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Clinical Trials/NCT00092352
NCT00092352
Completed
Phase 3

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

Merck Sharp & Dohme LLC0 sites395 target enrollmentApril 29, 2003
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ConditionsOsteoarthritis
DrugsMK0966, rofecoxibComparator: celecoxib, placebo

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Osteoarthritis
Sponsor
Merck Sharp & Dohme LLC
Enrollment
395
Primary Endpoint
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.
Status
Completed
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

The purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of osteoarthritis of the knee.

Detailed Description

The duration of treatment is 6 weeks.

Registry
clinicaltrials.gov
Start Date
April 29, 2003
End Date
December 1, 2003
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Osteoarthritis of the knee which requires treatment with medication for pain relief

Exclusion Criteria

  • •Any known allergy to the study drug

Outcomes

Primary Outcomes

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 Outcomes

  • WOMAC Question #1 over 6 wks of treatment.
  • OA of the knee as measured by PGART over 6 wks of treatment.

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