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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00092365
First received: September 22, 2004
Last updated: April 23, 2014
Last verified: April 2014
  Purpose

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
Osteoarthritis
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.

Enrollment: 413
Study Start Date: April 2003
Study Completion Date: November 2003
Primary Completion Date: November 2003 (Final data collection date for primary outcome measure)
Detailed Description:

The duration of treatment is 6 weeks.

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00092365

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

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00092365     History of Changes
Other Study ID Numbers: 0966-220, 2004_071
Study First Received: September 22, 2004
Last Updated: April 23, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Celecoxib
Rofecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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 July 23, 2014