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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: MK0966; rofecoxib
• Drug: Comparator: diclofenac, placebo

Primary Measures

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

Secondary 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.

Inclusion Criteria:

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 59 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Merck

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00140933

Study ID Number: 2005_056

ClinicalTrials.gov Identifier: NCT00140933

Health Authority: France: Ministry of Health