A study to compare pre-operative administration of rofecoxib versus post-operative administration of diclofenac or rofecoxib, respectively, in the treatment of post-operative pain after total knee joint replacement in patients with osteoarthritis of the knee...
Date First Received: August 30, 2005
Last Updated: November 30, 2006
Verified by: Merck, November 2006
Clinical Trial Phase: Phase 4 | Start Date: January 2004
Overall Status: Terminated
Estimated Enrollment: 150
Brief Summary
Official Title: “A Study to Compare Pre-Operative Administration of Rofecoxib Vs Post-Operative Administration of Diclofenac or Rofecoxib in the Treatment of Post-Operative Pain After Total Knee Joint Replacement in Patients With Osteoarthritis of the Knee.”
Condition Keyword(s):
Intervention(s):
A study to compare pre-operative administration of rofecoxib versus post-operative administration of diclofenac or rofecoxib, respectively, in the treatment of post-operative pain after total knee joint replacement in patients with osteoarthritis of the knee.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: MK0966; rofecoxib
- Drug: Comparator: diclofenac 2x 75 mg
Outcome Measures for this Clinical Trial
Primary Measures
- Quantity of patient controlled
- Post-operative morphine administration
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Males or females at least 18 years of age who have osteoarthritis of the knee and have undergone total knee joint replacement.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Merck
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Merck
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00140920
Study ID Number: 2005_054
ClinicalTrials.gov Identifier: NCT00140920
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Clinical Trials Authorship and Review
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