Low Back Pain
Conditions
Brief summary
The primary objective of this study is to evaluate the analgesic efficacy of RN624 compared with placebo and compared with naproxen in the treatment of adult patients with chronic low back pain.
Interventions
DRUGNaproxen
Oral naproxen 500 mg twice daily for Weeks 1-12.
DRUGPlacebo
Single IV infusion of placebo on Day 1 and placebo for naproxen twice daily for Weeks 1-12.
DRUGPF-04383119 (RN624)
Single IV infusion of 200 micrograms/kg RN624 on Day 1
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Male or female of any race, \>18 years of age and have BMI ≤39 kg/m2 * Present with duration of chronic low back pain of ≥3 months requiring regular use of analgesic medication (\>4 days per week for the past month) * Primary location of low back pain is between the 12th thoracic vertebra and the lower gluteal folds, with or without radiation into the posterior thigh, classified as Category 1 or 2 according to the classification of the Quebec Task Force in Spinal Disorders * Must have a score of ≥4 for Low Back Pain Intensity (NRS) while on current treatment at Screening, and completes at least 4 daily pain diaries during the 5 days prior to Randomization, with an average Low Back Pain Intensity (NRS) score of ≥4
Exclusion criteria
* Back pain due to visceral disorder (i.e. endometriosis) or Back pain due to recent major trauma (i.e. vertebral fracture, post-traumatic spondylolisthesis) * History of lumbosacral radiculopathy, spinal stenosis associated with neurological impairment, or neurogenic claudication * Osteoporotic compression fracture within the last 6 months * Known history of: Rheumatoid arthritis; Seronegative spondyloarthropathy (i.e., ankylosing spondylitis, psoriatic arthritis, reactive arthritis, inflammatory bowel disease-related arthropathy); Paget's disease of spine, pelvis or femur; Fibromyalgia; Tumors or infections of the spinal cord * Patients receiving acetaminophen only to manage their chronic low back pain * Any uncontrolled or untreated chronic disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 6 | Baseline, Week 6 | Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain). Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 1, 2, 4, 8 and 12 | Baseline, Week 1, 2, 4, 8, 12 | Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), with lower scores indicating less pain. Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week. |
| Change From Baseline in Average Low Back Pain Intensity (LBPI) Score Over Weeks 1 to 4, 1 to 8, 1 to 12, 5 to 8, and 5 to 12 | Baseline, Weeks 1 to 4, 1 to 8, 1 to 12, 5 to 8, 5 to 12 | Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), with lower scores indicating less pain. Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week. Change from baseline was calculated as the average of each specified week interval (Week 1 to 4, 1 to 8, 1 to 12, 5 to 8, 5 to 12) values minus the baseline value. |
| Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 | Baseline, Week 1, 2, 4, 6, 8, 12 | The mBPI-sf was a self-administered questionnaire used to assess the severity of pain and the impact of pain on daily functions during the 24-hour period prior to evaluation. It consisted of 5 questions. Questions (Q) 1-4 assessed the magnitude of pain (Q1 for worst pain, Q2 for least pain, Q3 for average pain, Q4 for pain right now) on an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine), with lower scores indicating less pain. Question 5 consisted of 7 sub-items (A to G; general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life) which measured the level of interference of pain on daily functions. Each sub-item was assessed on an 11-point NRS ranging from 0 (does not interfere) to 10 (completely interferes). Results are reported for worst and average pain score, each ranging from 0 (no pain) to 10 (pain as bad as you can imagine), with lower scores indicating less pain. |
| Number of Participants With Average Low Back Pain Intensity (LBPI) Score of 2 or Less | Week 1, 2, 4, 6, 8, 12 | Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), with lower scores indicating less pain. Weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week. Participants were classified as responders if average LBPI score was 2 or less, and as non-responders if average LBPI score was greater than (\>) 2. Participants with average LBPI score of 2 or less were reported. |
| Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6 | Week 6 | Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), with lower scores indicating less pain. Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week. Number of participants with cumulative reduction (as percent) (greater than 0% ; \>= 10, 20, 30, 40, 50, 60, 70, 80 and 90%; = 100 %) in Average LBPI score from Baseline at Week 6 were reported, participants (%) are reported more than once in categories specified. |
| Number of Participants With at Least 30% and 50% Sustained Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | Week 12 | Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week. Participants with \>=30% or \>=50% reduction from baseline in daily average LBPI score that was maintained for a minimum duration of 4 consecutive days were reported. |
| Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | Weeks 1, 2, 4, 6, 8, 12 | Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), with lower scores indicating less pain. Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week. Number of participants with \>=30% and \>=50% reduction from Baseline in daily average LBPI score were reported. |
| Time to Achieve at Least 30% and 50% Sustained Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | Randomization to Last Study Visit (up to 16 weeks) | Time to achieve \>=30% or \>=50% sustained reduction from baseline (i.e. reduction from baseline in daily average LBPI score that was maintained for a total of 4 consecutive days) was summarized using the Kaplan-Meier estimates of the median time to 30% and 50% response. Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), with lower scores indicating less pain. Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week. |
| Total Duration of at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | Week 1 up to Week 12 | Total duration of response was defined as the total number of days with \>=30% or \>=50% reduction from baseline in the daily average LBPI score. Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), with lower scores indicating less pain. Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week. |
| Change From Baseline in Roland-Morris Disability Questionnaire Total Score at Week 1, 2, 4, 6, 8, and 12 | Baseline, Week 1, 2, 4, 6, 8, 12 | Roland-Morris Disability Questionnaire: low back pain-specific, participant administered questionnaire that assessed how well participants with low back pain were able to function with regard to daily activities. The questionnaire consisted of 24 statements and the participants were instructed to put a mark next to each appropriate statement if it described their pain on the day of assessment. The number of statements marked were added up by the clinician. Total RMDQ score was calculated as the sum of number of statements checked. Total possible score ranged from 0 to 24, with higher scores indicated greater disability. |
| Duration of Rescue Medication Use | Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 | In case of inadequate pain relief for CLBP or for non-CLBP related pain, acetaminophen up to 2000 mg per day up to 3 days per week could be taken as rescue medication. The number of days of rescue medication use during the particular week were summarized. |
| Amount of Rescue Medication Taken | Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 | In case of inadequate pain relief for CLBP or for non-CLBP related pain, acetaminophen up to 2000 mg per day up to 3 days per week could be taken as rescue medication. The total dosage of acetaminophen (in mg) in each particular week was summarized. |
| Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Baseline, Week 1, 2, 4, 6, 8, 12 | The mBPI-sf was a self-administered questionnaire used to assess the severity of pain and the impact of pain on daily functions during the 24-hour period prior to evaluation. It consisted of 5 questions. Questions 1 to 4 assessed the magnitude of pain (worst, least, average, right now) on an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). Question 5 consisted of 7 sub-items (general activity \[GA\], mood, walking ability \[WA\], normal work \[NW\], relations with other people, sleep, enjoyment of life) which measured the level of interference of pain on daily functions. Each sub-item was assessed on an 11-point NRS ranging from 0 (did not interfere) to 10 (completely interfere). The response from 7 sub-items of question 5 were averaged to obtain pain interference composite score (CS), range: 0 to 10 (higher score=more interference). |
| Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 1, 2, 4, 6, 8, 12 | Patient's global assessment of low back pain scale assessed participants overall impression of disease activity. Participants answered: Considering all the ways your low back pain affects you, how are you doing today? Participants responded using a 5-point Likert scale with a score of 1 being the best (very good) and a score of 5 being the worst (very poor). Participants who reported a change of -4, -3, -2, -1, 0, 1, 2, 3, 4 from Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) score at specified weeks were presented. |
| Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 1, 2, 4, 6, 8, 12 | Participants answered: In all ways, how would you rate your overall response to the study medication today? Participants responded using a 4-point Likert scale where 1 = poor, 2 = fair, 3 = good and 4 = excellent. Higher score indicated better overall response to the treatment. |
| Number of Participants Who Discontinued the Study Due to Lack of Efficacy | Baseline up to Week 12 | — |
| Time to Discontinuation Due to Lack of Efficacy | Baseline up to Week 12 | Median time to discontinuation due to lack of efficacy was estimated using Kaplan-Meier method. Median was not estimable if the percentage of participants who discontinued due to lack of efficacy was below 50%. |
| Number of Participants With Chronic Low Back Pain (CLBP) Response | Weeks 1, 2, 4, 6, 8, 12 | Participants were considered as CLBP responders if they had achieved a reduction of \>=30% in daily average LBPI score from baseline, an increase of \>=30% in patient's global assessment of low back pain (disease activity) from baseline, and no worsening (increase) in RMDQ total score from baseline at specified week. Daily average low back pain assessed on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain). Patient's global assessment of low back pain assessed using a 5-point Likert scale with a score of 1 being the best (very good) and a score of 5 being the worst (very poor). RMDQ: low back pain-specific, participant administered questionnaire consisted of 24 statements and participants were instructed to put a mark next to each appropriate statement if it described their pain on the day of assessment. Total RMDQ score was calculated as sum of number of statements checked. Total possible score ranged from 0 to 24, with higher scores indicated greater disability. |
| Number of Participants Who Used Rescue Medications | Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 | In case of inadequate pain relief for CLBP or for non-CLBP related pain, acetaminophen up to 2000 mg per day up to 3 days per week could be taken as rescue medication. Number of participants with any use of rescue medication during the particular study week were summarized. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Baseline up to 28 days after last dose of study treatment (up to Week 16) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose (up to Week 16) that were absent before treatment or that worsened relative to pretreatment state. |
| Number of Participants With Anti-Drug Antibody (ADA) | Baseline up to Week 12 | Human serum anti-drug antibody (ADA) samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA). |
Countries
United States
Participant flow
Pre-assignment details
Participants underwent a 5-day initial pain assessment period prior to study treatment.
Participants by arm
| Arm | Count |
|---|---|
| Tanezumab Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12. | 88 |
| Naproxen Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12. | 88 |
| Placebo Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12. | 41 |
| Total | 217 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 4 | 3 | 2 |
| Overall Study | Did not met entrance criteria | 1 | 0 | 0 |
| Overall Study | Lack of Efficacy | 7 | 14 | 8 |
| Overall Study | Lost to Follow-up | 4 | 1 | 1 |
| Overall Study | Other | 2 | 0 | 0 |
| Overall Study | Protocol Violation | 1 | 1 | 2 |
| Overall Study | Randomized but not treated | 0 | 1 | 2 |
| Overall Study | Withdrawal by Subject | 10 | 5 | 3 |
Baseline characteristics
| Characteristic | Tanezumab | Naproxen | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 49.5 years STANDARD_DEVIATION 14.7 | 52.1 years STANDARD_DEVIATION 14.8 | 52.2 years STANDARD_DEVIATION 15 | 51.1 years STANDARD_DEVIATION 14.8 |
| Sex: Female, Male Female | 53 Participants | 42 Participants | 23 Participants | 118 Participants |
| Sex: Female, Male Male | 35 Participants | 46 Participants | 18 Participants | 99 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 44 / 88 | 45 / 88 | 27 / 41 |
| serious Total, serious adverse events | 0 / 88 | 2 / 88 | 0 / 41 |
Outcome results
Primary
Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 6
Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain). Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week.
