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

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00140933

Enrollment

274

Registered

2005-09-01

Start date

2003-04-30

Completion date

Unknown

Last updated

2006-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

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.

Interventions

DRUGMK0966; rofecoxib

DRUGComparator: diclofenac, placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 59 Years

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Pain during daily activities assessed by a Numerical Rating Score (NRS)	—

Secondary

Measure	Time frame
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.	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026