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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00092365
Recruitment Status : Completed
First Posted : September 27, 2004
Last Update Posted : May 9, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: MK0966, rofecoxib Drug: Comparator: celecoxib, placebo Phase 3

Detailed Description:
The duration of treatment is 6 weeks.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 413 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Actual Study Start Date : April 1, 2003
Primary Completion Date : November 1, 2003
Study Completion Date : November 1, 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
Drug Information available for: Celecoxib
U.S. FDA Resources

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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00092365

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

Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00092365     History of Changes
Other Study ID Numbers: 0966-220
First Posted: September 27, 2004    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017

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