Time frame: Baseline, Week 6
Population: ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo infusion). Here 'number analyzed' signifies participants who were evaluable for this measure at given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 6 | Baseline | 6.48 units on a scale | Standard Deviation 1.42 |
| Tanezumab | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 6 | Change at Week 6 | -3.58 units on a scale | Standard Deviation 1.87 |
| Naproxen | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 6 | Baseline | 6.65 units on a scale | Standard Deviation 1.44 |
| Naproxen | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 6 | Change at Week 6 | -2.69 units on a scale | Standard Deviation 1.98 |
| Placebo | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 6 | Baseline | 6.67 units on a scale | Standard Deviation 1.44 |
| Placebo | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 6 | Change at Week 6 | -2.16 units on a scale | Standard Deviation 2.24 |
Comparison: LS mean difference was estimated from the repeated measures model with baseline, center, treatment, week and treatment-by-week interaction as fixed main effects and participant as random effect.p-value: 0.00180% CI: [-1.67, -0.67]Repeated Measures Model
Secondary
Amount of Rescue Medication Taken
In case of inadequate pain relief for CLBP or for non-CLBP related pain, acetaminophen up to 2000 mg per day up to 3 days per week could be taken as rescue medication. The total dosage of acetaminophen (in mg) in each particular week was summarized.
Time frame: Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Population: Safety population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo infusion). Here 'number analyzed' signifies those participants who were evaluable for this measure at given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | Amount of Rescue Medication Taken | Week 2 | 3221.6 mg | Standard Deviation 3528.1 |
| Tanezumab | Amount of Rescue Medication Taken | Week 5 | 2073.3 mg | Standard Deviation 3100.5 |
| Tanezumab | Amount of Rescue Medication Taken | Week 11 | 1992.2 mg | Standard Deviation 2717.5 |
| Tanezumab | Amount of Rescue Medication Taken | Week 9 | 1772.7 mg | Standard Deviation 2627.1 |
| Tanezumab | Amount of Rescue Medication Taken | Week 6 | 2062.5 mg | Standard Deviation 2919 |
| Tanezumab | Amount of Rescue Medication Taken | Week 1 | 2545.5 mg | Standard Deviation 2798.4 |
| Tanezumab | Amount of Rescue Medication Taken | Week 12 | 1828.1 mg | Standard Deviation 2790.6 |
| Tanezumab | Amount of Rescue Medication Taken | Week 7 | 1854.2 mg | Standard Deviation 3126.9 |
| Tanezumab | Amount of Rescue Medication Taken | Week 10 | 1851.6 mg | Standard Deviation 2655.8 |
| Tanezumab | Amount of Rescue Medication Taken | Week 3 | 2703.7 mg | Standard Deviation 3368.8 |
| Tanezumab | Amount of Rescue Medication Taken | Week 8 | 2134.3 mg | Standard Deviation 3273.6 |
| Tanezumab | Amount of Rescue Medication Taken | Week 4 | 2220.8 mg | Standard Deviation 3108.2 |
| Naproxen | Amount of Rescue Medication Taken | Week 8 | 2212.3 mg | Standard Deviation 3255.2 |
| Naproxen | Amount of Rescue Medication Taken | Week 9 | 2319.4 mg | Standard Deviation 3483.7 |
| Naproxen | Amount of Rescue Medication Taken | Week 11 | 2166.7 mg | Standard Deviation 3632.8 |
| Naproxen | Amount of Rescue Medication Taken | Week 4 | 2475.0 mg | Standard Deviation 2937 |
| Naproxen | Amount of Rescue Medication Taken | Week 12 | 2253.5 mg | Standard Deviation 3402.6 |
| Naproxen | Amount of Rescue Medication Taken | Week 10 | 2513.9 mg | Standard Deviation 3477.3 |
| Naproxen | Amount of Rescue Medication Taken | Week 5 | 2318.8 mg | Standard Deviation 2936.3 |
| Naproxen | Amount of Rescue Medication Taken | Week 2 | 2327.6 mg | Standard Deviation 3083 |
| Naproxen | Amount of Rescue Medication Taken | Week 6 | 2227.3 mg | Standard Deviation 3193.9 |
| Naproxen | Amount of Rescue Medication Taken | Week 1 | 2039.8 mg | Standard Deviation 2467.3 |
| Naproxen | Amount of Rescue Medication Taken | Week 7 | 1873.3 mg | Standard Deviation 2763.3 |
| Naproxen | Amount of Rescue Medication Taken | Week 3 | 2208.3 mg | Standard Deviation 3112.6 |
| Placebo | Amount of Rescue Medication Taken | Week 12 | 1722.2 mg | Standard Deviation 2805.7 |
| Placebo | Amount of Rescue Medication Taken | Week 1 | 2451.2 mg | Standard Deviation 2816.9 |
| Placebo | Amount of Rescue Medication Taken | Week 2 | 2225.0 mg | Standard Deviation 2616.4 |
| Placebo | Amount of Rescue Medication Taken | Week 3 | 2565.8 mg | Standard Deviation 2719.2 |
| Placebo | Amount of Rescue Medication Taken | Week 4 | 2434.2 mg | Standard Deviation 2904.3 |
| Placebo | Amount of Rescue Medication Taken | Week 5 | 2444.4 mg | Standard Deviation 3285.9 |
| Placebo | Amount of Rescue Medication Taken | Week 6 | 2573.5 mg | Standard Deviation 3348.7 |
| Placebo | Amount of Rescue Medication Taken | Week 7 | 2393.9 mg | Standard Deviation 3149.3 |
| Placebo | Amount of Rescue Medication Taken | Week 8 | 1924.2 mg | Standard Deviation 2478.4 |
| Placebo | Amount of Rescue Medication Taken | Week 9 | 1406.3 mg | Standard Deviation 2554.1 |
| Placebo | Amount of Rescue Medication Taken | Week 10 | 1534.5 mg | Standard Deviation 2591 |
| Placebo | Amount of Rescue Medication Taken | Week 11 | 1375.0 mg | Standard Deviation 2311.9 |
Secondary
Change From Baseline in Average Low Back Pain Intensity (LBPI) Score Over Weeks 1 to 4, 1 to 8, 1 to 12, 5 to 8, and 5 to 12
Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), with lower scores indicating less pain. Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week. Change from baseline was calculated as the average of each specified week interval (Week 1 to 4, 1 to 8, 1 to 12, 5 to 8, 5 to 12) values minus the baseline value.
Time frame: Baseline, Weeks 1 to 4, 1 to 8, 1 to 12, 5 to 8, 5 to 12
Population: ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo infusion). Here overall number of participants analyzed signifies those participants who were evaluable for this outcome measure and 'number analyzed' signifies those participants who were evaluable for this measure at given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | Change From Baseline in Average Low Back Pain Intensity (LBPI) Score Over Weeks 1 to 4, 1 to 8, 1 to 12, 5 to 8, and 5 to 12 | Change over Weeks 5 to 8 | -3.56 units on a scale | Standard Deviation 1.91 |
| Tanezumab | Change From Baseline in Average Low Back Pain Intensity (LBPI) Score Over Weeks 1 to 4, 1 to 8, 1 to 12, 5 to 8, and 5 to 12 | Change over Weeks 1 to 12 | -2.92 units on a scale | Standard Deviation 1.85 |
| Tanezumab | Change From Baseline in Average Low Back Pain Intensity (LBPI) Score Over Weeks 1 to 4, 1 to 8, 1 to 12, 5 to 8, and 5 to 12 | Change over Weeks 1 to 4 | -2.59 units on a scale | Standard Deviation 1.75 |
| Tanezumab | Change From Baseline in Average Low Back Pain Intensity (LBPI) Score Over Weeks 1 to 4, 1 to 8, 1 to 12, 5 to 8, and 5 to 12 | Change over Weeks 1 to 8 | -2.86 units on a scale | Standard Deviation 1.81 |
| Tanezumab | Change From Baseline in Average Low Back Pain Intensity (LBPI) Score Over Weeks 1 to 4, 1 to 8, 1 to 12, 5 to 8, and 5 to 12 | Change over Weeks 5 to 12 | -3.48 units on a scale | Standard Deviation 1.94 |
| Naproxen | Change From Baseline in Average Low Back Pain Intensity (LBPI) Score Over Weeks 1 to 4, 1 to 8, 1 to 12, 5 to 8, and 5 to 12 | Change over Weeks 1 to 12 | -2.52 units on a scale | Standard Deviation 1.8 |
| Naproxen | Change From Baseline in Average Low Back Pain Intensity (LBPI) Score Over Weeks 1 to 4, 1 to 8, 1 to 12, 5 to 8, and 5 to 12 | Change over Weeks 1 to 4 | -2.35 units on a scale | Standard Deviation 1.73 |
| Naproxen | Change From Baseline in Average Low Back Pain Intensity (LBPI) Score Over Weeks 1 to 4, 1 to 8, 1 to 12, 5 to 8, and 5 to 12 | Change over Weeks 1 to 8 | -2.47 units on a scale | Standard Deviation 1.75 |
| Naproxen | Change From Baseline in Average Low Back Pain Intensity (LBPI) Score Over Weeks 1 to 4, 1 to 8, 1 to 12, 5 to 8, and 5 to 12 | Change over Weeks 5 to 8 | -2.66 units on a scale | Standard Deviation 1.89 |
| Naproxen | Change From Baseline in Average Low Back Pain Intensity (LBPI) Score Over Weeks 1 to 4, 1 to 8, 1 to 12, 5 to 8, and 5 to 12 | Change over Weeks 5 to 12 | -2.68 units on a scale | Standard Deviation 1.94 |
| Placebo | Change From Baseline in Average Low Back Pain Intensity (LBPI) Score Over Weeks 1 to 4, 1 to 8, 1 to 12, 5 to 8, and 5 to 12 | Change over Weeks 5 to 12 | -2.46 units on a scale | Standard Deviation 2.07 |
| Placebo | Change From Baseline in Average Low Back Pain Intensity (LBPI) Score Over Weeks 1 to 4, 1 to 8, 1 to 12, 5 to 8, and 5 to 12 | Change over Weeks 5 to 8 | -2.38 units on a scale | Standard Deviation 2.07 |
| Placebo | Change From Baseline in Average Low Back Pain Intensity (LBPI) Score Over Weeks 1 to 4, 1 to 8, 1 to 12, 5 to 8, and 5 to 12 | Change over Weeks 1 to 4 | -1.83 units on a scale | Standard Deviation 1.71 |
| Placebo | Change From Baseline in Average Low Back Pain Intensity (LBPI) Score Over Weeks 1 to 4, 1 to 8, 1 to 12, 5 to 8, and 5 to 12 | Change over Weeks 1 to 12 | -2.06 units on a scale | Standard Deviation 1.84 |
| Placebo | Change From Baseline in Average Low Back Pain Intensity (LBPI) Score Over Weeks 1 to 4, 1 to 8, 1 to 12, 5 to 8, and 5 to 12 | Change over Weeks 1 to 8 | -1.97 units on a scale | Standard Deviation 1.8 |
Secondary
Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 1, 2, 4, 8 and 12
Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), with lower scores indicating less pain. Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week.
