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

This study has been terminated.

First Received on August 30, 2005. Last Updated on 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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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

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

Additional relevant MeSH terms:

Diclofenac
Rofecoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012