Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Pfizer |
---|---|
Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00652808 |
This study was performed to demonstrate that treatment with valdecoxib 10 mg daily (QD) was at least as effective as with naproxen 500 mg twice daily (BID), a standard non-steroidal anti-inflammatory drug (NSAID), when taken for 6 weeks in Korean subjects with symptomatic osteoarthritis (OA) of the knee. Secondary objectives were to assess the overall safety and tolerability of valdecoxib 10 mg QD taken for 6 weeks in Korean subjects with symptomatic OA of the knee.
Condition | Intervention | Phase |
---|---|---|
Osteoarthritis Knee |
Drug: valdecoxib Drug: naproxen |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Double-Blind, Double Dummy, Randomized Comparison Study to Evaluate the Efficacy and Safety of Valdecoxib 10 mg QD and Naproxen 500 mg BID in Treating the Signs and Symptoms of Osteoarthritis of the Knee |
Enrollment: | 265 |
Study Start Date: | May 2004 |
Study Completion Date: | September 2004 |
Arms | Assigned Interventions |
---|---|
Arm 1: Active Comparator |
Drug: valdecoxib
valdecoxib 10 mg tablet by mouth once daily for 6 weeks
|
Arm 2: Active Comparator |
Drug: naproxen
naproxen 500 mg capsule by mouth twice daily for 6 weeks
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Korea, Republic of | |
Pfizer Investigational Site | |
Seoul, Korea, Republic of, 137-701 | |
Pfizer Investigational Site | |
Seoul, Korea, Republic of, 110-744 | |
Pfizer Investigational Site | |
Seoul, Korea, Republic of, 138-736 | |
Pfizer Investigational Site | |
Anyang, Korea, Republic of, 431-070 | |
Pfizer Investigational Site | |
Incheon, Korea, Republic of, 405-760 | |
Pfizer Investigational Site | |
Pusan, Korea, Republic of, 602-739 | |
Pfizer Investigational Site | |
Gwangju, Korea, Republic of, 501-757 | |
Pfizer Investigational Site | |
Seoul, Korea, Republic of, 152-703 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A3471045 |
Study First Received: | April 1, 2008 |
Last Updated: | April 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00652808 |
Health Authority: | Unkown: Obtaining information and will provide once confirmed. |
knee, OA patients |
Signs and Symptoms Osteoarthritis, Knee Naproxen Musculoskeletal Diseases Osteoarthritis |
Joint Diseases Arthritis Rheumatic Diseases Valdecoxib |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Gout Suppressants 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 |