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

This study has been completed.
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
First received: September 22, 2004
Last updated: March 15, 2011
Last verified: March 2011

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

Condition Intervention Phase
Drug: MK0966, rofecoxib
Drug: Comparator: celecoxib, placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

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

Estimated Enrollment: 375
Study Start Date: April 2003
Study Completion Date: November 2003
Detailed Description:

The duration of treatment is 6 weeks.


Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Any known allergy to the study drugs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00092365

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00092365     History of Changes
Other Study ID Numbers: 2004_071, MK0966-220
Study First Received: September 22, 2004
Last Updated: March 15, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 21, 2014