Time frame: Baseline, Week 1, 2, 4, 8, 12
Population: ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo infusion). Here overall number of participants analyzed signifies those participants who were evaluable for this outcome measure and 'number analyzed' signifies those participants who were evaluable for this measure at given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 1, 2, 4, 8 and 12 | Change at Week 8 | -3.74 units on a scale | Standard Deviation 1.88 |
| Tanezumab | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 1, 2, 4, 8 and 12 | Change at Week 4 | -3.39 units on a scale | Standard Deviation 1.83 |
| Tanezumab | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 1, 2, 4, 8 and 12 | Change at Week 1 | -2.41 units on a scale | Standard Deviation 1.69 |
| Tanezumab | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 1, 2, 4, 8 and 12 | Change at Week 2 | -2.25 units on a scale | Standard Deviation 2.04 |
| Tanezumab | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 1, 2, 4, 8 and 12 | Change at Week 12 | -3.45 units on a scale | Standard Deviation 2.08 |
| Naproxen | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 1, 2, 4, 8 and 12 | Change at Week 4 | -2.57 units on a scale | Standard Deviation 1.86 |
| Naproxen | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 1, 2, 4, 8 and 12 | Change at Week 1 | -2.18 units on a scale | Standard Deviation 1.81 |
| Naproxen | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 1, 2, 4, 8 and 12 | Change at Week 2 | -2.40 units on a scale | Standard Deviation 1.83 |
| Naproxen | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 1, 2, 4, 8 and 12 | Change at Week 8 | -2.79 units on a scale | Standard Deviation 2.06 |
| Naproxen | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 1, 2, 4, 8 and 12 | Change at Week 12 | -2.88 units on a scale | Standard Deviation 2.24 |
| Placebo | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 1, 2, 4, 8 and 12 | Change at Week 12 | -2.68 units on a scale | Standard Deviation 2.4 |
| Placebo | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 1, 2, 4, 8 and 12 | Change at Week 8 | -2.48 units on a scale | Standard Deviation 2.09 |
| Placebo | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 1, 2, 4, 8 and 12 | Change at Week 1 | -1.34 units on a scale | Standard Deviation 1.52 |
| Placebo | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 1, 2, 4, 8 and 12 | Change at Week 4 | -2.23 units on a scale | Standard Deviation 2.07 |
| Placebo | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 1, 2, 4, 8 and 12 | Change at Week 2 | -1.92 units on a scale | Standard Deviation 1.87 |
Secondary
Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12
The mBPI-sf was a self-administered questionnaire used to assess the severity of pain and the impact of pain on daily functions during the 24-hour period prior to evaluation. It consisted of 5 questions. Questions 1 to 4 assessed the magnitude of pain (worst, least, average, right now) on an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). Question 5 consisted of 7 sub-items (general activity \[GA\], mood, walking ability \[WA\], normal work \[NW\], relations with other people, sleep, enjoyment of life) which measured the level of interference of pain on daily functions. Each sub-item was assessed on an 11-point NRS ranging from 0 (did not interfere) to 10 (completely interfere). The response from 7 sub-items of question 5 were averaged to obtain pain interference composite score (CS), range: 0 to 10 (higher score=more interference).
Time frame: Baseline, Week 1, 2, 4, 6, 8, 12
Population: ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo infusion). Here 'number analyzed' signifies those participants who were evaluable for this measure at given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 6: Sleep | -3.92 units on a scale | Standard Deviation 2.54 |
| Tanezumab | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 2: WA | -1.87 units on a scale | Standard Deviation 2.94 |
| Tanezumab | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 12: NW | -3.36 units on a scale | Standard Deviation 2.43 |
| Tanezumab | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 6: NW | -3.55 units on a scale | Standard Deviation 2.04 |
| Tanezumab | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 2: NW | -2.45 units on a scale | Standard Deviation 2.55 |
| Tanezumab | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Baseline: CS | 4.81 units on a scale | Standard Deviation 2.19 |
| Tanezumab | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 6: WA | -3.11 units on a scale | Standard Deviation 2.55 |
| Tanezumab | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 2: Sleep | -2.41 units on a scale | Standard Deviation 2.49 |
| Tanezumab | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 1: CS | -2.52 units on a scale | Standard Deviation 2.13 |
| Tanezumab | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 6: GA | -3.65 units on a scale | Standard Deviation 2.12 |
| Tanezumab | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 4: CS | -3.13 units on a scale | Standard Deviation 2.01 |
| Tanezumab | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Baseline: WA | 4.46 units on a scale | Standard Deviation 2.8 |
| Tanezumab | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 6: CS | -3.25 units on a scale | Standard Deviation 1.85 |
| Tanezumab | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 4: GA | -3.62 units on a scale | Standard Deviation 2.29 |
| Tanezumab | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 12: CS | -3.08 units on a scale | Standard Deviation 2.01 |
| Tanezumab | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 4: Sleep | -3.54 units on a scale | Standard Deviation 2.51 |
| Tanezumab | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 4: WA | -2.87 units on a scale | Standard Deviation 2.5 |
| Tanezumab | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 1: GA | -3.10 units on a scale | Standard Deviation 2.63 |
| Tanezumab | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 4: NW | -3.55 units on a scale | Standard Deviation 2.36 |
| Tanezumab | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Baseline: GA | 5.55 units on a scale | Standard Deviation 2.26 |
| Tanezumab | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 8: Sleep | -3.47 units on a scale | Standard Deviation 2.45 |
| Tanezumab | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 1: WA | -2.35 units on a scale | Standard Deviation 2.64 |
| Tanezumab | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 12: WA | -2.78 units on a scale | Standard Deviation 2.71 |
| Tanezumab | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 8: NW | -3.62 units on a scale | Standard Deviation 2.08 |
| Tanezumab | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 1: NW | -2.75 units on a scale | Standard Deviation 2.41 |
| Tanezumab | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Baseline: NW | 5.15 units on a scale | Standard Deviation 2.48 |
| Tanezumab | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 8: WA | -3.05 units on a scale | Standard Deviation 2.56 |
| Tanezumab | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 1: Sleep | -2.73 units on a scale | Standard Deviation 2.52 |
| Tanezumab | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 12: Sleep | -3.58 units on a scale | Standard Deviation 2.44 |
| Tanezumab | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 8: GA | -3.72 units on a scale | Standard Deviation 2.22 |
| Tanezumab | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 2: CS | -2.17 units on a scale | Standard Deviation 2.13 |
| Tanezumab | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 12: GA | -3.45 units on a scale | Standard Deviation 2.42 |
| Tanezumab | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 8: CS | -3.19 units on a scale | Standard Deviation 1.84 |
| Tanezumab | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 2: GA | -2.61 units on a scale | Standard Deviation 2.58 |
| Tanezumab | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Baseline: Sleep | 5.69 units on a scale | Standard Deviation 2.7 |
| Naproxen | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 12: CS | -2.84 units on a scale | Standard Deviation 2.34 |
| Naproxen | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Baseline: CS | 5.43 units on a scale | Standard Deviation 2.14 |
| Naproxen | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Baseline: GA | 5.83 units on a scale | Standard Deviation 2.25 |
| Naproxen | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Baseline: WA | 5.25 units on a scale | Standard Deviation 2.66 |
| Naproxen | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Baseline: NW | 5.89 units on a scale | Standard Deviation 2.38 |
| Naproxen | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Baseline: Sleep | 5.75 units on a scale | Standard Deviation 2.69 |
| Naproxen | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 1: CS | -2.51 units on a scale | Standard Deviation 2.46 |
| Naproxen | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 1: GA | -2.51 units on a scale | Standard Deviation 2.82 |
| Naproxen | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 1: WA | -2.04 units on a scale | Standard Deviation 2.96 |
| Naproxen | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 1: NW | -2.40 units on a scale | Standard Deviation 2.84 |
| Naproxen | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 1: Sleep | -2.87 units on a scale | Standard Deviation 3.02 |
| Naproxen | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 2: CS | -2.82 units on a scale | Standard Deviation 2.41 |
| Naproxen | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 2: GA | -2.94 units on a scale | Standard Deviation 2.84 |
| Naproxen | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 2: WA | -2.48 units on a scale | Standard Deviation 2.79 |
| Naproxen | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 2: NW | -3.02 units on a scale | Standard Deviation 2.61 |
| Naproxen | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 2: Sleep | -2.88 units on a scale | Standard Deviation 2.7 |
| Naproxen | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 4: CS | -2.52 units on a scale | Standard Deviation 2.35 |
| Naproxen | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 4: GA | -2.58 units on a scale | Standard Deviation 2.72 |
| Naproxen | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 4: WA | -2.09 units on a scale | Standard Deviation 2.72 |
| Naproxen | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 4: NW | -2.63 units on a scale | Standard Deviation 2.65 |
| Naproxen | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 4: Sleep | -2.63 units on a scale | Standard Deviation 3.2 |
| Naproxen | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 6: CS | -2.84 units on a scale | Standard Deviation 2.29 |
| Naproxen | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 6: GA | -2.97 units on a scale | Standard Deviation 2.66 |
| Naproxen | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 6: WA | -2.48 units on a scale | Standard Deviation 2.86 |
| Naproxen | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 6: NW | -2.95 units on a scale | Standard Deviation 2.74 |
| Naproxen | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 6: Sleep | -2.99 units on a scale | Standard Deviation 2.95 |
| Naproxen | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 8: CS | -3.01 units on a scale | Standard Deviation 2.31 |
| Naproxen | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 8: GA | -3.14 units on a scale | Standard Deviation 2.78 |
| Naproxen | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 8: WA | -2.62 units on a scale | Standard Deviation 3.04 |
| Naproxen | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 8: NW | -3.24 units on a scale | Standard Deviation 2.59 |
| Naproxen | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 8: Sleep | -3.51 units on a scale | Standard Deviation 2.93 |
| Naproxen | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 12: GA | -3.01 units on a scale | Standard Deviation 2.93 |
| Naproxen | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 12: WA | -2.54 units on a scale | Standard Deviation 2.87 |
| Naproxen | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 12: NW | -2.97 units on a scale | Standard Deviation 2.63 |
| Naproxen | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 12: Sleep | -3.33 units on a scale | Standard Deviation 2.87 |
