Long Term Safety and Efficacy Study of Tanezumab in Japanese Adult Subjects With Chronic Low Back Pain

Study Overview
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Brief Summary
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This study will investigate the long-term safety and efficacy of a fixed dose of tanezumab 5 mg and 10 mg administered subcutaneously (SC) seven times at 8 week intervals. The primary objective of this study is to evaluate the long term safety of tanezumab 5 mg and 10 mg administrated SC every 8 weeks (7 administrations). In addition, the study will evaluate the long term analgesic efficacy of tanezumab 5 mg and 10 mg SC administered every 8 weeks (7 administrations).

Detailed Description
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This is a randomized, double-blind, active-controlled, multicenter, parallel-group Phase 3 study of the safety and efficacy of tanezumab when administered by SC injection for up to 56 weeks in subjects with chronic low back pain. Subjects will be randomized to 1 of 3 treatment groups in a 1:1:1 ratio. Treatment groups will include: 1) Placebo SC matching tanezumab administered at an 8-week interval (total of 7 times) plus celecoxib 100 mg twice a day (BID) to be administered orally for 56 weeks; 2) Tanezumab 5 mg SC administered at an 8-week interval (total of 7 times) plus placebo matching celecoxib to be administered orally BID for 56 weeks; 3) Tanezumab 10 mg SC administered at an 8-week interval (total of 7 times) plus placebo matching celecoxib to be administered orally BID for 56 weeks. The study is designed with a total duration (post-randomization) of up to 80 weeks and will consist of three periods: Screening (up to 37 days; includes a Washout Period and an Initial Pain Assessment Period [IPAP]), a Double-blind Treatment Period (56 weeks) and a Follow-up Period (24 weeks). The Screening Period (beginning up to 37 days prior to Randomization) includes a Washout Period (lasting 2 to 32 days), if required, and an IPAP (the 5 days prior to Randomization/Baseline). Prior to entering the study, subjects must be experiencing some benefit (eg, analgesic effect) from their current stable dose regimen of oral NSAID (celecoxib, loxoprofen or meloxicam) treatment, be tolerating their NSAID regimen, be taking this medication regularly (defined as an average of at least 5 days per week) during the 30 day period prior to the Screening Visit.

Official Title
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A PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED, MULTICENTER STUDY OF THE LONG-TERM SAFETY AND EFFICACY OF SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB IN JAPANESE ADULT SUBJECTS WITH CHRONIC LOW BACK PAIN

Conditions
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Low Back Pain

Intervention / Treatment
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* Drug: Celecoxib
* Biological: Tanezumab 5 mg
* Biological: Tanezumab 10 mg
* Drug: Placebo for celecoxib
* Biological: Placebo for tanezumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Duration of chronic low back pain for ≥3 months, and treatment with agents for low back pain for ≥3 months. Primary location of low back pain must be between the 12th thoracic vertebra and the lower gluteal folds, with or without radiation into the posterior thigh, classified as Category 1 or 2 according to the classification of the Quebec Task Force in Spinal Disorders. Subjects must be experiencing some benefits from their current stable dose regimen of oral NSAID (celecoxib, loxoprofen or meloxicam) treatment as described in the protocol, be tolerating their NSAID regimen, be taking this medication regularly during the 30 day period prior to the Screening visit and must have had some improvement in low back pain, but still require additional pain relief at Screening. Subjects must maintain a stabilized, protocol specified NSAID dose regimen for at least the final 2 or 3 weeks of the Screening period. Low Back Pain Intensity (LBPI) score of ≥5 at Screening. Subjects must be willing to discontinue all pain medications for chronic low back pain except rescue medication and investigational product and not use prohibited pain medications throughout the duration of the study. Female subjects of childbearing potential and at risk for pregnancy must agree to comply with protocol specified contraceptive requirements. Exclusion Criteria: Subjects exceeding protocol defined BMI limits. Diagnosis of osteoarthritis of the knee or hip as defined by the ACR combined clinical and radiographic criteria. Subjects who have Kellgren Lawrence Grade > or =2 radiographic evidence of hip or Grade > or =3 radiographic evidence of knee osteoarthritis will be excluded. Subjects who have Kellgren Lawrence Grade < or =2 radiographic evidence of knee osteoarthritis but who do not meet ACR criteria and do not have pain associated with their knee osteoarthritis will be allowed. Subjects with symptoms and radiologic findings consistent with osteoarthritis in the shoulder. History of lumbosacral radiculopathy within the past 2 years, history of spinal stenosis associated with neurological impairment, or history of neurogenic claudication. Back pain due to recent major trauma within 6 months prior to Screening. Surgical intervention during the past 6 months for the treatment of low back pain. Planned surgical procedure during the duration of the study. History or radiographic evidence of other diseases that could confound efficacy or safety assessments (eg, rheumatoid arthritis). History or radiographic evidence of orthopedic conditions that may increase the risk of, or confound assessment of joint safety conditions during the study. History of osteonecrosis or osteoporotic fracture. History of significant trauma or surgery to a knee, hip, or shoulder within the previous year. Signs or symptoms of carpal tunnel syndrome in the one year prior to Screening. Considered unfit for surgery based upon American Society of Anesthesiologists physical classification system for surgery grading, or subjects who would not be willing to undergo joint replacement surgery if required. History of intolerance or hypersensitivity to celecoxib/acetaminophen or any of its excipients or existence of a medical condition or use of concomitant medication for which the use of celecoxib/acetaminophen is contraindicated. Use of prohibited medications or prohibited non-pharmacological treatments without the appropriate washout period (if applicable) prior to Screening or IPAP. History of known alcohol, analgesic or narcotic abuse within 2 years of Screening. Presence of drugs of abuse or illegal drugs in the urine toxicology screen obtained at Screening. History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG-fusion protein. Signs and symptoms of clinically significant cardiac disease. Poorly