A Phase 3 Study of Tanezumab for Chronic Low Back Pain
CompletedPhase 3NCT02528253
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Brief summary (from the registry)
This study will investigate the efficacy and safety of tanezumab 5 mg and 10 mg administered by subcutaneous injection seven times at 8 week intervals (56 weeks). The primary objective of this study is to evaluate the effectiveness of tanezumab 10 mg and 5 mg compared to placebo for the treatment of chronic low back pain. Secondary objectives are to evaluate the long-term safety and effectiveness of tanezumab 10 mg and 5 mg compared to placebo for the treatment of chronic low back pain. In addition, the study will evaluate the effectiveness and long term safety profile of tanezumab treatment for chronic low back pain compared to tramadol Prolonged Release (PR), a medication commonly utilized for the treatment of chronic low back pain.
Study details
- Official title
- A Phase 3, Randomized, Double Blind, Placebo And Active-Controlled, Multicenter, Parallel-Group Study Of The Analgesic Efficacy And Safety Of Tanezumab In Adult Subjects With Chronic Low Back Pain
- Conditions
- Interventions
- Biological: Placebo to Week 16
- tanezumab 5mg SC
- Biological: Placebo to Week 16, tanezumab 10 mg SC
- Biological: Tanezumab 5 mg SC
- Biological: Tanezumab 10 mg SC
- Biological: Tramadol PR oral
- Sponsor
- Pfizer
- Collaborators
- Eli Lilly and Company
- Start date
- 2015-08-18
- Primary completion
- 2017-10-17
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- Canada, Denmark, France, Hungary, Japan, South Korea, Spain, Sweden, United States
- Total sites listed
- 262
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: -Chronic low back pain ≥3 months in duration, Quebec Task Force in Spinal Disorders class 1 or 2, with documented history of previous inadequate treatment response to at least 3 different categories of agents commonly used and generally considered effective for the treatment of chronic low back pain. Exclusion Criteria: --Diagnosis of osteoarthritis of the knee or hip as defined by the American College of Rheumatology (ACR) 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; * History or radiographic evidence of other diseases that could confound efficacy or safety assessments (e.g., 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. * Signs and symptoms of clinically significant cardiac disease within 6 months of the study (e.g., unstable angina, myocardial infarction, resting bradycardia, poorly controlled or untreated hypertension) as defined in the protocol or subjects with any other cardiovascular illness that in the opinion of the Investigator would render a subject unsuitable to participate in the study * History, diagnosis, or signs and symptoms of clinically significant neurological disease (e.g., transient ischemic attack, stroke, peripheral or autonomic neuropathy) as specified in the protocol * Subjects with evidence or symptoms consistent with autonomic dysfunction (e.g., orthostatic hypotension and/or autonomic symptoms) as defined in the protocol.
Canadian sites (5)
| Facility | City | Province |
|---|---|---|
| SKDS Research Inc. | Newmarket | Ontario |
| London Road Diagnostic Clinic & Medical Centre | Sarnia | Ontario |
| Centre de recherche Saint-Louis | Québec | Quebec |
| G.R.M.O. (Groupe de recherche en maladies osseuses) Inc. | Québec | Quebec |
| Diex Research Sherbrooke Inc. | Sherbrooke | Quebec |
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02528253