| Placebo | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 12: NW | -3.17 units on a scale | Standard Deviation 3.29 |
| Placebo | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 6: NW | -2.87 units on a scale | Standard Deviation 3.12 |
| Placebo | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 2: GA | -2.58 units on a scale | Standard Deviation 3.54 |
| Placebo | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 12: GA | -2.92 units on a scale | Standard Deviation 3.79 |
| Placebo | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 6: Sleep | -3.03 units on a scale | Standard Deviation 2.58 |
| Placebo | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 2: CS | -2.70 units on a scale | Standard Deviation 2.71 |
| Placebo | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Baseline: WA | 5.15 units on a scale | Standard Deviation 2.81 |
| Placebo | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 8: CS | -3.04 units on a scale | Standard Deviation 2.73 |
| Placebo | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 1: Sleep | -2.27 units on a scale | Standard Deviation 2.53 |
| Placebo | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Baseline: CS | 5.29 units on a scale | Standard Deviation 2.25 |
| Placebo | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 8: GA | -2.93 units on a scale | Standard Deviation 3.27 |
| Placebo | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 1: NW | -2.22 units on a scale | Standard Deviation 2.75 |
| Placebo | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 12: WA | -2.04 units on a scale | Standard Deviation 3.48 |
| Placebo | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 8: WA | -2.87 units on a scale | Standard Deviation 3.07 |
| Placebo | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 1: WA | -2.17 units on a scale | Standard Deviation 2.94 |
| Placebo | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Baseline: GA | 5.49 units on a scale | Standard Deviation 2.72 |
| Placebo | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 8: NW | -3.33 units on a scale | Standard Deviation 3.13 |
| Placebo | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 1: GA | -1.88 units on a scale | Standard Deviation 2.47 |
| Placebo | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 12: Sleep | -3.08 units on a scale | Standard Deviation 2.8 |
| Placebo | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 4: WA | -2.81 units on a scale | Standard Deviation 3.04 |
| Placebo | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 8: Sleep | -3.33 units on a scale | Standard Deviation 2.8 |
| Placebo | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 4: NW | -2.81 units on a scale | Standard Deviation 3.25 |
| Placebo | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 4: GA | -2.36 units on a scale | Standard Deviation 3.87 |
| Placebo | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 1: CS | -2.07 units on a scale | Standard Deviation 2.17 |
| Placebo | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 4: Sleep | -3.08 units on a scale | Standard Deviation 2.9 |
| Placebo | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 4: CS | -2.72 units on a scale | Standard Deviation 2.8 |
| Placebo | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Baseline: Sleep | 6.20 units on a scale | Standard Deviation 2.44 |
| Placebo | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 6: CS | -2.76 units on a scale | Standard Deviation 2.61 |
| Placebo | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 2: Sleep | -3.19 units on a scale | Standard Deviation 2.88 |
| Placebo | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 12: CS | -2.74 units on a scale | Standard Deviation 3.15 |
| Placebo | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 6: GA | -2.68 units on a scale | Standard Deviation 3.07 |
| Placebo | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 2: NW | -2.92 units on a scale | Standard Deviation 3.08 |
| Placebo | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Baseline: NW | 5.80 units on a scale | Standard Deviation 2.39 |
| Placebo | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 6: WA | -2.39 units on a scale | Standard Deviation 2.84 |
| Placebo | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 | Change at Week 2: WA | -2.64 units on a scale | Standard Deviation 3.16 |
Secondary
Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12
The mBPI-sf was a self-administered questionnaire used to assess the severity of pain and the impact of pain on daily functions during the 24-hour period prior to evaluation. It consisted of 5 questions. Questions (Q) 1-4 assessed the magnitude of pain (Q1 for worst pain, Q2 for least pain, Q3 for average pain, Q4 for pain right now) on an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine), with lower scores indicating less pain. Question 5 consisted of 7 sub-items (A to G; general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life) which measured the level of interference of pain on daily functions. Each sub-item was assessed on an 11-point NRS ranging from 0 (does not interfere) to 10 (completely interferes). Results are reported for worst and average pain score, each ranging from 0 (no pain) to 10 (pain as bad as you can imagine), with lower scores indicating less pain.
Time frame: Baseline, Week 1, 2, 4, 6, 8, 12
Population: ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo infusion). Here 'number analyzed' signifies those participants who were evaluable for this measure at given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 | Change at Week 8: Worst Pain | -3.85 units on a scale | Standard Deviation 2.37 |
| Tanezumab | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 | Change at Week 2: Average Pain | -1.97 units on a scale | Standard Deviation 2.01 |
| Tanezumab | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 | Change at Week 1: Worst Pain | -2.54 units on a scale | Standard Deviation 2.33 |
| Tanezumab | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 | Change at Week 6: Average Pain | -3.29 units on a scale | Standard Deviation 1.85 |
| Tanezumab | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 | Change at Week 4: Worst Pain | -3.54 units on a scale | Standard Deviation 2.17 |
| Tanezumab | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 | Baseline: Average Pain | 5.99 units on a scale | Standard Deviation 1.43 |
| Tanezumab | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 | Change at Week 6: Worst Pain | -3.67 units on a scale | Standard Deviation 2.45 |
| Tanezumab | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 | Change at Week 4: Average Pain | -2.99 units on a scale | Standard Deviation 1.91 |
| Tanezumab | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 | Change at Week 8: Average Pain | -3.26 units on a scale | Standard Deviation 1.89 |
| Tanezumab | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 | Change at Week 1: Average Pain | -2.09 units on a scale | Standard Deviation 2.07 |
| Tanezumab | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 | Change at Week 12: Average Pain | -3.00 units on a scale | Standard Deviation 1.92 |
| Tanezumab | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 | Baseline: Worst Pain | 6.89 units on a scale | Standard Deviation 1.69 |
| Tanezumab | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 | Change at Week 2: Worst Pain | -2.21 units on a scale | Standard Deviation 2.53 |
| Tanezumab | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 | Change at Week 12: Worst Pain | -3.40 units on a scale | Standard Deviation 2.37 |
| Naproxen | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 | Change at Week 8: Worst Pain | -2.89 units on a scale | Standard Deviation 2.56 |
| Naproxen | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 | Baseline: Worst Pain | 7.02 units on a scale | Standard Deviation 1.74 |
| Naproxen | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 | Baseline: Average Pain | 6.18 units on a scale | Standard Deviation 1.42 |
| Naproxen | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 | Change at Week 1: Worst Pain | -2.40 units on a scale | Standard Deviation 2.02 |
| Naproxen | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 | Change at Week 1: Average Pain | -2.02 units on a scale | Standard Deviation 1.77 |
| Naproxen | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 | Change at Week 2: Worst Pain | -2.67 units on a scale | Standard Deviation 2.24 |
| Naproxen | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 | Change at Week 2: Average Pain | -2.20 units on a scale | Standard Deviation 1.82 |
| Naproxen | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 | Change at Week 4: Worst Pain | -2.57 units on a scale | Standard Deviation 2.29 |
| Naproxen | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 | Change at Week 4: Average Pain | -2.37 units on a scale | Standard Deviation 1.87 |
| Naproxen | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 | Change at Week 6: Worst Pain | -2.87 units on a scale | Standard Deviation 2.34 |
| Naproxen | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 | Change at Week 6: Average Pain | -2.45 units on a scale | Standard Deviation 1.98 |
| Naproxen | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 | Change at Week 8: Average Pain | -2.44 units on a scale | Standard Deviation 2.03 |
| Naproxen | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 | Change at Week 12: Worst Pain | -2.93 units on a scale | Standard Deviation 2.66 |
| Naproxen | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 | Change at Week 12: Average Pain | -2.45 units on a scale | Standard Deviation 2.36 |
| Placebo | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 | Change at Week 12: Worst Pain | -2.83 units on a scale | Standard Deviation 3.17 |
| Placebo | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 | Change at Week 6: Average Pain | -2.65 units on a scale | Standard Deviation 2.39 |
| Placebo | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 | Change at Week 2: Worst Pain | -2.28 units on a scale | Standard Deviation 2.25 |
| Placebo | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 | Change at Week 1: Average Pain | -1.46 units on a scale | Standard Deviation 1.95 |
| Placebo | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 | Change at Week 8: Worst Pain | -2.90 units on a scale | Standard Deviation 2.77 |
| Placebo | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 | Change at Week 1: Worst Pain | -1.88 units on a scale | Standard Deviation 2.38 |
| Placebo | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 | Baseline: Worst Pain | 7.29 units on a scale | Standard Deviation 1.65 |
| Placebo | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 | Change at Week 8: Average Pain | -2.80 units on a scale | Standard Deviation 2.3 |
| Placebo | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 | Baseline: Average Pain | 6.54 units on a scale | Standard Deviation 1.64 |
| Placebo | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 | Change at Week 4: Average Pain | -2.61 units on a scale | Standard Deviation 2.56 |
| Placebo | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 | Change at Week 4: Worst Pain | -2.47 units on a scale | Standard Deviation 3.25 |
| Placebo | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 | Change at Week 12: Average Pain | -2.88 units on a scale | Standard Deviation 2.47 |
| Placebo | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 | Change at Week 6: Worst Pain | -2.29 units on a scale | Standard Deviation 3.3 |
| Placebo | Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 | Change at Week 2: Average Pain | -2.22 units on a scale | Standard Deviation 2.22 |
Secondary
Change From Baseline in Roland-Morris Disability Questionnaire Total Score at Week 1, 2, 4, 6, 8, and 12
Roland-Morris Disability Questionnaire: low back pain-specific, participant administered questionnaire that assessed how well participants with low back pain were able to function with regard to daily activities. The questionnaire consisted of 24 statements and the participants were instructed to put a mark next to each appropriate statement if it described their pain on the day of assessment. The number of statements marked were added up by the clinician. Total RMDQ score was calculated as the sum of number of statements checked. Total possible score ranged from 0 to 24, with higher scores indicated greater disability.
