A Study to Evaluate Rofecoxib Versus Placebo and Diclofenac in Patients With Acute Painful Rotator Cuff Syndrome
Phase 3
Terminated
- Conditions
- Pain
- Registration Number
- NCT00140933
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 274
Inclusion Criteria
- Males or females between the ages of 18 and 59 with acute painful rotator cuff syndrome.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Pain during daily activities assessed by a Numerical Rating Score (NRS)
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Laboratoires Merck Sharp & Dohme - Chibret
🇫🇷Paris Cedex 8, France