A Study to Evaluate Rofecoxib Versus Placebo and Diclofenac in Patients With Acute Painful Rotator Cuff Syndrome
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: MK0966; rofecoxib (Drug); Comparator: diclofenac, placebo (Drug)
Phase: Phase 3
Sponsored by: Merck
Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
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.
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 design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Pain during daily activities assessed by a Numerical Rating Score (NRS)
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.
Minimum age: 18 Years.
Maximum age: 59 Years.
- Males or females between the ages of 18 and 59 with acute painful rotator cuff
Locations and Contacts
Laboratoires Merck Sharp & Dohme - Chibret, Paris Cedex 8 75114, France
Starting date: April 2003
Last updated: December 1, 2006