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Sponsored by: |
Pfizer |
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 |
MedlinePlus related topics: | Osteoarthritis |
ChemIDplus related topics: | Ibuprofen Dexibuprofen Celecoxib 4-(5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)benzenesulfonamide Naproxen sodium Naproxen |
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
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Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
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Show 30 Study Locations |
Pfizer |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
To obtain contact information for a study center near you, click here. 
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Link to ClinicalStudyResults.org posting: 
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Responsible Party: | Pfizer, Inc ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A3191069 |
First Received: | March 17, 2008 |
Last Updated: | April 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00640627 |
Health Authority: | United States: Food and Drug Administration |
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