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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.
Information provided by:
Merck Sharp & Dohme Corp. Identifier:
First received: August 30, 2005
Last updated: December 1, 2006
Last verified: December 2006
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
Drug: MK0966; rofecoxib
Drug: Comparator: diclofenac, placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
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:

Further study details as provided by Merck Sharp & Dohme Corp.:

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

Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Males or females between the ages of 18 and 59 with acute painful rotator cuff syndrome.
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Please refer to this study by its identifier: NCT00140933

Laboratoires Merck Sharp & Dohme - Chibret
Paris Cedex 8, France, 75114
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information Identifier: NCT00140933     History of Changes
Other Study ID Numbers: 2005_056
Study First Received: August 30, 2005
Last Updated: December 1, 2006

Additional relevant MeSH terms:
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents processed this record on April 26, 2017