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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00876187 |
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.
Condition | Intervention | Phase |
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Low Back Pain |
Biological: Tanezumab 20 mg IV Drug: Placebo for naproxen Biological: Tanezumab 10 mg IV Biological: Tanezumab 5 mg IV Biological: Placebo for tanezumab Drug: Naproxen |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 1000 |
Study Start Date: | June 2009 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Tanezumab 20 mg IV: Experimental |
Biological: Tanezumab 20 mg IV
2 IV administrations of tanezumab 20 mg at an 8 week interval
Drug: Placebo for naproxen
Oral placebo for naproxen twice a day for 16 weeks
|
Tanezumab 10 mg IV: Experimental |
Biological: Tanezumab 10 mg IV
2 IV administrations of tanezumab 10 mg at an 8 week interval
Drug: Placebo for naproxen
Oral placebo for naproxen twice a day for 16 weeks
|
Tanezumab 5 mg IV: Experimental |
Biological: Tanezumab 5 mg IV
2 IV administrations of tanezumab 5 mg at an 8 week interval
Drug: Placebo for naproxen
Oral placebo for naproxen twice a day for 16 weeks
|
Naproxen: Active Comparator |
Biological: Placebo for tanezumab
2 IV administrations of placebo for tanezumab at an 8 week interval
Drug: Naproxen
Oral naproxen 500 mg twice a day for 16 weeks
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Placebo: Placebo Comparator |
Biological: Placebo for tanezumab
2 IV administrations of placebo for tanezumab at an 8 week interval
Drug: Placebo for naproxen
Oral placebo for naproxen twice a day for 16 weeks
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A4091012 |
Study First Received: | April 3, 2009 |
Last Updated: | May 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00876187 History of Changes |
Health Authority: | United States: Food and Drug Administration |
randomized controlled trial, monoclonal antibody, nerve growth factor, naproxen |
Anti-Inflammatory Agents Naproxen Cyclooxygenase Inhibitors Low Back Pain Pain Back Pain Antibodies, Monoclonal Signs and Symptoms Antibodies |
Analgesics, Non-Narcotic Neurologic Manifestations Mitogens Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Immunoglobulins |
Anti-Inflammatory Agents Naproxen Molecular Mechanisms of Pharmacological Action Cyclooxygenase Inhibitors Nervous System Diseases Physiological Effects of Drugs Low Back Pain Enzyme Inhibitors Pain Gout Suppressants Back Pain |
Pharmacologic Actions Signs and Symptoms Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Neurologic Manifestations Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |