The purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of osteoarthritis of the knee...
Date First Received: September 22, 2004
Last Updated: July 5, 2006
Verified by: Merck, September 2005
Clinical Trial Phase: Phase 3 | Start Date: May 2003
Overall Status: Completed
Estimated Enrollment: 375
Brief Summary
Official Title: “A Randomized, Placebo-Controlled, Parallel-Group, Double -Blind Study to Evaluate the Safety and Efficacy of Rofecoxib 12.5 Mg and Celecoxib 200 Mg in Patients With Osteoarthritis of the Knee”
Condition Keyword(s):
Intervention(s):
The purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of osteoarthritis of the knee.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Detailed Clinical Trial Description
The duration of treatment is 6 weeks.
Intervention(s) in this Clinical Trial
- Drug: MK0966, rofecoxib
- Drug: Comparator: celecoxib, placebo
Outcome Measures for this Clinical Trial
Primary Measures
- Osteoarthritis (OA) of the knee as measured by Patient Global Assessment of Response to Therapy (PGART) and WOMAC VA 3.0 over 6 weeks of treatment.
Secondary Measures
- OA of the knee as measured by PGART over 6 wks of treatment.
- WOMAC Question #1 over 6 wks of treatment.
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Osteoarthritis of the knee which requires treatment with medication for pain relief
Exclusion Criteria:
- Any known allergy to the study drugs
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 40 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Merck
Related Publications
References
Birbara C, Ruoff G, Sheldon E, Valenzuela C, Rodgers A, Petruschke RA, Chang DJ, Tershakovec AM. Efficacy and safety of rofecoxib 12.5 mg and celecoxib 200 mg in two similarly designed osteoarthritis studies. Curr Med Res Opin. 2006 Jan;22(1):199-210.
Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00092365
Study ID Number: 2004_071
ClinicalTrials.gov Identifier: NCT00092365
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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