NCT00876187CompletedPhase 2
A RANDOMIZED, DOUBLE-BLIND, MULTI-DOSE, ACTIVE- AND PLACEBO-CONTROLLED, MULTI-CENTER, PARALLEL GROUP STUDY OF THE ANALGESIC EFFECTS OF TANEZUMAB IN ADULT PATIENTS WITH CHRONIC LOW BACK PAIN
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 1,359
- Locations
- 129
- Primary Endpoint
- Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 16: Baseline Observation Carried Forward (BOCF)
Study Overview
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of multiple doses of tanezumab administered every 8 weeks in treating chronic low back pain. Tanezumab is a monoclonal antibody directed against human nerve growth factor.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Present with duration of low back pain of ≥3 months requiring regular use of analgesic medication (>4 days per week for the past month). Analgesic medication may consist of NSAIDs, selective COX-2 inhibitors, immediate release opioids, or combinations, with certain protocol-defined limitations.
- •Primary location of low back pain must be between the 12th thoracic vertebra and the lower gluteal folds, with or without radiation into the posterior thigh
- •Must meet criteria for pain severity and global assessment of low back pain at Screening and Baseline visits
- •Female patients of child-bearing potential (and male patients with female partners who are of child-bearing potential) must use 2 methods of contraception throughout the study
- •Patients must be willing to discontinue all pain medications for chronic low back pain except rescue medication and not use prohibited pain medications throughout the duration of the study
Exclusion Criteria
- •History of lumbosacral radiculopathy within the past 2 years.
- •Back pain due to visceral disorder (eg, endometriosis).
- •Back pain due to major trauma or osteoporotic compression fracture in the past 6 months.
- •History of rheumatoid arthritis, seronegative spondyloarthropathy, Paget's disease of spine, pelvis or femur; fibromyalgia; tumors or infections of the spinal cord.
- •Surgical intervention during the past 6 months for the treatment of low back pain or plans for surgical intervention during the course of the study.
- •Current or pending worker's compensation, litigation, disability, or any other monetary settlement regarding his/her CLBP or any other pain condition, or any closed claim within the past 5 years.
- •Use of any analgesic or muscle relaxant within 48 hours prior to the five days before Baseline
- •Patients receiving only acetaminophen, gabapentin or pregabalin to manage their chronic low back pain.
- •Patients taking >325 mg/day of aspirin.
- •Use of any antidepressants with the exception of stable treatment with selective serotonin reuptake inhibitors (SSRIs).
- •Use of any sedatives/hypnotics, anxiolytics, tranquilizers, or benzodiazepines unless daily dose has been stable and will remain unchanged throughout the study period.
- •Systemic corticosteroid therapy within 30 days (inhaled and topical corticosteroids are permitted).
- •Local or epidural injection of corticosteroids, as well as injections of corticosteroids in the back within 3 months.
- •Botulinum toxin (Botox®) injection for chronic low back pain within 4 months.
- •Requirement for new, concomitant physiotherapy including, but not limited to, transdermal electroneural stimulation (TENS), massage or spinal manipulation for the duration of the study period.
- •Active or suspected esophageal, gastric, pyloric channel, or duodenal ulceration within 3 months, or any history of gastrointestinal bleeding.
- •Current use of lithium or anticoagulant agents.
- •Known hypersensitivity or intolerance to NSAIDs; history of asthma, urticaria, or allergic type reactions after taking aspirin or NSAIDs.
- •Inflammatory bowel disease, a chronic or acute renal or hepatic disorder, a significant coagulation defect, or other condition that might preclude the use of an NSAID.
- •History of intolerance to acetaminophen or paracetamol or any of its excipients.
- •History of known alcohol, analgesic or narcotic abuse within 2 years.
- •Presence of drugs of abuse (including prescription medications without a valid prescription), other illegal drugs or marijuana in the urine toxicology screen obtained at Screening.
- •History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG fusion protein.
- •Use of biologics other than study medication, including any live vaccines, within 3 months, or use during the study (intranasal Flumist® vaccine is an exception).
- •Signs and symptoms of clinically significant cardiac disease.
- •Diagnosis of a transient ischemic attack within the 6 months, or residual deficits from stroke that would preclude completion of required study activities.
