A Study of Tanezumab in Adults With Chronic Low Back Pain
CompletedPhase 2NCT00876187
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 details
- Official title
- 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
- Biological: Tanezumab 20 mg IV
- Drug: Placebo for naproxen
- Biological: Tanezumab 10 mg IV
- Drug: Placebo for naproxen
- Biological: Tanezumab 5 mg IV
- Drug: Placebo for naproxen
- Biological: Placebo for tanezumab
- Drug: Naproxen
- Biological: Placebo for tanezumab
- Drug: Placebo for naproxen
- Sponsor
- Pfizer
- Start date
- 2009-06-15
- Primary completion
- 2010-06-16
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 135
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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®) injecti…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00876187