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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00830063 |
Test the efficacy and safety of 2 doses of tanezumab compared with naproxen and placebo in patients with osteoarthritis.
Condition | Intervention |
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Arthritis Osteoarthritis |
Biological: tanezumab 10 mg Biological: tanezumab 5 mg Drug: naproxen Other: placebo |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 3 Randomized, Double Blind Placebo And Naproxen Controlled Multicenter Study Of The Analgesic Efficacy And Safety Of Tanezumab In Patients With Osteoarthritis Of The Knee |
Estimated Enrollment: | 800 |
Study Start Date: | May 2009 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Biological: tanezumab 10 mg
tanezumab 10 mg one dose at weeks 0 and 8
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2: Experimental |
Biological: tanezumab 5 mg
tanezumab 5 mg one dose at weeks 0 and 8
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3: Active Comparator |
Drug: naproxen
naproxen 1000 mg daily for 16 weeks
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4: Placebo Comparator |
Other: placebo
placebo to match tanezumab and naproxen dosing
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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: | A4091015 |
Study First Received: | January 23, 2009 |
Last Updated: | May 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00830063 History of Changes |
Health Authority: | United States: Food and Drug Administration |
monoclonal antibody, RN624, PF-04383119, nerve growth factor, anti-nerve growth factor, OA, pain |
Anti-Inflammatory Agents Naproxen Osteoarthritis Joint Diseases Cyclooxygenase Inhibitors Pain Rheumatic Diseases Antibodies, Monoclonal Osteoarthritis, Knee Antibodies |
Musculoskeletal Diseases Analgesics, Non-Narcotic Arthritis Mitogens Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Immunoglobulins |
Anti-Inflammatory Agents Naproxen Molecular Mechanisms of Pharmacological Action Osteoarthritis Joint Diseases Cyclooxygenase Inhibitors Physiological Effects of Drugs Enzyme Inhibitors Rheumatic Diseases Gout Suppressants Pharmacologic Actions |
Osteoarthritis, Knee Musculoskeletal Diseases Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Arthritis Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |