A Study of Rofecoxib in the Treatment of Post-Operative Pain After Total Knee Joint Replacement.

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):

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

Outcome Measures for this Clinical Trial

Primary:

  • 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.

Clinical Trials Locations, Contact Details, and Sponsors

Lead Sponsor: Merck

Msd Sharp & Dohme Gmbh

Haar  85540 Germany

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Additional Information

Information obtained from ClinicalTrials.gov on July 18, 2008

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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