Time frame: Baseline, Week 1, 2, 4, 6, 8, 12
Population: ITT population. Here overall number of participants analyzed signifies those participants who were evaluable for this outcome measure and 'number analyzed' signifies those participants who were evaluable for this measure at given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | Change From Baseline in Roland-Morris Disability Questionnaire Total Score at Week 1, 2, 4, 6, 8, and 12 | Change at Week 1 | -5.21 units on a scale | Standard Deviation 5.24 |
| Tanezumab | Change From Baseline in Roland-Morris Disability Questionnaire Total Score at Week 1, 2, 4, 6, 8, and 12 | Change at Week 6 | -7.88 units on a scale | Standard Deviation 5.39 |
| Tanezumab | Change From Baseline in Roland-Morris Disability Questionnaire Total Score at Week 1, 2, 4, 6, 8, and 12 | Change at Week 4 | -7.24 units on a scale | Standard Deviation 5.33 |
| Tanezumab | Change From Baseline in Roland-Morris Disability Questionnaire Total Score at Week 1, 2, 4, 6, 8, and 12 | Baseline | 12.33 units on a scale | Standard Deviation 4.63 |
| Tanezumab | Change From Baseline in Roland-Morris Disability Questionnaire Total Score at Week 1, 2, 4, 6, 8, and 12 | Change at Week 12 | -7.12 units on a scale | Standard Deviation 6 |
| Tanezumab | Change From Baseline in Roland-Morris Disability Questionnaire Total Score at Week 1, 2, 4, 6, 8, and 12 | Change at Week 8 | -7.93 units on a scale | Standard Deviation 4.97 |
| Tanezumab | Change From Baseline in Roland-Morris Disability Questionnaire Total Score at Week 1, 2, 4, 6, 8, and 12 | Change at Week 2 | -5.17 units on a scale | Standard Deviation 5.59 |
| Naproxen | Change From Baseline in Roland-Morris Disability Questionnaire Total Score at Week 1, 2, 4, 6, 8, and 12 | Change at Week 4 | -4.00 units on a scale | Standard Deviation 4.99 |
| Naproxen | Change From Baseline in Roland-Morris Disability Questionnaire Total Score at Week 1, 2, 4, 6, 8, and 12 | Baseline | 12.36 units on a scale | Standard Deviation 4.8 |
| Naproxen | Change From Baseline in Roland-Morris Disability Questionnaire Total Score at Week 1, 2, 4, 6, 8, and 12 | Change at Week 1 | -3.69 units on a scale | Standard Deviation 5.11 |
| Naproxen | Change From Baseline in Roland-Morris Disability Questionnaire Total Score at Week 1, 2, 4, 6, 8, and 12 | Change at Week 2 | -4.04 units on a scale | Standard Deviation 5.37 |
| Naproxen | Change From Baseline in Roland-Morris Disability Questionnaire Total Score at Week 1, 2, 4, 6, 8, and 12 | Change at Week 6 | -4.69 units on a scale | Standard Deviation 5.34 |
| Naproxen | Change From Baseline in Roland-Morris Disability Questionnaire Total Score at Week 1, 2, 4, 6, 8, and 12 | Change at Week 8 | -5.17 units on a scale | Standard Deviation 5.32 |
| Naproxen | Change From Baseline in Roland-Morris Disability Questionnaire Total Score at Week 1, 2, 4, 6, 8, and 12 | Change at Week 12 | -5.10 units on a scale | Standard Deviation 5.5 |
| Placebo | Change From Baseline in Roland-Morris Disability Questionnaire Total Score at Week 1, 2, 4, 6, 8, and 12 | Change at Week 6 | -4.55 units on a scale | Standard Deviation 6.55 |
| Placebo | Change From Baseline in Roland-Morris Disability Questionnaire Total Score at Week 1, 2, 4, 6, 8, and 12 | Change at Week 1 | -3.76 units on a scale | Standard Deviation 5.25 |
| Placebo | Change From Baseline in Roland-Morris Disability Questionnaire Total Score at Week 1, 2, 4, 6, 8, and 12 | Change at Week 12 | -4.67 units on a scale | Standard Deviation 6.84 |
| Placebo | Change From Baseline in Roland-Morris Disability Questionnaire Total Score at Week 1, 2, 4, 6, 8, and 12 | Change at Week 8 | -5.60 units on a scale | Standard Deviation 6.22 |
| Placebo | Change From Baseline in Roland-Morris Disability Questionnaire Total Score at Week 1, 2, 4, 6, 8, and 12 | Change at Week 4 | -4.31 units on a scale | Standard Deviation 5.81 |
| Placebo | Change From Baseline in Roland-Morris Disability Questionnaire Total Score at Week 1, 2, 4, 6, 8, and 12 | Change at Week 2 | -4.08 units on a scale | Standard Deviation 6.25 |
| Placebo | Change From Baseline in Roland-Morris Disability Questionnaire Total Score at Week 1, 2, 4, 6, 8, and 12 | Baseline | 13.68 units on a scale | Standard Deviation 5.17 |
Secondary
Duration of Rescue Medication Use
In case of inadequate pain relief for CLBP or for non-CLBP related pain, acetaminophen up to 2000 mg per day up to 3 days per week could be taken as rescue medication. The number of days of rescue medication use during the particular week were summarized.
Time frame: Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Population: Safety population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo infusion). Here 'number analyzed' signifies those participants who were evaluable for this measure at given time points.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Tanezumab | Duration of Rescue Medication Use | Week 2 | 2 days |
| Tanezumab | Duration of Rescue Medication Use | Week 3 | 2 days |
| Tanezumab | Duration of Rescue Medication Use | Week 1 | 2 days |
| Tanezumab | Duration of Rescue Medication Use | Week 4 | 1 days |
| Tanezumab | Duration of Rescue Medication Use | Week 5 | 0 days |
| Tanezumab | Duration of Rescue Medication Use | Week 6 | 0.5 days |
| Tanezumab | Duration of Rescue Medication Use | Week 7 | 0 days |
| Tanezumab | Duration of Rescue Medication Use | Week 8 | 0 days |
| Tanezumab | Duration of Rescue Medication Use | Week 9 | 0.5 days |
| Tanezumab | Duration of Rescue Medication Use | Week 10 | 0 days |
| Tanezumab | Duration of Rescue Medication Use | Week 11 | 0.5 days |
| Tanezumab | Duration of Rescue Medication Use | Week 12 | 0 days |
| Naproxen | Duration of Rescue Medication Use | Week 12 | 0 days |
| Naproxen | Duration of Rescue Medication Use | Week 2 | 1 days |
| Naproxen | Duration of Rescue Medication Use | Week 7 | 1 days |
| Naproxen | Duration of Rescue Medication Use | Week 9 | 1 days |
| Naproxen | Duration of Rescue Medication Use | Week 1 | 1 days |
| Naproxen | Duration of Rescue Medication Use | Week 6 | 1 days |
| Naproxen | Duration of Rescue Medication Use | Week 11 | 0 days |
| Naproxen | Duration of Rescue Medication Use | Week 3 | 0.5 days |
| Naproxen | Duration of Rescue Medication Use | Week 8 | 1 days |
| Naproxen | Duration of Rescue Medication Use | Week 5 | 1 days |
| Naproxen | Duration of Rescue Medication Use | Week 4 | 2 days |
| Naproxen | Duration of Rescue Medication Use | Week 10 | 1 days |
| Placebo | Duration of Rescue Medication Use | Week 4 | 2 days |
| Placebo | Duration of Rescue Medication Use | Week 5 | 1 days |
| Placebo | Duration of Rescue Medication Use | Week 10 | 0 days |
| Placebo | Duration of Rescue Medication Use | Week 6 | 1 days |
| Placebo | Duration of Rescue Medication Use | Week 7 | 1 days |
| Placebo | Duration of Rescue Medication Use | Week 8 | 1 days |
| Placebo | Duration of Rescue Medication Use | Week 11 | 0 days |
| Placebo | Duration of Rescue Medication Use | Week 2 | 1.5 days |
| Placebo | Duration of Rescue Medication Use | Week 1 | 1 days |
| Placebo | Duration of Rescue Medication Use | Week 9 | 0 days |
| Placebo | Duration of Rescue Medication Use | Week 3 | 2 days |
| Placebo | Duration of Rescue Medication Use | Week 12 | 1 days |
Secondary
Number of Participants Who Discontinued the Study Due to Lack of Efficacy
Time frame: Baseline up to Week 12
Population: Safety population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo infusion).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tanezumab | Number of Participants Who Discontinued the Study Due to Lack of Efficacy | 7 Participants |
| Naproxen | Number of Participants Who Discontinued the Study Due to Lack of Efficacy | 14 Participants |
| Placebo | Number of Participants Who Discontinued the Study Due to Lack of Efficacy | 8 Participants |
Secondary
Number of Participants Who Used Rescue Medications
In case of inadequate pain relief for CLBP or for non-CLBP related pain, acetaminophen up to 2000 mg per day up to 3 days per week could be taken as rescue medication. Number of participants with any use of rescue medication during the particular study week were summarized.
Time frame: Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Population: Safety population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo infusion). Here 'number analyzed' signifies those participants who were evaluable for this measure at given time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanezumab | Number of Participants Who Used Rescue Medications | Week 1 | 61 Participants |
| Tanezumab | Number of Participants Who Used Rescue Medications | Week 2 | 65 Participants |
| Tanezumab | Number of Participants Who Used Rescue Medications | Week 3 | 54 Participants |
| Tanezumab | Number of Participants Who Used Rescue Medications | Week 4 | 40 Participants |
| Tanezumab | Number of Participants Who Used Rescue Medications | Week 5 | 37 Participants |
| Tanezumab | Number of Participants Who Used Rescue Medications | Week 6 | 36 Participants |
| Tanezumab | Number of Participants Who Used Rescue Medications | Week 7 | 34 Participants |
| Tanezumab | Number of Participants Who Used Rescue Medications | Week 8 | 31 Participants |
| Tanezumab | Number of Participants Who Used Rescue Medications | Week 9 | 33 Participants |
| Tanezumab | Number of Participants Who Used Rescue Medications | Week 10 | 30 Participants |
| Tanezumab | Number of Participants Who Used Rescue Medications | Week 11 | 32 Participants |
| Tanezumab | Number of Participants Who Used Rescue Medications | Week 12 | 30 Participants |
| Naproxen | Number of Participants Who Used Rescue Medications | Week 12 | 33 Participants |
| Naproxen | Number of Participants Who Used Rescue Medications | Week 1 | 50 Participants |
| Naproxen | Number of Participants Who Used Rescue Medications | Week 7 | 38 Participants |
| Naproxen | Number of Participants Who Used Rescue Medications | Week 9 | 38 Participants |
| Naproxen | Number of Participants Who Used Rescue Medications | Week 2 | 49 Participants |
| Naproxen | Number of Participants Who Used Rescue Medications | Week 6 | 42 Participants |
| Naproxen | Number of Participants Who Used Rescue Medications | Week 11 | 31 Participants |
| Naproxen | Number of Participants Who Used Rescue Medications | Week 3 | 42 Participants |
| Naproxen | Number of Participants Who Used Rescue Medications | Week 8 | 39 Participants |
| Naproxen | Number of Participants Who Used Rescue Medications | Week 5 | 46 Participants |
| Naproxen | Number of Participants Who Used Rescue Medications | Week 4 | 49 Participants |
| Naproxen | Number of Participants Who Used Rescue Medications | Week 10 | 41 Participants |
| Placebo | Number of Participants Who Used Rescue Medications | Week 4 | 28 Participants |
| Placebo | Number of Participants Who Used Rescue Medications | Week 5 | 21 Participants |
| Placebo | Number of Participants Who Used Rescue Medications | Week 10 | 14 Participants |
| Placebo | Number of Participants Who Used Rescue Medications | Week 6 | 20 Participants |
| Placebo | Number of Participants Who Used Rescue Medications | Week 7 | 17 Participants |
| Placebo | Number of Participants Who Used Rescue Medications | Week 8 | 19 Participants |
| Placebo | Number of Participants Who Used Rescue Medications | Week 11 | 13 Participants |
| Placebo | Number of Participants Who Used Rescue Medications | Week 1 | 29 Participants |
| Placebo | Number of Participants Who Used Rescue Medications | Week 2 | 27 Participants |
| Placebo | Number of Participants Who Used Rescue Medications | Week 9 | 12 Participants |
| Placebo | Number of Participants Who Used Rescue Medications | Week 3 | 24 Participants |
| Placebo | Number of Participants Who Used Rescue Medications | Week 12 | 16 Participants |
Secondary
Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score
Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), with lower scores indicating less pain. Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week. Number of participants with \>=30% and \>=50% reduction from Baseline in daily average LBPI score were reported.
