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

This study has been terminated.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00140933
First received: August 30, 2005
Last updated: December 1, 2006
Last verified: December 2006
History of Changes
  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 3

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:

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 June 17, 2013