A Phase 3 Study of Tanezumab for Chronic Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Intervention: Placebo to Week 16; tanezumab 5mg SC; Placebo to Week 16, tanezumab 10 mg SC; Tanezumab 5 mg SC; Tanezumab 10 mg SC; Tramadol PR oral
Intervention description: Placebo SC injection every 8 weeks for 2 injections followed by tanezumab 5 mg injection every 8 weeks for 5 injections; Placebo SC injection every 8 weeks for 2 injections, followed by tanezumab 10 mg SC injection for 5 injections; Tanezumab 5 mg SC; Tanezumab 10 mg SC; Tramadol PR oral
Intervention MeSH terms: Tramadol; Tanezumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1832.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic low back pain; Chronic pain

Summary:

      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.
    

Eligibility criteria:

        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.