Time frame: Weeks 1, 2, 4, 6, 8, 12
Population: ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo infusion). LOCF method was used to impute missing values.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanezumab | Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | Week 1: >=30% reduction | 46 Participants |
| Tanezumab | Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | Week 1: >=50% reduction | 28 Participants |
| Tanezumab | Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | Week 2: >=30% reduction | 42 Participants |
| Tanezumab | Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | Week 2: >=50% reduction | 28 Participants |
| Tanezumab | Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | Week 4: >=30% reduction | 62 Participants |
| Tanezumab | Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | Week 4: >=50% reduction | 43 Participants |
| Tanezumab | Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | Week 6: >=30% reduction | 65 Participants |
| Tanezumab | Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | Week 6: >=50% reduction | 50 Participants |
| Tanezumab | Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | Week 8: >=30% reduction | 66 Participants |
| Tanezumab | Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | Week 8: >=50% reduction | 49 Participants |
| Tanezumab | Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | Week 12: >=30% reduction | 59 Participants |
| Tanezumab | Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | Week 12: >=50% reduction | 43 Participants |
| Naproxen | Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | Week 12: >=50% reduction | 30 Participants |
| Naproxen | Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | Week 1: >=30% reduction | 45 Participants |
| Naproxen | Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | Week 6: >=30% reduction | 50 Participants |
| Naproxen | Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | Week 8: >=30% reduction | 51 Participants |
| Naproxen | Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | Week 1: >=50% reduction | 26 Participants |
| Naproxen | Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | Week 4: >=50% reduction | 28 Participants |
| Naproxen | Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | Week 12: >=30% reduction | 45 Participants |
| Naproxen | Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | Week 2: >=30% reduction | 48 Participants |
| Naproxen | Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | Week 6: >=50% reduction | 30 Participants |
| Naproxen | Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | Week 4: >=30% reduction | 50 Participants |
| Naproxen | Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | Week 2: >=50% reduction | 31 Participants |
| Naproxen | Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | Week 8: >=50% reduction | 33 Participants |
| Placebo | Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | Week 2: >=50% reduction | 7 Participants |
| Placebo | Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | Week 4: >=30% reduction | 16 Participants |
| Placebo | Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | Week 8: >=50% reduction | 9 Participants |
| Placebo | Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | Week 4: >=50% reduction | 10 Participants |
| Placebo | Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | Week 6: >=30% reduction | 13 Participants |
| Placebo | Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | Week 6: >=50% reduction | 8 Participants |
| Placebo | Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | Week 12: >=30% reduction | 20 Participants |
| Placebo | Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | Week 1: >=30% reduction | 8 Participants |
| Placebo | Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | Week 1: >=50% reduction | 5 Participants |
| Placebo | Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | Week 8: >=30% reduction | 18 Participants |
| Placebo | Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | Week 2: >=30% reduction | 14 Participants |
| Placebo | Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | Week 12: >=50% reduction | 12 Participants |
Secondary
Number of Participants With at Least 30% and 50% Sustained Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score
Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week. Participants with \>=30% or \>=50% reduction from baseline in daily average LBPI score that was maintained for a minimum duration of 4 consecutive days were reported.
Time frame: Week 12
Population: ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo infusion). Here 'overall number of participants analyzed signifies those participants who were evaluable for this outcome measure
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanezumab | Number of Participants With at Least 30% and 50% Sustained Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | >=30% reduction | 71 Participants |
| Tanezumab | Number of Participants With at Least 30% and 50% Sustained Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | >=50% reduction | 62 Participants |
| Naproxen | Number of Participants With at Least 30% and 50% Sustained Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | >=30% reduction | 60 Participants |
| Naproxen | Number of Participants With at Least 30% and 50% Sustained Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | >=50% reduction | 50 Participants |
| Placebo | Number of Participants With at Least 30% and 50% Sustained Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | >=30% reduction | 26 Participants |
| Placebo | Number of Participants With at Least 30% and 50% Sustained Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | >=50% reduction | 20 Participants |
Secondary
Number of Participants With Average Low Back Pain Intensity (LBPI) Score of 2 or Less
Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), with lower scores indicating less pain. Weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week. Participants were classified as responders if average LBPI score was 2 or less, and as non-responders if average LBPI score was greater than (\>) 2. Participants with average LBPI score of 2 or less were reported.
Time frame: Week 1, 2, 4, 6, 8, 12
Population: ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo infusion). Last observation carried forward (LOCF) method was used to impute missing values.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanezumab | Number of Participants With Average Low Back Pain Intensity (LBPI) Score of 2 or Less | Week 1 | 18 Participants |
| Tanezumab | Number of Participants With Average Low Back Pain Intensity (LBPI) Score of 2 or Less | Week 2 | 20 Participants |
| Tanezumab | Number of Participants With Average Low Back Pain Intensity (LBPI) Score of 2 or Less | Week 4 | 27 Participants |
| Tanezumab | Number of Participants With Average Low Back Pain Intensity (LBPI) Score of 2 or Less | Week 6 | 33 Participants |
| Tanezumab | Number of Participants With Average Low Back Pain Intensity (LBPI) Score of 2 or Less | Week 8 | 32 Participants |
| Tanezumab | Number of Participants With Average Low Back Pain Intensity (LBPI) Score of 2 or Less | Week 12 | 26 Participants |
| Naproxen | Number of Participants With Average Low Back Pain Intensity (LBPI) Score of 2 or Less | Week 12 | 21 Participants |
| Naproxen | Number of Participants With Average Low Back Pain Intensity (LBPI) Score of 2 or Less | Week 1 | 13 Participants |
| Naproxen | Number of Participants With Average Low Back Pain Intensity (LBPI) Score of 2 or Less | Week 6 | 21 Participants |
| Naproxen | Number of Participants With Average Low Back Pain Intensity (LBPI) Score of 2 or Less | Week 8 | 25 Participants |
| Naproxen | Number of Participants With Average Low Back Pain Intensity (LBPI) Score of 2 or Less | Week 2 | 19 Participants |
| Naproxen | Number of Participants With Average Low Back Pain Intensity (LBPI) Score of 2 or Less | Week 4 | 19 Participants |
| Placebo | Number of Participants With Average Low Back Pain Intensity (LBPI) Score of 2 or Less | Week 2 | 4 Participants |
| Placebo | Number of Participants With Average Low Back Pain Intensity (LBPI) Score of 2 or Less | Week 4 | 6 Participants |
| Placebo | Number of Participants With Average Low Back Pain Intensity (LBPI) Score of 2 or Less | Week 12 | 6 Participants |
| Placebo | Number of Participants With Average Low Back Pain Intensity (LBPI) Score of 2 or Less | Week 6 | 5 Participants |
| Placebo | Number of Participants With Average Low Back Pain Intensity (LBPI) Score of 2 or Less | Week 1 | 2 Participants |
| Placebo | Number of Participants With Average Low Back Pain Intensity (LBPI) Score of 2 or Less | Week 8 | 8 Participants |
Secondary
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12
Patient's global assessment of low back pain scale assessed participants overall impression of disease activity. Participants answered: Considering all the ways your low back pain affects you, how are you doing today? Participants responded using a 5-point Likert scale with a score of 1 being the best (very good) and a score of 5 being the worst (very poor). Participants who reported a change of -4, -3, -2, -1, 0, 1, 2, 3, 4 from Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) score at specified weeks were presented.
