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

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ClinicalTrials.gov Identifier: NCT00140933
Recruitment Status : Terminated
First Posted : September 1, 2005
Last Update Posted : December 5, 2006
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment Phase
Pain Drug: MK0966; rofecoxib Drug: Comparator: diclofenac, placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 274 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : April 2003

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Pain during daily activities assessed by a Numerical Rating Score (NRS)

Secondary Outcome Measures :
  1. Functional impairment evaluated using Neer's functional index.
  2. Global assessment of disease activity by the patient with a NRS.
  3. Intensity of night pain evaluated by NRS.
  4. Rescue treatment take during the study duration.


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

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00140933


Locations
France
Laboratoires Merck Sharp & Dohme - Chibret
Paris Cedex 8, France, 75114
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

ClinicalTrials.gov Identifier: NCT00140933     History of Changes
Other Study ID Numbers: 2005_056
First Posted: September 1, 2005    Key Record Dates
Last Update Posted: December 5, 2006
Last Verified: December 2006

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
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase 2 Inhibitors