A Phase 3 Study of Tanezumab for Chronic Low Back Pain

Completed · Phase 3 · Has a placebo group

Conditions studied: Low Back Pain

In brief

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.

Key facts

Study ID

NCT02528253

Run by

Pfizer

People needed

1832

Starts

2015-08-18

Expected to finish

2018-12-20

Last updated by the study team

2020-02-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• -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.

Where it is running

• Cahaba Research — Birmingham, Alabama, United States
• Alabama Clinical Research, LLC — Mobile, Alabama, United States
• Alabama Orthopaedic Clinic, P.C. — Mobile, Alabama, United States
• Coastal Clinical Research — Mobile, Alabama, United States
• Horizon Research Partners, LLC — Mobile, Alabama, United States
• The Center for Clinical Trials, Inc. — Saraland, Alabama, United States
• Ferguson Family Medicine — Mesa, Arizona, United States
• The Pain Center of Arizona — Phoenix, Arizona, United States
• Arizona Research Center — Phoenix, Arizona, United States
• Valley Pain Consultants — Scottsdale, Arizona, United States
• KLR Business Group dba Arkansas Clinical Research — Little Rock, Arkansas, United States
• Lynn Institute of the Ozarks — Little Rock, Arkansas, United States
• Primary Care of Arkansas, P.A. — Little Rock, Arkansas, United States
• Anaheim Clinical Trials, LLC — Anaheim, California, United States
• Core Healthcare Group — Cerritos, California, United States
• eStudySite — Chula Vista, California, United States
• Triwest Research Associates, LLC — El Cajon, California, United States
• Research Center of Fresno, Inc. — Fresno, California, United States
• Neuro-Pain Medical Center — Fresno, California, United States
• Valley Research-Trials — Fresno, California, United States
• Collaborative Neuroscience Network, LLC. — Garden Grove, California, United States
• eStudySite — La Mesa, California, United States
• Collaborative Neuroscience Network, LLC. — Long Beach, California, United States
• University of Southern California — Los Angeles, California, United States
• Central Alabama Research — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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