A Study of MK0663 and an Approved Drug in the Treatment of Osteoarthritis (0663-076)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00092768
First received: September 23, 2004
Last updated: May 21, 2013
Last verified: May 2013
  Purpose

The purpose of this study is to compare the safety and effectiveness of an investigational drug and an approved drug in the treatment of osteoarthritis of the knee and hip.


Condition Intervention Phase
Osteoarthritis
Drug: MK0663, etoricoxib
Drug: Comparator: celecoxib
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 26-Week, Randomized, Placebo- and Active-Comparator-Controlled, Parallel-Group, Double-Blind, 2-Part Study to Assess the Safety and Efficacy of Etoricoxib 30 mg Versus Celecoxib 200 mg in Patients With Osteoarthritis (Study 1)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Osteoarthritis of the knee & hip as assessed by WOMAC VA 3.0 pain and physical function subscales, Patient/Investigator assessments of disease and response to therapy over 12 weeks of treatment.

Secondary Outcome Measures:
  • Maintenance of clinical efficacy as assessed by WOMAC subscales and Patient assessments over a 26-wks of treatment. Safety / tolerability over a 12-wk and 6-mo treatment period.

Enrollment: 500
Study Start Date: March 2004
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
Detailed Description:

The duration of treatment is 26 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 or hip which requires treatment with a medication to obtain pain relief

Exclusion Criteria:

  • Any known allergy to the study drugs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00092768

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

Publications:
Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00092768     History of Changes
Other Study ID Numbers: 2004_057, MK0663-076
Study First Received: September 23, 2004
Last Updated: May 21, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Arcoxia

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Celecoxib
Etoricoxib
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 April 14, 2014