controlled hypertension as defined in the protocol or taking an antihypertensive that has not been stable for at least 1 month prior to Screening. Evidence of protocol defined orthostatic hypotension at Screening. Disqualifying score on the Survey of Autonomic Symptoms questionnaire at Screening. Diagnosis of a transient ischemic attack in the 6 months prior to Screening, diagnosis of stroke with residual deficits that would preclude completion of required study activities. History of cancer within 5 years prior to Screening, except for cutaneous basal cell or squamous cell cancer resolved by excision. Expected to undergo a therapeutic procedure or to use any analgesic other than those specified in the protocol throughout the pre-treatment and treatment periods that is likely to confound assessment of analgesic efficacy or safety. Previous exposure to exogenous NGF or to an anti-NGF antibody. Screening AST, ALT, serum creatinine or HbA1c values that exceed protocol defined limits. Positive Hepatitis B, Hepatitis C, or HIV tests at screening indicative of current infection. History, diagnosis, or signs and symptoms of clinically significant neurological disease or clinically significant psychiatric disorder. Pregnant, breastfeeding or female subjects of childbearing potential who are unwilling or unable to follow protocol required contraceptive requirements. Participation in other investigational drug studies within protocol defined time limits. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that in the judgment of the investigator, would make the subject inappropriate for entry into this study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Celecoxib<br>Subcutaneous injection of placebo for tanezumab every 8 weeks plus oral celecoxib 100 mg twice daily for 56 weeks | Drug: Celecoxib<br>* Orally administered Celecoxib 100 mg twice daily for 56 weeks<br>Biological: Placebo for tanezumab<br>* Subcutaneous injection of the placebo every 8 weeks for 56 weeks<br>|
| Experimental: Tanezumab 5 mg<br>Subcutaneous injection of tanezumab 5 mg every 8 weeks plus oral placebo for celecoxib twice daily for 56 weeks | Biological: Tanezumab 5 mg<br>* Subcutaneous injection of tanezumab 5 mg every 8 weeks for 56 weeks<br>Drug: Placebo for celecoxib<br>* Orally administered the placebo twice daily for 56 weeks<br>|
| Experimental: Tanezumab 10 mg<br>Subcutaneous injection of tanezumab 10 mg every 8 weeks plus oral placebo for celecoxib twice daily for 56 weeks | Biological: Tanezumab 10 mg<br>* Subcutaneous injection of tanezumab 10 mg every 8 weeks for 56 weeks<br>Drug: Placebo for celecoxib<br>* Orally administered the placebo twice daily for 56 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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 were events between first dose of study drug and up to 24 weeks after last dose of study drug (up to Week 80) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs. | Baseline (Day 1) up to 24 weeks after last dose of study drug (up to Week 80) | 
| Number of Participants With Treatment-Emergent Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | Treatment-related AE was any untoward medical occurrence attributed to study drug in participant who received study drug. 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 were events between first dose of study drug and up to 24 weeks after last dose of study drug (up to Week 80). Relatedness to study drug was assessed by the investigator. AEs included both serious and non-serious AEs. | Baseline up to 24 weeks after last dose of study drug (up to Week 80) | 
| Number of Participants With Clinically Significant Laboratory Test Abnormalities | Abnormality criteria included: hemoglobin (HGB); hematocrit; erythrocytes < 0.8*lower limit of normal (LLN); erythrocyte mean corpuscular volume/HGB/ HGB concentration, erythrocytes distribution width <0.9*LLN, >1.1*upper limit of normal (ULN); platelets <0.5*LLN,>1.75* ULN; white blood cell count<0.6*LLN, >1.5*ULN; lymphocytes, leukocytes, neutrophils <0.8*LLN, >1.2*ULN; basophils, eosinophils, monocytes >1.2*ULN; total bilirubin>1.5*ULN; aspartate aminotransferase (AT), alanine AT, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase >3.0*ULN; total protein; albumin<0.8*LLN, >1.2*ULN; blood urea nitrogen, creatinine, cholesterol, triglycerides >1.3*ULN; urate >1.2*ULN; sodium <0.95*LLN,>1.05*ULN; potassium, chloride, calcium, magnesium, bicarbonate <0.9*LLN, >1.1*ULN; phosphate <0.8*LLN, >1.2*ULN; glucose <0.6*LLN, >1.5*ULN; HGB A1C >1.3*ULN; creatine kinase >2.0*ULN; nitrite >=1. Investigator judged clinical significance of laboratory test abnormalities. | Baseline up to Week 80 | 
| Number of Participants With Clinically Significant Vital Signs Abnormalities | Vital signs included systolic blood pressure, diastolic blood pressure and pulse rate. Investigator judged clinical significance of vital signs' abnormalities. | Baseline up to Week 80 | 
| Number of Participants With Confirmed Orthostatic Hypotension From Baseline up to Week 80 | Orthostatic hypotension was defined as postural change (supine to standing) that met the following criteria: for systolic blood pressure (BP) less than or equal to (<=) 150 millimeter of mercury (mmHg) (mean supine): reduction in systolic BP >=20 mmHg or reduction in diastolic BP >=10 mmHg at the 1 and/or 3 minute standing BP measurements. For systolic BP greater than (>) 150 mmHg (mean supine): reduction in systolic BP >=30 mmHg or reduction in diastolic BP >=15 mmHg at the 1 and/or 3 minute standing BP measurements. If the 1 minute or 3 minute standing BP in a sequence met the orthostatic hypotension criteria, then that sequence was considered positive. If 2 of 2 or 2 of 3 sequences were positive, then orthostatic hypotension was considered confirmed. | Baseline up to Week 80 | 
| Change From Screening in Mean Total Symptom Impact Score as Per Survey of Autonomic Symptoms (SAS) at Week 24 | SAS is a participant rated 12 items questionnaire for males and 11 items questionnaire for females. SAS measures autonomic symptoms of neuropathy and their impact on participants' well-being, during the past 6 months. Each item was related to a symptom/health problem. At scheduled time points, participants were asked to answer Yes or No for each of symptoms/health problems experienced during past 6 months. If a participant answered Yes for a symptom, then impact of that symptom was rated on a 5 point scale, ranged from 1 (least sever impact) to 5 (most severe impact), where higher scores signified more severe impact of symptoms. The total symptom impact score was calculated as the sum of impact of all symptoms. Overall possible range for the total symptom impact score was 0 (no impact) to 60 (extreme impact) for males and 0 (no impact) to 55 (extreme impact) for females, higher scores indicated more severe impact of symptoms on participants' well-being. | Screening (up to 37 days before Day 1), Week 24 | 
