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

Pain Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00140933
• Other study ID #: 2005_056
• Status: Terminated
• Phase: Phase 3
• First received: August 30, 2005
• Last updated: December 1, 2006
• Start date: April 2003

Study information

• Verified date: December 2006
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 274
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 59 Years

Eligibility

Inclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• MK0966; rofecoxib

• Comparator: diclofenac, placebo

Locations

Country	Name	City	State
France	Laboratoires Merck Sharp & Dohme - Chibret	Paris Cedex 8

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain during daily activities assessed by a Numerical Rating Score (NRS)
Secondary	Functional impairment evaluated using Neer's functional index.
Secondary	Global assessment of disease activity by the patient with a NRS.
Secondary	Intensity of night pain evaluated by NRS.
Secondary	Rescue treatment take during the study duration.