A Study to Evaluate Rofecoxib Versus Placebo and Diclofenac in Patients With Acute Painful Rotator Cuff Syndrome

This study has been terminated.

First Received: August 30, 2005 Last Updated: December 1, 2006 History of Changes

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00140933

Purpose

Comparing the short-term efficacy of rofecoxib versus placebo. Patients receive rofecoxib or placebo or diclofenac and fill out a patient diary on daytime pain severity during daily activities, night pain severity, and acetaminophen/paracetamol intake.

Condition	Intervention	Phase
Pain	Drug: MK0966; rofecoxib Drug: Comparator: diclofenac, placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, 7-Day Study of the Efficacy and Safety of Rofecoxib Versus Placebo and Diclofenac in Patients With Acute Painful Rotator Cuff Syndrome

Resource links provided by NLM:

Drug Information available for: Diclofenac sodium Diclofenac potassium Diclofenac Rofecoxib

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Pain during daily activities assessed by a Numerical Rating Score (NRS)

Secondary Outcome Measures:

Functional impairment evaluated using Neer's functional index.
Global assessment of disease activity by the patient with a NRS.
Intensity of night pain evaluated by NRS.
Rescue treatment take during the study duration.

Estimated Enrollment:	274
Study Start Date:	April 2003

Eligibility

Ages Eligible for Study:	18 Years to 59 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males or females between the ages of 18 and 59 with acute painful rotator cuff syndrome.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00140933

Locations

France
Laboratoires Merck Sharp & Dohme - Chibret
Paris Cedex 8, France, 75114

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Study ID Numbers:	2005_056
Study First Received:	August 30, 2005
Last Updated:	December 1, 2006
ClinicalTrials.gov Identifier:	NCT00140933 History of Changes
Health Authority:	France: Ministry of Health

Additional relevant MeSH terms:

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

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

ClinicalTrials.gov processed this record on February 08, 2010