| Change From Screening in Mean Total Symptom Impact Score as Per Survey of Autonomic Symptoms (SAS) at Week 56 | SAS is a participant rated 12 items questionnaire for males and 11 items questionnaire for females. SAS measures autonomic symptoms of neuropathy and their impact on participants' well-being, during the past 6 months. Each item was related to a symptom/health problem. At scheduled time points, participants were asked to answer Yes or No for each of symptoms/health problems experienced during past 6 months. If a participant answered Yes for a symptom, then impact of that symptom was rated on a 5 point scale, ranged from 1 (least sever impact) to 5 (most severe impact), where higher scores signified more severe impact of symptoms. The total symptom impact score was calculated as the sum of impact of all symptoms. Overall possible range for the total symptom impact score was 0 (no impact) to 60 (extreme impact) for males and 0 (no impact) to 55 (extreme impact) for females, higher scores indicated more severe impact of symptoms on participants' well-being. | Screening, Week 56 | 
| Change From Screening in Mean Total Symptom Impact Scores as Per Survey of Autonomic Symptoms (SAS) at Week 80 | SAS is a participant rated 12 items questionnaire for males and 11 items questionnaire for females. SAS measures autonomic symptoms of neuropathy and their impact on participants' well-being, during the past 6 months. Each item was related to a symptom/health problem. At scheduled time points, participants were asked to answer Yes or No for each of symptoms/health problems experienced during past 6 months. If a participant answered Yes for a symptom, then impact of that symptom was rated on a 5 point scale, ranged from 1 (least sever impact) to 5 (most severe impact), where higher scores signified more severe impact of symptoms. The total symptom impact score was calculated as the sum of impact of all symptoms. Overall possible range for the total symptom impact score was 0 (no impact) to 60 (extreme impact) for males and 0 (no impact) to 55 (extreme impact) for females, higher scores indicated more severe impact of symptoms on participants' well-being. | Screening, Week 80 | 
| Change From Screening in Mean Total Symptom Impact Score as Per Survey of Autonomic Symptoms (SAS) at Early Termination Follow-up Visit 1 | SAS: participant rated 12 items questionnaire for males; 11 items questionnaire for females. SAS measures autonomic symptoms of neuropathy and their impact on participants' well-being, during past 6 months. Each item was related to a symptom/health problem. At scheduled time points, participants answered Yes or No for each of symptoms/health problems experienced during past 6 months. If participant answered Yes for a symptom, then impact of that symptom was rated on 5 point scale (1 [least sever impact] to 5 [most severe impact]); higher scores = more severe impact of symptoms. Total impact score = sum of impact of all symptoms; range for males =0 (no impact) to 60 (extreme impact); females =0 (no impact) to 55 (extreme impact); higher scores = more severe impact of symptoms on participants' well-being. Participants discontinuing from study treatment before Week 56, had early termination follow-up visit 1 at 8 weeks after last dose of tanezumab or placebo matched to tanezumab. | Screening, Early Termination Follow-up Visit 1 (at 8 weeks after last dose of tanezumab or placebo matched to tanezumab) | 
| Change From Screening in Mean Total Symptom Impact Scores as Per Survey of Autonomic Symptoms (SAS) at Early Termination Follow-up Visit 3 | SAS: participant rated 12 items questionnaire for males; 11 items questionnaire for females. SAS measures autonomic symptoms of neuropathy and their impact on participants' well-being, during past 6 months. Each item was related to a symptom/health problem. At scheduled time points, participants answered Yes or No for each of symptoms/health problems experienced during past 6 months. If participant answered Yes for a symptom, then impact of that symptom was rated on 5 point scale (1 [least sever impact] to 5 [most severe impact]); higher scores = more severe impact of symptoms. Total impact score = sum of impact of all symptoms; range for males =0 (no impact) to 60 (extreme impact); females =0 (no impact) to 55 (extreme impact); higher scores = more severe impact of symptoms on participants' well-being. Participants discontinuing from study treatment before Week 56, had early termination follow-up visit 3 at 24 weeks after last dose of tanezumab or placebo matched to tanezumab. | Screening, Early Termination Follow-up Visit 3 (at 24 weeks after last dose of tanezumab or placebo matched to tanezumab) | 
| Number of Participants With Clinically Significant Electrocardiogram (ECG) Assessments | Electrocardiogram assessment included PR, QRS, QT, QT interval corrected using Fridericia's formula (QTcF), QT interval corrected using Bazett's formula (QTcB), RR intervals, and heart rate. Investigator judged clinical significance of electrocardiogram assessment. | Baseline up to Week 16 | 
| Percentage of Participants With Individual Adjudicated Joint Safety Outcome/Event | Percentage of participants with individual joint safety adjudication outcomes: rapidly progressive osteoarthritis (OA) type-1 only, rapidly progressive OA type-2 only, primary osteonecrosis, pathological fracture and subchondral insufficiency fracture is reported. Rapidly progressive (RP) OA type 1 events were those that the adjudication committee considered to have significant loss of joint space width >= 2 millimeter within approximately 1 year without gross structural failure. RP OA type 2 events were those considered to have destruction of bone including limited or total collapse of at least 1 subchondral surface that is not normally present in conventional end-stage osteoarthritis. Subchondral insufficiency fractures are a type of stress fractures which occur below the cartilage on the weight bearing surface of a bone. | Baseline up to Week 80 | 
| Observation Time-Adjusted Event Rate for an Individual Adjudicated Joint Safety Outcome/Event | Individual adjudicated joint safety outcomes/event: rapidly progressive OA (type-1,type-2), primary osteonecrosis, pathological fracture and subchondral insufficiency fracture. Observation time was defined as the start day of first SC study medication until either the (i) date of completion of or withdrawal from study, if a participant did not have the event, or (ii) date of the event (earliest event within each participant in the case of multiple events). Event rate for any individual adjudicated joint safety outcome/event = the number of events per 1000 participant-years at risk. | Baseline (Day 1) up to Week 80 | 
