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

This study has been terminated.

First Received: August 30, 2005 Last Updated: September 24, 2009 History of Changes

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00140920

Purpose

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.

Condition	Intervention	Phase
Pain	Drug: MK0966; rofecoxib Drug: Comparator: diclofenac 2x 75 mg	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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.

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Diclofenac sodium Diclofenac potassium Diclofenac Rofecoxib

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Quantity of patient controlled
Post-operative morphine administration

Estimated Enrollment:	150
Study Start Date:	January 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males or females at least 18 years of age who have osteoarthritis of the knee and have undergone total knee joint replacement.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00140920

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Study ID Numbers:	2005_054, MK0966-259
Study First Received:	August 30, 2005
Last Updated:	September 24, 2009
ClinicalTrials.gov Identifier:	NCT00140920 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Diclofenac
Enzyme Inhibitors
Pain
Cyclooxygenase 2 Inhibitors
Pharmacologic Actions
Signs and Symptoms
Pathologic Processes

Postoperative Complications
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Rofecoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Pain, Postoperative

ClinicalTrials.gov processed this record on February 08, 2010