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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00640627 |
To compare the safety and efficacy of celecoxib versus placebo in the treatment of patients with knee osteoarthritis who were unresponsive to treatment with prescription strength naproxen and ibuprofen or who could not tolerate prescription strength naproxen and ibuprofen
Condition | Intervention | Phase |
---|---|---|
Osteoarthritis, Knee |
Drug: Celecoxib Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind, Placebo-Controlled Study of the Efficacy and Tolerability of Once Daily Celebrex® (Celecoxib) vs. Placebo in the Treatment of Subjects With Osteoarthritis of the Knee Non-Responsive to Naproxen and Ibuprofen |
Enrollment: | 380 |
Study Start Date: | December 2003 |
Study Completion Date: | September 2004 |
Arms | Assigned Interventions |
---|---|
A: Experimental |
Drug: Celecoxib
200 mg oral capsule once daily for 6 weeks
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B: Placebo Comparator |
Drug: Placebo
Matched oral placebo for 6 weeks
|
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A3191069 |
Study First Received: | March 17, 2008 |
Last Updated: | April 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00640627 |
Health Authority: | United States: Food and Drug Administration |
Osteoarthritis, Knee Ibuprofen Naproxen Celecoxib Musculoskeletal Diseases |
Osteoarthritis Joint Diseases Arthritis Rheumatic Diseases |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Cyclooxygenase Inhibitors Physiological Effects of Drugs Enzyme Inhibitors Pharmacologic Actions Analgesics, Non-Narcotic |
Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |