Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Pfizer |
---|---|
Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00638807 |
To compare the efficacy and safety of celecoxib versus placebo for the treatment of knee osteoarthritis (OA) in patients who were unresponsive to prescription strength naproxen and ibuprofen or who could not tolerate prescription strength naproxen and ibuprofen
Condition | Intervention | Phase |
---|---|---|
Osteoarthritis, Knee |
Drug: Celecoxib Other: 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: | 388 |
Study Start Date: | December 2003 |
Study Completion Date: | July 2004 |
Arms | Assigned Interventions |
---|---|
A: Experimental |
Drug: Celecoxib
200 mg oral capsule once daily with morning meal for 6 weeks
|
B: Placebo Comparator |
Other: 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:
Inclusion criteria:
Exclusion Criteria:
Exclusion criteria:
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A3191082 |
Study First Received: | March 12, 2008 |
Last Updated: | March 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00638807 |
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 |