| Percentage of Participants With At Least 1 Total Joint Replacement | Percentage of participants with at least 1 total knee, total hip or total shoulder joint replacement were reported. | Baseline (Day 1) up to Week 80 | 
| Observation Time-Adjusted Event Rate for Total Joint Replacement (TJR) Event | Observation time was defined as the start day of first SC study medication until either the (i) date of completion of or withdrawal from study, if a participant had no TJR, or (ii) date of TJR (earliest TJR within each participant in the case of multiple TJRs). Event rate = number of events per 1000 participant-years at risk. | Baseline (Day 1) up to Week 80 | 
| Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2 | NIS is a standardized instrument used to evaluate signs of peripheral neuropathy in participants. NIS is the sum of scores of 37 items, from both the left and right side of following 4 domains: cranial nerves (5 items), muscle weakness (19 items), reflexes (5 items) and sensation (8 items). Each of 24 items related to cranial nerves and muscle weakness, scored from 0 (normal) to 4 (paralysis); higher scores indicated higher abnormality/impairment. Each of 13 items related to reflexes and sensation, scored as 0 (normal), 1 (decreased) and 2 (absent); higher scores indicated lesser reflexes and sensation. For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits. | Baseline, Week 2 | 
| Change From Baseline in Neuropathy Impairment Score (NIS) at Week 4 | NIS is a standardized instrument used to evaluate signs of peripheral neuropathy in participants. NIS is the sum of scores of 37 items, from both the left and right side of following 4 domains: cranial nerves (5 items), muscle weakness (19 items), reflexes (5 items) and sensation (8 items). Each of 24 items related to cranial nerves and muscle weakness, scored from 0 (normal) to 4 (paralysis); higher scores indicated higher abnormality/impairment. Each of 13 items related to reflexes and sensation, scored as 0 (normal), 1 (decreased) and 2 (absent); higher scores indicated lesser reflexes and sensation. For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits. | Baseline, Week 4 | 
| Change From Baseline in Neuropathy Impairment Score (NIS) at Week 8 | NIS is a standardized instrument used to evaluate signs of peripheral neuropathy in participants. NIS is the sum of scores of 37 items, from both the left and right side of following 4 domains: cranial nerves (5 items), muscle weakness (19 items), reflexes (5 items) and sensation (8 items). Each of 24 items related to cranial nerves and muscle weakness, scored from 0 (normal) to 4 (paralysis); higher scores indicated higher abnormality/impairment. Each of 13 items related to reflexes and sensation, scored as 0 (normal), 1 (decreased) and 2 (absent); higher scores indicated lesser reflexes and sensation. For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits. | Baseline, Week 8 | 
| Change From Baseline in Neuropathy Impairment Score (NIS) at Week 16 | NIS is a standardized instrument used to evaluate signs of peripheral neuropathy in participants. NIS is the sum of scores of 37 items, from both the left and right side of following 4 domains: cranial nerves (5 items), muscle weakness (19 items), reflexes (5 items) and sensation (8 items). Each of 24 items related to cranial nerves and muscle weakness, scored from 0 (normal) to 4 (paralysis); higher scores indicated higher abnormality/impairment. Each of 13 items related to reflexes and sensation, scored as 0 (normal), 1 (decreased) and 2 (absent); higher scores indicated lesser reflexes and sensation. For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits. | Baseline, Week 16 | 
| Change From Baseline in Neuropathy Impairment Score (NIS) at Week 24 | NIS is a standardized instrument used to evaluate signs of peripheral neuropathy in participants. NIS is the sum of scores of 37 items, from both the left and right side of following 4 domains: cranial nerves (5 items), muscle weakness (19 items), reflexes (5 items) and sensation (8 items). Each of 24 items related to cranial nerves and muscle weakness, scored from 0 (normal) to 4 (paralysis); higher scores indicated higher abnormality/impairment. Each of 13 items related to reflexes and sensation, scored as 0 (normal), 1 (decreased) and 2 (absent); higher scores indicated lesser reflexes and sensation. For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits. | Baseline, Week 24 | 
| Change From Baseline in Neuropathy Impairment Score (NIS) at Week 32 | NIS is a standardized instrument used to evaluate signs of peripheral neuropathy in participants. NIS is the sum of scores of 37 items, from both the left and right side of following 4 domains: cranial nerves (5 items), muscle weakness (19 items), reflexes (5 items) and sensation (8 items). Each of 24 items related to cranial nerves and muscle weakness, scored from 0 (normal) to 4 (paralysis); higher scores indicated higher abnormality/impairment. Each of 13 items related to reflexes and sensation, scored as 0 (normal), 1 (decreased) and 2 (absent); higher scores indicated lesser reflexes and sensation. For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits. | Baseline, Week 32 | 
| Change From Baseline in Neuropathy Impairment Score (NIS) at Week 40 | NIS is a standardized instrument used to evaluate signs of peripheral neuropathy in participants. NIS is the sum of scores of 37 items, from both the left and right side of following 4 domains: cranial nerves (5 items), muscle weakness (19 items), reflexes (5 items) and sensation (8 items). Each of 24 items related to cranial nerves and muscle weakness, scored from 0 (normal) to 4 (paralysis); higher scores indicated higher abnormality/impairment. Each of 13 items related to reflexes and sensation, scored as 0 (normal), 1 (decreased) and 2 (absent); higher scores indicated lesser reflexes and sensation. For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits. | Baseline, Week 40 | 
| Change From Baseline in Neuropathy Impairment Score (NIS) at Week 48 | NIS is a standardized instrument used to evaluate signs of peripheral neuropathy in participants. NIS is the sum of scores of 37 items, from both the left and right side of following 4 domains: cranial nerves (5 items), muscle weakness (19 items), reflexes (5 items) and sensation (8 items). Each of 24 items related to cranial nerves and muscle weakness, scored from 0 (normal) to 4 (paralysis); higher scores indicated higher abnormality/impairment. Each of 13 items related to reflexes and sensation, scored as 0 (normal), 1 (decreased) and 2 (absent); higher scores indicated lesser reflexes and sensation. For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits. | Baseline, Week 48 | 
| Change From Baseline in Neuropathy Impairment Score (NIS) at Week 56 | NIS is a standardized instrument used to evaluate signs of peripheral neuropathy in participants. NIS is the sum of scores of 37 items, from both the left and right side of following 4 domains: cranial nerves (5 items), muscle weakness (19 items), reflexes (5 items) and sensation (8 items). Each of 24 items related to cranial nerves and muscle weakness, scored from 0 (normal) to 4 (paralysis); higher scores indicated higher abnormality/impairment. Each of 13 items related to reflexes and sensation, scored as 0 (normal), 1 (decreased) and 2 (absent); higher scores indicated lesser reflexes and sensation. For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits. | Baseline, Week 56 | 
| Change From Baseline in Neuropathy Impairment Score (NIS) at Week 64 | NIS is a standardized instrument used to evaluate signs of peripheral neuropathy in participants. NIS is the sum of scores of 37 items, from both the left and right side of following 4 domains: cranial nerves (5 items), muscle weakness (19 items), reflexes (5 items) and sensation (8 items). Each of 24 items related to cranial nerves and muscle weakness, scored from 0 (normal) to 4 (paralysis); higher scores indicated higher abnormality/impairment. Each of 13 items related to reflexes and sensation, scored as 0 (normal), 1 (decreased) and 2 (absent); higher scores indicated lesser reflexes and sensation. For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits. | Baseline, Week 64 | 
| Change From Baseline in Neuropathy Impairment Score (NIS) at Week 80 | NIS is a standardized instrument used to evaluate signs of peripheral neuropathy in participants. NIS is the sum of scores of 37 items, from both the left and right side of following 4 domains: cranial nerves (5 items), muscle weakness (19 items), reflexes (5 items) and sensation (8 items). Each of 24 items related to cranial nerves and muscle weakness, scored from 0 (normal) to 4 (paralysis); higher scores indicated higher abnormality/impairment. Each of 13 items related to reflexes and sensation, scored as 0 (normal), 1 (decreased) and 2 (absent); higher scores indicated lesser reflexes and sensation. For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits. | Baseline, Week 80 | 
| Largest Change From Baseline in Neuropathy Impairment Score (NIS) to Any Post-baseline Visit | NIS is a standardized instrument used to evaluate signs of peripheral neuropathy in participants. NIS is the sum of scores of 37 items, from both the left and right side of following 4 domains: cranial nerves (5 items), muscle weakness (19 items), reflexes (5 items) and sensation (8 items). Each of 24 items related to cranial nerves and muscle weakness, scored from 0 (normal) to 4 (paralysis); higher scores indicated higher abnormality/impairment. Each of 13 items related to reflexes and sensation, scored as 0 (normal), 1 (decreased) and 2 (absent); higher scores indicated lesser reflexes and sensation. For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits. Largest change from baseline here means worst post- baseline change value (among all change from baseline values). | Baseline to any post-baseline visit (until Week 80) | 
| Number of Participants With Anti Tanezumab Antibodies From Baseline up to Week 80 | Human serum samples were analyzed for the presence or absence of anti-tanezumab antibodies by using a validated analytical method. Number of participants with presence of anti-tanezumab antibodies are reported. | Baseline up to Week 80 | 
| Number of Participants With Abnormal Physical Examination Findings | Physical examination included assessment of general appearance, skin, head, neck, eyes, ears, nose, throat, abdomen, lungs, heart, thyroid, and extremities. Investigator judged abnormality in physical examinations. Only those rows have been reported which had at least 1 participant with abnormality data in any of the reporting arms. | At Screening | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Average Low Back Pain Intensity (LBPI) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Multiple Imputation | Average LBPI was assessed on an 11-point numeric rating scale (NRS). Participants described their average LBPI during the past 24 hours (at each specified/scheduled time-point) on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated worse pain. | Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56 | 
| Change From Baseline in Average Low Back Pain Intensity (LBPI) at Week 64: Observed Data | Average LBPI was assessed on an 11-point NRS. Participants described their average LBPI during the past 24 hours (at each specified/scheduled time-point) on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated worse pain. | Baseline, Week 64 | 
| Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Scores at Weeks 2, 4, 8, 16, 24, 32, 40, 48, and 56: Multiple Imputation | The RMDQ is a self-administered, widely used health status measure index of how well participants with low back pain (LBP) are able to function with regard to daily activities. It measures pain and function, using 24 items describing limitations to everyday life that can be caused by LBP. Participants were asked to check/select only those items out of 24 items, which described them at each specified time point. The total number of items checked in questionnaire was equal to RMDQ total score, overall possible score ranging from 0 (no disability) to 24 (maximum disability), where higher scores indicated greater/more disability. | Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | 
| Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 64: Observed Data | The RMDQ is a self-administered, widely used health status measure index of how well participants with low back pain (LBP) are able to function with regard to daily activities. It measures pain and function, using 24 items describing limitations to everyday life that can be caused by LBP. Participants were asked to check/select only those items out of 24 items, which described them at each specified time point. The total number of items checked in questionnaire was equal to RMDQ total score, overall possible score ranging from 0 (no disability) to 24 (maximum disability), where higher scores indicated greater/more disability. | Baseline, Week 64 | 
| Change From Baseline in the Patient's Global Assessment (PGA) of Low Back Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | PGA of low back pain was assessed by asking a question to participants: Considering all the ways your low back pain affects you, how are you doing today? Participants responded on a 5 point Likert scale ranging from 1 to 5, using interactive response technology (IRT), where 1= very good (asymptomatic and no limitation of normal activities); 2= good (mild symptoms and no limitation of normal activities); 3= fair (moderate symptoms and limitation of some normal activities); 4= poor (severe symptoms and inability to carry out most normal activities); and 5= very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicated worsening of condition. | Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 | 
| Percentage of Participants With Cumulative Percent Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56 | Average LBPI was assessed on an 11-point numeric rating scale (NRS). Participants described their average LBPI during the past 24 hours (at each specified/scheduled time point) on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated worse pain. Percentage of participants with cumulative reduction (as percent change) (greater than [>] 0%; >= 10, 20, 30, 40, 50, 60, 70, 80, 90 and equals to [=] 100%) in average LBPI from baseline to weeks 16, 24 and 56 were reported. Participants (%) might have been counted more than once under various rows. | Baseline, Weeks 16, 24 and 56 | 
| Percentage of Participants With >=30 Percent (%), >=50%, >=70% and >=90% Reduction From Baseline in Weekly Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24, 40 and 56 | Average LBPI was assessed on an 11-point numeric rating scale (NRS). Participants described their average LBPI during the past 24 hours (at each specified/scheduled time point) on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated worse pain. Percentage of participants with reduction in average LBPI of at least (>=) 30%, 50%, 70% and 90% at Weeks 16, 24, 40, and 56 compared to baseline are reported here. Participants (%) might have been counted more than once under various rows. | Baseline, Weeks 16, 24, 40 and 56 | 
| Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Worst Pain at Weeks 2, 4, 8, 16, 24, 40, 56, and 64 | BPI-sf is a self-administered questionnaire to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation at specified time points. BPI-sf scores for worst pain: participants were asked to rate their pain by circling any 1 number from 0 (no pain) to 10 (pain as bad as you can imagine) that best describes their pain at its worst in the last 24 hours; higher scores indicated worse pain. | Baseline, Weeks 2, 4, 8, 16, 24, 40, 56 and 64 | 
| Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Average Pain at Weeks 2, 4, 8, 16, 24, 40, 56, and 64 | BPI-sf is a self-administered questionnaire to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation at specified/scheduled time points. BPI-sf scores for average pain: participants were asked to rate their pain by circling any 1 number from 0 (no pain) to 10 (pain as bad as you can imagine) that best describes their pain on average in the last 24 hours; higher scores indicated worse pain. | Baseline, Weeks 2, 4, 8, 16, 24, 40, 56 and 64 | 
| Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Pain Interference Index at Weeks 2, 4, 8, 16, 24, 40, 56, and 64 | BPI-sf is a self-administered questionnaire to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation at specified/scheduled time points. Pain interference index was calculated as the mean of the 7 BPI-sf pain interference items: pain interference with general activity; mood; walking ability; normal work (outside home and housework); relations with other people; sleep and enjoyment of life. Each of the 7 items had score range from 0 (does not interfere) to 10 (completely interferes), higher scores indicated more interference in daily activities due to pain. Overall score range for pain interference index was 0 (no interference) to 10 (complete interference), higher score = higher interference. | Baseline, Weeks 2, 4, 8, 16, 24, 40, 56 and 64 | 
| Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Pain Interference With General Activity at Weeks 2, 4, 8, 16, 24, 40, 56, and 64 | BPI-sf is a self-administered questionnaire to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation at specified/scheduled time points. BPI-sf scores for pain interference with general activity: participants were asked to circle from any 1 number from 0 (no interference) to 10 (complete interference) that described how, during the past 24 hours, pain has interfered with their general activity; higher scores indicated higher interference. | Baseline, Weeks 2, 4, 8, 16, 24, 40, 56 and 64 | 
| Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Pain Interference With Walking Ability at Weeks 2, 4, 8, 16, 24, 40, 56, and 64 | BPI-sf is a self-administered questionnaire to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation at specified/scheduled time points. BPI-sf scores for pain interference with walking ability: participants were asked to circle from any 1 number from 0 (does not interfere) to 10 (completely interferes) that described how, during the past 24 hours, pain has interfered with their walking ability; higher scores indicated higher interference. | Baseline, Weeks 2, 4, 8, 16, 24, 40, 56 and 64 | 
| Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Pain Interference With Sleep at Weeks 2, 4, 8, 16, 24, 40, 56, and 64 | BPI-sf is a self-administered questionnaire to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation at specified/scheduled time points. BPI-sf scores for pain interference with sleep: participants were asked to circle from any 1 number from 0 (does not interfere) to 10 (completely interferes) that described how, during the past 24 hours, pain has interfered with their sleep; higher scores indicated higher interference. | Baseline, Weeks 2, 4, 8, 16, 24, 40, 56 and 64 | 
| Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Pain Interference With Normal Work at Weeks 2, 4, 8, 16, 24, 40, 56 and 64 | BPI-sf is a self-administered questionnaire to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation at specified/scheduled time points. BPI-sf scores for pain interference with normal work: participants were asked to circle from any 1 number from 0 (does not interfere) to 10 (completely interferes) that described how, during the past 24 hours, pain has interfered with their normal work; higher scores indicated higher interference. | Baseline, Weeks 2, 4, 8, 16, 24, 40, 56 and 64 | 
| Percentage of Participants With Chronic Low Back Pain Responders Index at Weeks 16, 24, 40 and 56 | Chronic low back pain responder index analysis is a composite endpoint of average low back pain intensity (aLBPI) score, PGA of low back pain, and RMDQ total score. aLBPI: evaluate average pain during the past 24 hours, range 0 (no pain) to 10 (worst possible pain), higher scores = higher worse pain. PGA of low back pain: evaluated participants' well-being due to low back pain on day of assessment, range 1 (very good) to 5 (very poor), higher scores = worse condition. RMDQ total score: assessed ability to perform daily activities, range 0 (no disability) to 24 (maximum disability), higher scores = more disability. Participants were successful responders if they had: >=30 percent reduction in aLBPI from baseline to particular week; decrease of >=30 percent in PGA of low back pain from baseline to particular week and no worsening (increase) in RMDQ total score from baseline to particular week. | Weeks 16, 24, 40 and 56 | 
