tanezumab 10 mg | Total Nerve Growth Factor (NGF) Concentration | Week 16 | 4490.5 picogram per mL | Standard Deviation 1953 |
| Tanezumab 10 mg | Total Nerve Growth Factor (NGF) Concentration | Week 24 | 3549.5 picogram per mL | Standard Deviation 1747 |
| Tanezumab 20 mg | Total Nerve Growth Factor (NGF) Concentration | Week 4 | 4456.7 picogram per mL | Standard Deviation 1325 |
| Tanezumab 20 mg | Total Nerve Growth Factor (NGF) Concentration | Week 8: 1 hr post-dose | 4929.1 picogram per mL | Standard Deviation 1775 |
| Tanezumab 20 mg | Total Nerve Growth Factor (NGF) Concentration | Week 24 | 4420.3 picogram per mL | Standard Deviation 1776 |
| Tanezumab 20 mg | Total Nerve Growth Factor (NGF) Concentration | Week 16 | 5842.2 picogram per mL | Standard Deviation 2377 |
| Tanezumab 20 mg | Total Nerve Growth Factor (NGF) Concentration | Baseline: pre-dose | 61.79 picogram per mL | Standard Deviation 220.7 |
| Tanezumab 20 mg | Total Nerve Growth Factor (NGF) Concentration | Baseline: 1 hr post-dose | 126.50 picogram per mL | Standard Deviation 192.8 |
| Tanezumab 20 mg | Total Nerve Growth Factor (NGF) Concentration | Week 8: pre-dose | 4238.6 picogram per mL | Standard Deviation 1604 |
| Naproxen 500 mg | Total Nerve Growth Factor (NGF) Concentration | Week 8: pre-dose | 41.47 picogram per mL | Standard Deviation 80.11 |
| Naproxen 500 mg | Total Nerve Growth Factor (NGF) Concentration | Week 24 | 38.77 picogram per mL | Standard Deviation 15.66 |
| Naproxen 500 mg | Total Nerve Growth Factor (NGF) Concentration | Week 16 | 135.17 picogram per mL | Standard Deviation 810.2 |
| Naproxen 500 mg | Total Nerve Growth Factor (NGF) Concentration | Week 8: 1 hr post-dose | 69.74 picogram per mL | Standard Deviation 241.8 |
| Naproxen 500 mg | Total Nerve Growth Factor (NGF) Concentration | Baseline: 1 hr post-dose | 40.30 picogram per mL | Standard Deviation 13.1 |
| Naproxen 500 mg | Total Nerve Growth Factor (NGF) Concentration | Baseline: pre-dose | 35.50 picogram per mL | Standard Deviation 12.38 |
| Naproxen 500 mg | Total Nerve Growth Factor (NGF) Concentration | Week 4 | 38.17 picogram per mL | Standard Deviation 16.11 |