Time frame: Week 1, 2, 4, 6, 8, 12
Population: ITT population. Here overall number of participants analyzed signifies those participants who were evaluable for this outcome measure and 'number analyzed' signifies those participants who were evaluable for this measure at given time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanezumab | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 4: Change= -4 | 1 Participants |
| Tanezumab | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 1: Change= 2 | 1 Participants |
| Tanezumab | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 6: Change= 4 | 0 Participants |
| Tanezumab | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 4: Change= -3 | 0 Participants |
| Tanezumab | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 1: Change= -2 | 24 Participants |
| Tanezumab | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 6: Change= 3 | 0 Participants |
| Tanezumab | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 4: Change= -2 | 22 Participants |
| Tanezumab | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 12: Change= -2 | 14 Participants |
| Tanezumab | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 6: Change= 2 | 0 Participants |
| Tanezumab | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 4: Change= -1 | 30 Participants |
| Tanezumab | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 1: Change= 3 | 0 Participants |
| Tanezumab | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 6: Change= 1 | 1 Participants |
| Tanezumab | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 4: Change= 0 | 14 Participants |
| Tanezumab | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 12: Change= 4 | 0 Participants |
| Tanezumab | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 6: Change= 0 | 15 Participants |
| Tanezumab | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 4: Change= 1 | 0 Participants |
| Tanezumab | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 12: Change= -3 | 1 Participants |
| Tanezumab | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 6: Change= -1 | 20 Participants |
| Tanezumab | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 4: Change= 2 | 0 Participants |
| Tanezumab | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 1: Change= 4 | 0 Participants |
| Tanezumab | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 6: Change= -2 | 25 Participants |
| Tanezumab | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 4: Change= 3 | 0 Participants |
| Tanezumab | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 12: Change= 2 | 0 Participants |
| Tanezumab | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 6: Change= -3 | 2 Participants |
| Tanezumab | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 4: Change= 4 | 0 Participants |
| Tanezumab | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 12: Change= -4 | 1 Participants |
| Tanezumab | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 6: Change= -4 | 2 Participants |
| Tanezumab | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 2: Change= -4 | 1 Participants |
| Tanezumab | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 1: Change= -1 | 23 Participants |
| Tanezumab | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 8: Change= 4 | 0 Participants |
| Tanezumab | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 2: Change= -3 | 2 Participants |
| Tanezumab | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 1: Change= -3 | 1 Participants |
| Tanezumab | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 8: Change= 3 | 0 Participants |
| Tanezumab | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 2: Change= -2 | 16 Participants |
| Tanezumab | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 12: Change= 1 | 1 Participants |
| Tanezumab | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 8: Change= 2 | 0 Participants |
| Tanezumab | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 2: Change= -1 | 26 Participants |
| Tanezumab | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 1: Change= 0 | 25 Participants |
| Tanezumab | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 8: Change= 1 | 1 Participants |
| Tanezumab | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 2: Change= 0 | 24 Participants |
| Tanezumab | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 1: Change= -4 | 1 Participants |
| Tanezumab | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 8: Change= 0 | 11 Participants |
| Tanezumab | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 2: Change= 1 | 6 Participants |
| Tanezumab | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 12: Change= 0 | 20 Participants |
| Tanezumab | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 8: Change= -1 | 23 Participants |
| Tanezumab | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 2: Change= 2 | 1 Participants |
| Tanezumab | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 1: Change= 1 | 2 Participants |
| Tanezumab | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 8: Change= -2 | 23 Participants |
| Tanezumab | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 2: Change= 3 | 0 Participants |
| Tanezumab | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 12: Change= 3 | 0 Participants |
| Tanezumab | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 8: Change= -3 | 2 Participants |
| Tanezumab | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 2: Change= 4 | 0 Participants |
| Tanezumab | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 12: Change= -1 | 22 Participants |
| Tanezumab | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 8: Change= -4 | 0 Participants |
| Naproxen | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 8: Change= 0 | 19 Participants |
| Naproxen | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 1: Change= -3 | 2 Participants |
| Naproxen | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 1: Change= -2 | 18 Participants |
| Naproxen | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 1: Change= -1 | 33 Participants |
| Naproxen | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 1: Change= 0 | 26 Participants |
| Naproxen | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 1: Change= 1 | 4 Participants |
| Naproxen | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 1: Change= 2 | 1 Participants |
| Naproxen | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 1: Change= 3 | 0 Participants |
| Naproxen | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 1: Change= 4 | 0 Participants |
| Naproxen | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 2: Change= -4 | 1 Participants |
| Naproxen | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 2: Change= -3 | 4 Participants |
| Naproxen | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 2: Change= -2 | 17 Participants |
| Naproxen | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 2: Change= -1 | 30 Participants |
| Naproxen | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 2: Change= 0 | 23 Participants |
| Naproxen | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 2: Change= 1 | 6 Participants |
| Naproxen | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 2: Change= 2 | 1 Participants |
| Naproxen | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 2: Change= 3 | 0 Participants |
| Naproxen | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 2: Change= 4 | 0 Participants |
| Naproxen | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 4: Change= -4 | 1 Participants |
| Naproxen | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 4: Change= -3 | 2 Participants |
| Naproxen | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 4: Change= -2 | 18 Participants |
| Naproxen | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 4: Change= -1 | 32 Participants |
| Naproxen | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 4: Change= 0 | 20 Participants |
| Naproxen | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 4: Change= 1 | 4 Participants |
| Naproxen | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 4: Change= 2 | 2 Participants |
| Naproxen | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 4: Change= 3 | 0 Participants |
| Naproxen | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 4: Change= 4 | 0 Participants |
| Naproxen | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 6: Change= -4 | 0 Participants |
| Naproxen | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 6: Change= -3 | 7 Participants |
| Naproxen | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 6: Change= -2 | 22 Participants |
| Naproxen | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 6: Change= -1 | 18 Participants |
| Naproxen | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 6: Change= 0 | 20 Participants |
| Naproxen | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 6: Change= 1 | 7 Participants |
| Naproxen | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 6: Change= 2 | 1 Participants |
| Naproxen | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 6: Change= 3 | 0 Participants |
| Naproxen | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 6: Change= 4 | 0 Participants |
| Naproxen | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 8: Change= -4 | 0 Participants |
| Naproxen | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 8: Change= -3 | 5 Participants |
| Naproxen | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 8: Change= -2 | 17 Participants |
| Naproxen | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 8: Change= -1 | 25 Participants |
| Naproxen | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 1: Change= -4 | 0 Participants |
| Naproxen | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 8: Change= 1 | 4 Participants |
| Naproxen | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 8: Change= 2 | 1 Participants |
| Naproxen | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 8: Change= 3 | 0 Participants |
| Naproxen | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 8: Change= 4 | 0 Participants |
| Naproxen | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 12: Change= -4 | 0 Participants |
| Naproxen | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 12: Change= -3 | 6 Participants |
| Naproxen | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 12: Change= -2 | 15 Participants |
| Naproxen | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 12: Change= -1 | 21 Participants |
| Naproxen | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 12: Change= 0 | 14 Participants |
| Naproxen | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 12: Change= 1 | 11 Participants |
| Naproxen | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 12: Change= 2 | 0 Participants |
| Naproxen | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 12: Change= 3 | 0 Participants |
| Naproxen | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 12: Change= 4 | 0 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 2: Change= 4 | 0 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 1: Change= 1 | 3 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 8: Change= -4 | 0 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 2: Change= 3 | 0 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 1: Change= -3 | 1 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 8: Change= -3 | 2 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 2: Change= 2 | 0 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 12: Change= -1 | 9 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 8: Change= -2 | 6 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 2: Change= 1 | 2 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 1: Change= 0 | 17 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 8: Change= -1 | 14 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 2: Change= 0 | 8 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 12: Change= 4 | 0 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 8: Change= 0 | 4 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 2: Change= -1 | 17 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 12: Change= 0 | 7 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 8: Change= 1 | 4 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 2: Change= -2 | 5 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 1: Change= -1 | 14 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 8: Change= 2 | 0 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 2: Change= -3 | 4 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 12: Change= 3 | 0 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 8: Change= 3 | 0 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 2: Change= -4 | 0 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 12: Change= 1 | 1 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 8: Change= 4 | 0 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 4: Change= 4 | 0 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 1: Change= 4 | 0 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 6: Change= -4 | 0 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 4: Change= 3 | 0 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 1: Change= -2 | 6 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 6: Change= -3 | 3 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 4: Change= 2 | 0 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 12: Change= -4 | 0 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 6: Change= -2 | 5 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 4: Change= 1 | 3 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 1: Change= 3 | 0 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 6: Change= -1 | 12 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 4: Change= 0 | 7 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 1: Change= -4 | 0 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 6: Change= 0 | 10 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 4: Change= -1 | 15 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 12: Change= -3 | 4 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 6: Change= 1 | 1 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 4: Change= -2 | 6 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 1: Change= 2 | 0 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 6: Change= 2 | 0 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 4: Change= -3 | 5 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 12: Change= 2 | 1 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 6: Change= 3 | 0 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 4: Change= -4 | 0 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 12: Change= -2 | 2 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 | Week 6: Change= 4 | 0 Participants |
Secondary
Number of Participants With Chronic Low Back Pain (CLBP) Response
Participants were considered as CLBP responders if they had achieved a reduction of \>=30% in daily average LBPI score from baseline, an increase of \>=30% in patient's global assessment of low back pain (disease activity) from baseline, and no worsening (increase) in RMDQ total score from baseline at specified week. Daily average low back pain assessed on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain). Patient's global assessment of low back pain assessed using a 5-point Likert scale with a score of 1 being the best (very good) and a score of 5 being the worst (very poor). RMDQ: low back pain-specific, participant administered questionnaire consisted of 24 statements and participants were instructed to put a mark next to each appropriate statement if it described their pain on the day of assessment. Total RMDQ score was calculated as sum of number of statements checked. Total possible score ranged from 0 to 24, with higher scores indicated greater disability.
Time frame: Weeks 1, 2, 4, 6, 8, 12
Population: ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo infusion). LOCF method was used to impute missing values. Here overall number of participants analyzed signifies those participants who were evaluable for this outcome measure
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanezumab | Number of Participants With Chronic Low Back Pain (CLBP) Response | Week 1 | 33 Participants |
| Tanezumab | Number of Participants With Chronic Low Back Pain (CLBP) Response | Week 2 | 32 Participants |
| Tanezumab | Number of Participants With Chronic Low Back Pain (CLBP) Response | Week 4 | 51 Participants |
| Tanezumab | Number of Participants With Chronic Low Back Pain (CLBP) Response | Week 6 | 50 Participants |
| Tanezumab | Number of Participants With Chronic Low Back Pain (CLBP) Response | Week 8 | 48 Participants |
| Tanezumab | Number of Participants With Chronic Low Back Pain (CLBP) Response | Week 12 | 38 Participants |
| Naproxen | Number of Participants With Chronic Low Back Pain (CLBP) Response | Week 12 | 30 Participants |
| Naproxen | Number of Participants With Chronic Low Back Pain (CLBP) Response | Week 1 | 30 Participants |
| Naproxen | Number of Participants With Chronic Low Back Pain (CLBP) Response | Week 6 | 39 Participants |
| Naproxen | Number of Participants With Chronic Low Back Pain (CLBP) Response | Week 8 | 36 Participants |
| Naproxen | Number of Participants With Chronic Low Back Pain (CLBP) Response | Week 2 | 34 Participants |
| Naproxen | Number of Participants With Chronic Low Back Pain (CLBP) Response | Week 4 | 31 Participants |
| Placebo | Number of Participants With Chronic Low Back Pain (CLBP) Response | Week 2 | 9 Participants |
| Placebo | Number of Participants With Chronic Low Back Pain (CLBP) Response | Week 4 | 11 Participants |
| Placebo | Number of Participants With Chronic Low Back Pain (CLBP) Response | Week 12 | 12 Participants |
| Placebo | Number of Participants With Chronic Low Back Pain (CLBP) Response | Week 6 | 9 Participants |
| Placebo | Number of Participants With Chronic Low Back Pain (CLBP) Response | Week 1 | 6 Participants |
| Placebo | Number of Participants With Chronic Low Back Pain (CLBP) Response | Week 8 | 14 Participants |
Secondary
Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6
Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), with lower scores indicating less pain. Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week. Number of participants with cumulative reduction (as percent) (greater than 0% ; \>= 10, 20, 30, 40, 50, 60, 70, 80 and 90%; = 100 %) in Average LBPI score from Baseline at Week 6 were reported, participants (%) are reported more than once in categories specified.