| Percentage of Participants Achieving Change of >=2 Points From Baseline in Patient's Global Assessment (PGA) of Low Back Pain at Weeks 16, 24, 40 and 56 | PGA of low back pain assessed by asking question to participants: Considering all ways your low back pain affects you, how are you doing today? They responded on 5 point Likert scale ranging from 1 to 5, using IRT, where 1= very good (asymptomatic and no limitation of normal activities); 2= good (mild symptoms and no limitation of normal activities); 3= fair (moderate symptoms and limitation of some normal activities); 4= poor (severe symptoms and inability to carry out most normal activities); 5= very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicated worsening of condition. Percentage of participants with positive change of at least 2 points from baseline in PGA of low back pain were reported. | Baseline, Weeks 16, 24, 40 and 56 | 
| European Quality of Life-5 Dimension-5 Levels (EQ-5D-5L): Dimensions Scores at Baseline, Weeks 16 and 56 | EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Higher scores indicated greater levels of problems across each of the five dimensions. | Baseline, Weeks 16 and 56 | 
| European Quality of Life-5 Dimension-5 Levels (EQ-5D-5L): Overall Health Utility Score/ Index Value | EQ-5D health state profile has 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Responses from each of the 5 domains were used to calculate overall health state/a single utility index value. Example: if a participant responded no problems for each 5 dimensions, then health state was coded as 11111 with a predefined single index value to it. Every health state (coded as combination of responses on each of 5 dimensions) had a unique predefined utility index value assigned to it, by EuroQol. Japan value sets (with all possible health states) was used in the study, overall health utility score ranged from -0.111 (minimum score) to 1 (maximum score). Higher (positive) scores = better health state. | Baseline, Weeks 16 and 56 | 
| Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Low Back Pain (WPAI:LBP)- Percent Work Time Missed Due to Chronic Low Back Pain at Weeks 16, 56 and 64 | WPAI:LBP is a participant rated questionnaire that measures the effect of participant's chronic low back pain (CLBP) on general health and symptom severity on work productivity and regular activities. Percentage of work time missed by participants due to CLBP was recorded on a score range of 0 (no impact on work time) to 100 (extreme impact on work time), higher scores indicated greater work time missed and lesser productivity. | Baseline, Weeks 16, 56 and 64 | 
| Change From Baseline in in Work Productivity and Activity Impairment Questionnaire: Low Back Pain (WPAI:LBP)- Percent Impairment While Working Due to Chronic Low Back Pain at Weeks 16, 56 and 64 | WPAI: LBP is a participant rated questionnaire that measures the effect of participant's chronic low back pain (CLBP) on general health and symptom severity on work productivity and regular activities. Percentage of impairment while working due to CLBP was recorded on a score range of 0 (no impairment) to 100 (extreme impairment), higher scores indicated greater impairment while working and lesser productivity. | Baseline, Weeks 16, 56 and 64 | 
| Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Low Back Pain (WPAI:LBP)- Percent Overall Work Impairment Due to Chronic Low Back Pain at Weeks 16, 56 and 64 | WPAI: LBP is a participant rated questionnaire that measures the effect of participant's chronic low back pain (CLBP) on general health and symptom severity on work productivity and regular activities. Percentage of overall work impairment due to CLBP was recorded on a score range of 0 (no impairment) to 100 (extreme impairment), higher scores indicated greater overall work impairment and lesser productivity. | Baseline, Weeks 16, 56 and 64 | 
| Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Low Back Pain (WPAI:LBP)- Percent Activity Impairment Due to Chronic Low Back Pain at Weeks 16, 56 and 64 | WPAI: LBP is a participant rated questionnaire that measures the effect of participant's chronic low back pain (CLBP) on general health and symptom severity on work productivity and regular activities. Percentage of daily activity impairment due to CLBP was recorded on a score range of 0 (no impairment) to 100 (extreme impairment), higher scores indicated greater daily activity impairment and lesser productivity. | Baseline, Weeks 16, 56 and 64 | 
| Number of Participants Who Discontinued Due to Lack of Efficacy | Number of participants who discontinued from study treatment due to lack of efficacy have been reported here. | Baseline up to Week 56 | 
| Time to Discontinuation Due to Lack of Efficacy | Time to discontinuation (in days) due to lack of efficacy was defined as the time interval from the date of first study drug administration up to the date of discontinuation of participant from treatment due to lack of efficacy. Results reported below are contributed only by participants who discontinued due to lack of efficacy. | Baseline up to Week 56 | 
| Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64: Observed Data | In case of inadequate pain relief, acetaminophen/paracetamol tablets up to 3000 mg per day up to 3 days in a week could be taken as rescue medication between Day 1 to Week 64. Number of participants with any use of rescue medication during each specified/scheduled study week were summarized. | Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64 | 
| Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | In case of inadequate pain relief, acetaminophen/paracetamol caplets, tablets, or capsules up to 3000 mg per day up to 3 days in a week could be taken as rescue medication between Day 1 to Week 64. Number of participants with any use of rescue medication during each specified/scheduled study week were summarized. | Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56 | 
| Number of Days of Rescue Medication Use During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64: Observed Data | In case of inadequate pain relief, acetaminophen/paracetamol tablets up to 3000 mg per day up to 3 days in a week could be taken as rescue medication between Day 1 to Week 64. Number of days the participants used the rescue medication during each specified/scheduled study week were summarized. | Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64 | 
