NCT00140933

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
274

participants targeted

Target at P50-P75 for phase_3 pain

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2005

Completed
Last Updated

December 5, 2006

Status Verified

December 1, 2006

First QC Date

August 30, 2005

Last Update Submit

December 1, 2006

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

  • 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.

Interventions

MK0966; rofecoxibDRUG
Comparator: diclofenac, placeboDRUG

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratoires Merck Sharp & Dohme - Chibret

Paris, 75114, France

Location

Related Publications (1)

  • Jones P, Lamdin R, Dalziel SR. Oral non-steroidal anti-inflammatory drugs versus other oral analgesic agents for acute soft tissue injury. Cochrane Database Syst Rev. 2020 Aug 12;8(8):CD007789. doi: 10.1002/14651858.CD007789.pub3.

    PMID: 32797734DERIVED

MeSH Terms

Conditions

Pain

Interventions

rofecoxib

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 30, 2005

First Posted

September 1, 2005

Study Start

April 1, 2003

Last Updated

December 5, 2006

Record last verified: 2006-12

Locations

FR(1)