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NCT00092365 Clinical Trial

A Study of Two Approved Drugs in Patients With Osteoarthritis (0966-220)(COMPLETED)

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00092365
Other study ID # 0966-220
Secondary ID 2004_071
Status Completed
Phase Phase 3
First received September 22, 2004
Last updated May 5, 2017
Start date April 1, 2003
Est. completion date November 1, 2003

Study information
Verified date May 2017
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

The duration of treatment is 6 weeks.

Recruitment information / eligibility
Status Completed
Enrollment 413
Est. completion date November 1, 2003
Est. primary completion date November 1, 2003
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Any known allergy to the study drugs

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• MK0966, rofecoxib

• Comparator: celecoxib, placebo

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 OA of the knee as measured by PGART over 6 wks of treatment.
Secondary WOMAC Question #1 over 6 wks of treatment.
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