| Number of Days of Rescue Medication Use During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: LOCF | In case of inadequate pain relief, acetaminophen/paracetamol caplets, tablets, or capsules up to 3000 mg per day up to 3 days in a week could be taken as rescue medication between Day 1 to Week 64. Number of days the participants used the rescue medication during each specified/scheduled study week were summarized. | Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56 | 
| Amount of Rescue Medication Used in Weeks 2, 4, 8, 12, and 16: Observed Data | In case of inadequate pain relief, acetaminophen/paracetamol tablets up to 3000 mg per day up to 3 days in a week could be taken as rescue medication between Day 1 to Week 64. Amount of rescue medication used during each specified/scheduled study week were summarized. | Weeks 2, 4, 8, 12 and 16 | 
| Amount of Rescue Medication Used in Weeks 2, 4, 8, 12, and 16: LOCF | In case of inadequate pain relief, acetaminophen/paracetamol caplets, tablets, or capsules up to 3000 mg per day up to 3 days in a week could be taken as rescue medication between Day 1 to Week 64. Amount of rescue medication used during each specified/scheduled study week were summarized. | Weeks 2, 4, 8, 12 and 16 | 
| Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain | Low back pain HCRU assessed utilization of healthcare resources usage during last 3 months (last 3 months before Baseline [Day 1] visit, weeks 64 and 80 visit, via IRT). Visits of services directly related to low back pain evaluated were: visits to primary care physician, neurologist, physician assistant or nurse practitioner, pain specialist, orthopedist, physical therapist, chiropractor, alternative medicine or therapy, nutritionist/dietician, radiologist and other practitioner. Participants might have been counted more than once under various rows. Only those rows have been reported which had at least 1 participant evaluable for any reporting arm. | Baseline, Weeks 64 and 80 | 
| Health Care Resource Utilization (HCRU): Number of Participants Visited to the Emergency Room Due to Low Back Pain | Low back pain HCRU assessed utilization of healthcare resources during the last 3 months (last 3 months before Baseline [Day 1] visit, weeks 64 and 80 visit, via IRT). Number of participants who visited the emergency room due to low back pain were evaluated. | Baseline, Weeks 64 and 80 | 
| Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Low Back Pain | Low back pain HCRU assessed utilization of healthcare resources during the last 3 months for baseline, weeks 64 and 80, via IRT. Domain evaluated was number of participants who were hospitalized due to low back pain. | Baseline, Weeks 64 and 80 | 
| Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Low Back Pain | Low back pain HCRU assessed utilization of healthcare resources during the last 3 months (last 3 months before Baseline [Day 1] visit, weeks 64 and 80 visit, via IRT). Number of nights stayed in the hospital due to low back pain were evaluated. | Baseline, Weeks 64 and 80 | 
| Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Low back pain HCRU assessed utilization of healthcare resources during the last 3 months (last 3 months before Baseline [Day 1] visit, weeks 64 and 80 visit, via IRT). Number of participants who used any aids/devices for doing things were evaluated. Aids included walking aid, wheelchair, device or utensil for dress/bathe/eat and any other aids/devices. | Baseline, Weeks 64 and 80 | 
| Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Low Back Pain | Low back pain HCRU assessed utilization of healthcare resources during the last 3 months (last 3 months before Baseline [Day 1] visit, weeks 64 and 80 visit, via IRT). Number of participants who answered as Yes for quitting job due to low back pain, were evaluated. | Baseline, Weeks 64 and 80 | 
| Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Low Back Pain | Low back pain HCRU assessed utilization of healthcare resources during the last 3 months (last 3 months before Baseline [Day 1] visit, weeks 64 and 80 visit, via IRT). Domain evaluated was duration (in years) at each specified time point since quitting job due to low back pain. | Baseline, Weeks 64 and 80 | 
| Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) Scores at Weeks 16 and 56 | TSQM v.II: participant rated 11 items questionnaire. Items 1, 2, 7 to 11 were scored as: 1= extremely dissatisfied, 2= very dissatisfied, 3= dissatisfied, 4= somewhat satisfied, 5= satisfied, 6= very satisfied, 7= extremely satisfied. Items 4 to 6 were scored as: 1= extremely dissatisfied, 2= very dissatisfied, 3= somewhat dissatisfied, 4= slightly dissatisfied, 5= not at all dissatisfied. Item 3 was scored as: 0= No, 1= Yes. Four parameters with respect to study medication were evaluated: Effectiveness = ([Item 1+Item 2] - 2 )/12 *100; Side effects = ([Item 4 + Item 5 + Item 6] - 3)/12 *100, if one item is missing then: ([Sum of two completed items]-2]/8 *100; Convenience = ([Item 7 + Item 8 + Item 9] - 3)/18 *100, if one item is missing then: ([Sum of two completed items]-2)/12 *100; Global satisfaction = ([Item 10+Item 11] - 2 ]/12 *100. Each of the 4 parameters had a scale of 0 (no satisfaction) to 100 (best level of satisfaction), higher score = greater satisfaction. | Weeks 16 and 56 | 
| Number of Participants Responding to Patient Reported Treatment Impact Assessment-Modified (mPRTI) at Weeks 16 and 56 for Willingness to Use Study Drug Again | The mPRTI was a self-administered questionnaire containing 4 items to assess participant satisfaction, previous treatment, preference and willingness to continue using the study medication. To assess participants willingness to use study drug again, participants responded using IRT on 5 point Likert scale ranged from 1-5, where, 1= yes, I would definitely want to use the same drug again, 2= I might want to use the same drug again, 3= I am not sure, 4= I might not want to use the same drug again, 5= no, I definitely would not want to use the same drug again. Higher scores indicated lesser willingness to use the study drug. | Weeks 16 and 56 | 
| Number of Participants Responding to Patient Reported Treatment Impact Assessment-Modified (mPRTI) at Weeks 16 and 56 for Preference of Study Drug Versus Prior Treatment | The mPRTI was a self-administered questionnaire containing 4 items to assess participant satisfaction, previous treatment, preference and willingness to continue using the study medication. To assess preference to continue using study drug versus previous treatment, participants responded using IRT on 5 point Likert scale from 1-5, where, 1= yes, I definitely prefer drug that I am receiving now, 2= I have a slight preference for drug that I am receiving now, 3= I have no preference either way, 4= I have a slight preference for my previous treatment, 5= No, I definitely prefer my previous treatment. Higher scores indicate lesser preference to use study drug. | Weeks 16 and 56 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic low back pain, Chronic pain