Time frame: Week 6
Population: ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo infusion). LOCF method was used to impute missing values.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanezumab | Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6 | >=70% reduction | 25 Participants |
| Tanezumab | Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6 | >=40% reduction | 58 Participants |
| Tanezumab | Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6 | >=90% reduction | 10 Participants |
| Tanezumab | Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6 | >=60% reduction | 40 Participants |
| Tanezumab | Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6 | >=50% reduction | 50 Participants |
| Tanezumab | Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6 | Greater than 0% reduction | 79 Participants |
| Tanezumab | Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6 | >=20% reduction | 68 Participants |
| Tanezumab | Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6 | Greater than or equal to (>=)10% reduction | 75 Participants |
| Tanezumab | Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6 | >=80% reduction | 16 Participants |
| Tanezumab | Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6 | >=30% reduction | 65 Participants |
| Tanezumab | Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6 | 100% reduction | 6 Participants |
| Naproxen | Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6 | >=50% reduction | 30 Participants |
| Naproxen | Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6 | Greater than 0% reduction | 77 Participants |
| Naproxen | Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6 | Greater than or equal to (>=)10% reduction | 72 Participants |
| Naproxen | Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6 | >=20% reduction | 64 Participants |
| Naproxen | Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6 | >=30% reduction | 50 Participants |
| Naproxen | Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6 | >=40% reduction | 41 Participants |
| Naproxen | Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6 | >=60% reduction | 26 Participants |
| Naproxen | Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6 | >=70% reduction | 16 Participants |
| Naproxen | Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6 | >=80% reduction | 9 Participants |
| Naproxen | Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6 | >=90% reduction | 5 Participants |
| Naproxen | Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6 | 100% reduction | 3 Participants |
| Placebo | Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6 | >=90% reduction | 1 Participants |
| Placebo | Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6 | >=70% reduction | 5 Participants |
| Placebo | Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6 | >=20% reduction | 21 Participants |
| Placebo | Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6 | Greater than 0% reduction | 34 Participants |
| Placebo | Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6 | >=80% reduction | 3 Participants |
| Placebo | Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6 | Greater than or equal to (>=)10% reduction | 29 Participants |
| Placebo | Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6 | >=50% reduction | 8 Participants |
| Placebo | Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6 | >=40% reduction | 12 Participants |
| Placebo | Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6 | 100% reduction | 0 Participants |
| Placebo | Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6 | >=60% reduction | 7 Participants |
| Placebo | Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6 | >=30% reduction | 13 Participants |
Secondary
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication
Participants answered: In all ways, how would you rate your overall response to the study medication today? Participants responded using a 4-point Likert scale where 1 = poor, 2 = fair, 3 = good and 4 = excellent. Higher score indicated better overall response to the treatment.
Time frame: Week 1, 2, 4, 6, 8, 12
Population: ITT population. Here overall number of participants analyzed signifies those participants who were evaluable for this outcome measure and 'number analyzed' signifies those participants who were evaluable for this measure at given time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanezumab | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 12: Poor | 6 Participants |
| Tanezumab | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 4: Poor | 4 Participants |
| Tanezumab | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 8: Poor | 1 Participants |
| Tanezumab | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 1: Poor | 7 Participants |
| Tanezumab | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 4: Fair | 5 Participants |
| Tanezumab | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 1: Good | 29 Participants |
| Tanezumab | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 1: Excellent | 26 Participants |
| Tanezumab | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 4: Good | 30 Participants |
| Tanezumab | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 12: Fair | 9 Participants |
| Tanezumab | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 2: Good | 31 Participants |
| Tanezumab | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 4: Excellent | 29 Participants |
| Tanezumab | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 2: Excellent | 19 Participants |
| Tanezumab | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 1: Fair | 16 Participants |
| Tanezumab | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 6: Poor | 1 Participants |
| Tanezumab | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 12: Good | 21 Participants |
| Tanezumab | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 2: Poor | 10 Participants |
| Tanezumab | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 6: Fair | 10 Participants |
| Tanezumab | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 8: Excellent | 32 Participants |
| Tanezumab | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 8: Fair | 8 Participants |
| Tanezumab | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 6: Good | 22 Participants |
| Tanezumab | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 12: Excellent | 23 Participants |
| Tanezumab | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 8: Good | 20 Participants |
| Tanezumab | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 6: Excellent | 32 Participants |
| Tanezumab | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 2: Fair | 17 Participants |
| Naproxen | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 6: Excellent | 18 Participants |
| Naproxen | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 8: Poor | 9 Participants |
| Naproxen | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 2: Fair | 14 Participants |
| Naproxen | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 8: Fair | 24 Participants |
| Naproxen | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 1: Poor | 13 Participants |
| Naproxen | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 8: Good | 19 Participants |
| Naproxen | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 8: Excellent | 19 Participants |
| Naproxen | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 2: Good | 34 Participants |
| Naproxen | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 12: Poor | 15 Participants |
| Naproxen | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 12: Fair | 17 Participants |
| Naproxen | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 12: Good | 18 Participants |
| Naproxen | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 2: Excellent | 18 Participants |
| Naproxen | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 12: Excellent | 17 Participants |
| Naproxen | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 1: Good | 32 Participants |
| Naproxen | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 4: Poor | 15 Participants |
| Naproxen | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 4: Fair | 16 Participants |
| Naproxen | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 4: Good | 27 Participants |
| Naproxen | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 1: Excellent | 17 Participants |
| Naproxen | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 4: Excellent | 21 Participants |
| Naproxen | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 6: Poor | 11 Participants |
| Naproxen | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 6: Fair | 23 Participants |
| Naproxen | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 2: Poor | 16 Participants |
| Naproxen | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 6: Good | 23 Participants |
| Naproxen | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 1: Fair | 22 Participants |
| Placebo | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 6: Good | 14 Participants |
| Placebo | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 1: Poor | 12 Participants |
| Placebo | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 1: Fair | 11 Participants |
| Placebo | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 1: Good | 14 Participants |
| Placebo | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 1: Excellent | 3 Participants |
| Placebo | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 2: Poor | 6 Participants |
| Placebo | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 2: Fair | 11 Participants |
| Placebo | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 2: Good | 15 Participants |
| Placebo | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 2: Excellent | 4 Participants |
| Placebo | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 4: Poor | 8 Participants |
| Placebo | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 4: Fair | 10 Participants |
| Placebo | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 4: Good | 13 Participants |
| Placebo | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 4: Excellent | 5 Participants |
| Placebo | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 6: Poor | 8 Participants |
| Placebo | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 6: Fair | 5 Participants |
| Placebo | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 12: Excellent | 7 Participants |
| Placebo | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 6: Excellent | 4 Participants |
| Placebo | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 8: Poor | 6 Participants |
| Placebo | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 8: Fair | 7 Participants |
| Placebo | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 8: Good | 13 Participants |
| Placebo | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 8: Excellent | 4 Participants |
| Placebo | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 12: Poor | 6 Participants |
| Placebo | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 12: Fair | 6 Participants |
| Placebo | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Week 12: Good | 5 Participants |
Secondary
Time to Achieve at Least 30% and 50% Sustained Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score
Time to achieve \>=30% or \>=50% sustained reduction from baseline (i.e. reduction from baseline in daily average LBPI score that was maintained for a total of 4 consecutive days) was summarized using the Kaplan-Meier estimates of the median time to 30% and 50% response. Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), with lower scores indicating less pain. Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week.
Time frame: Randomization to Last Study Visit (up to 16 weeks)
Population: ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo infusion). Here overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Tanezumab | Time to Achieve at Least 30% and 50% Sustained Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | Time to >=30% reduction | 8 days |
| Tanezumab | Time to Achieve at Least 30% and 50% Sustained Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | Time to >=50% reduction | 18 days |
| Naproxen | Time to Achieve at Least 30% and 50% Sustained Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | Time to >=30% reduction | 7 days |
| Naproxen | Time to Achieve at Least 30% and 50% Sustained Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | Time to >=50% reduction | 41 days |
| Placebo | Time to Achieve at Least 30% and 50% Sustained Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | Time to >=30% reduction | 17 days |
| Placebo | Time to Achieve at Least 30% and 50% Sustained Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | Time to >=50% reduction | 65 days |
Secondary
Time to Discontinuation Due to Lack of Efficacy
Median time to discontinuation due to lack of efficacy was estimated using Kaplan-Meier method. Median was not estimable if the percentage of participants who discontinued due to lack of efficacy was below 50%.
Time frame: Baseline up to Week 12
Population: Safety population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo infusion).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tanezumab | Time to Discontinuation Due to Lack of Efficacy | NA days |
| Naproxen | Time to Discontinuation Due to Lack of Efficacy | NA days |
| Placebo | Time to Discontinuation Due to Lack of Efficacy | NA days |
Secondary
Total Duration of at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score
Total duration of response was defined as the total number of days with \>=30% or \>=50% reduction from baseline in the daily average LBPI score. Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), with lower scores indicating less pain. Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week.
Time frame: Week 1 up to Week 12
Population: ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo infusion).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | Total Duration of at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | Total duration for >=30% reduction | 43.91 days | Standard Error 3.54 |
| Tanezumab | Total Duration of at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | Total duration for >=50% reduction | 33.21 days | Standard Error 3.3 |
| Naproxen | Total Duration of at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | Total duration for >=30% reduction | 38.81 days | Standard Error 3.59 |
| Naproxen | Total Duration of at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | Total duration for >=50% reduction | 27.58 days | Standard Error 3.34 |
| Placebo | Total Duration of at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | Total duration for >=30% reduction | 33.13 days | Standard Error 4.82 |
| Placebo | Total Duration of at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score | Total duration for >=50% reduction | 22.08 days | Standard Error 4.49 |
Other Pre-specified
Number of Participants With Anti-Drug Antibody (ADA)
Human serum anti-drug antibody (ADA) samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA).
Time frame: Baseline up to Week 12
Population: Safety population included all randomized participants who received the Day 1 intravenous infusion of tanezumab. Data for this outcome measure was not planned to be collected and analyzed for Naproxen and Placebo arms.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tanezumab | Number of Participants With Anti-Drug Antibody (ADA) | 0 Participants |
Other Pre-specified
Number of Participants With Treatment-Emergent Adverse Events (AEs) or 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 28 days after last dose (up to Week 16) that were absent before treatment or that worsened relative to pretreatment state.
Time frame: Baseline up to 28 days after last dose of study treatment (up to Week 16)
Population: Safety population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo infusion).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanezumab | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | AEs | 50 Participants |
| Tanezumab | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Naproxen | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | AEs | 54 Participants |
| Naproxen | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | SAEs | 2 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | AEs | 27 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | SAEs | 0 Participants |