A Study of Two Approved Drugs in Patients With Osteoarthritis (0966-219)

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: December 1, 2003

Detailed Description

The duration of treatment is 6 weeks.

Interventions

  • Drug: MK0966, rofecoxib
  • Drug: Comparator: celecoxib, placebo

Clinical Trial Outcome Measures

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.

Participating 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 drug

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Merck Sharp & Dohme LLC
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Monitor, Study Director, Merck Sharp & Dohme LLC

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. doi: 10.1185/030079906X80242.

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