- •History of cancer within 5 years.
- •Use of any investigational medication within 30 days (3 months for investigational biologics).
- •Expected to undergo a therapeutic procedure or to use any analgesic other than those specified in the protocol throughout the study period.
- •Previous exposure to exogenous NGF or to an anti NGF antibody.
- •Screening laboratory results and blood pressure within specified limits.
- •Positive Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV) tests at screening.
- •History, diagnosis, or signs and symptoms of clinically significant neurological disease.
- •History, diagnosis, signs or symptoms of any clinically significant psychiatric disorder.
- •Hospital admission for depression or suicide attempt within 5 years or active, severe major depression at Screening.
- •Likelihood of being non compliant with study procedures.
Arms & Interventions
Tanezumab 20 mg IV
Experimental
Intervention: Placebo for naproxen (Drug)
Naproxen
Active Comparator
Intervention: Naproxen (Drug)
Tanezumab 20 mg IV
Experimental
Intervention: Tanezumab 20 mg IV (Biological)
Tanezumab 10 mg IV
Experimental
Intervention: Tanezumab 10 mg IV (Biological)
Tanezumab 10 mg IV
Experimental
Intervention: Placebo for naproxen (Drug)
Tanezumab 5 mg IV
Experimental
Intervention: Tanezumab 5 mg IV (Biological)
Tanezumab 5 mg IV
Experimental
Intervention: Placebo for naproxen (Drug)
Naproxen
Active Comparator
Intervention: Placebo for tanezumab (Biological)
Placebo
Placebo Comparator
Intervention: Placebo for tanezumab (Biological)
Placebo
Placebo Comparator
Intervention: Placebo for naproxen (Drug)
Outcomes
Primary Outcomes
Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 16: Baseline Observation Carried Forward (BOCF)
Time Frame: Baseline, Week 16
Daily average back pain was assessed on an 11-point numeric rating scale (NRS) captured through an interactive voice response system (IVRS). The participant described the chronic low back pain (CLBP) during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain). Baseline value was calculated as mean of the scores over 5 days prior to randomization (initial pain assessment period). Post-baseline value was calculated as mean of the scores over the 7-day period prior to and including the post-baseline visit. Overall possible score range for daily average LBPI at specified visit was 0= no pain to 10= worst possible pain, where higher scores indicated higher pain intensity.
Secondary Outcomes
- Duration of Rescue Medication Use(Week 2, 4, 8, 12, 16)
- Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)(Baseline, Week 2, 4, 8, 12, 16)
- Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)(Baseline, Week 2, 4, 8, 12, 16)
- Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF(Baseline, Week 2, 4, 8, 12, 16)
- Number of Participants With Chronic Low Back Pain (CLBP) Responder Index: Baseline Observation Carried Forward (BOCF)(Week 2, 4, 8, 12, 16)
- Amount of Rescue Medication Taken(Week 2, 4, 8, 12, 16)
- Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF)(Baseline, Week 2, 4, 8, 12, 16)
- Total Nerve Growth Factor (NGF) Concentration(Baseline (pre-dose and 1 hour [hr] post-dose); Any time point at Week 4 Visit; Week 8 (pre-dose and 1 hr post-dose); Any time point at Week 16 Visit, at Week 24 Visit)
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(Baseline up to Week 24)
- Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF)(Baseline, Week 16)
- Time to Discontinuation Due to Lack of Efficacy(Baseline up to Week 16)
- Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)(Baseline, Week 2, 4, 8, 12, 16)
- Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)(Baseline, Week 2, 4, 8, 12)
- Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16(Baseline, Week 8, 16)
- Percentage of Participants Who Used Rescue Medications(Week 2, 4, 8, 12, 16)
- Change From Baseline Neuropathy Impairment Score (NIS) at Week 8, 16 and 24(Baseline, Week 8, 16, 24)
- Number of Participants Who Developed Anti-Tanezumab Antibodies(Baseline (Day 1), Week 8, 16, 24)
- Plasma Concentration of Tanezumab(Baseline (pre-dose and 1 hour [hr] post-dose); Any time point at Week 4 Visit; Week 8 (pre-dose and 1 hr post-dose); Any time point at Week 16 Visit, at Week 24 Visit)
Investigators
Study Sites (129)
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