A Study of Two Approved Drugs in the Treatment of Post-Bunionectomy Surgery Pain (0966-234)(COMPLETED)

May 5, 2017 updated by: Merck Sharp & Dohme LLC

A Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled, Parallel-Group Study of Rofecoxib and Diclofenac Sodium in the Treatment of Post-Bunionectomy Surgery Pain

This purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of pain following bunionectomy surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The duration of treatment is 5 days for rofecoxib and 1 day for diclofenac sodium.

Study Type

Interventional

Enrollment (Actual)

251

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Bunion removal

Exclusion Criteria:

  • Any known allergies to the study design

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall analgesic effect over 8 hours

Secondary Outcome Measures

Outcome Measure
Overall safety and tolerability.
Time to onset of analgesic effect.
The use of supplemental analgesia on Days 2-3.
Peak analgesic effect on Day 1.
The analgesic effect on Days 2-3.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2003

Primary Completion (Actual)

December 1, 2003

Study Completion (Actual)

December 1, 2003

Study Registration Dates

First Submitted

September 22, 2004

First Submitted That Met QC Criteria

September 24, 2004

First Posted (Estimate)

September 27, 2004

Study Record Updates

Last Update Posted (Actual)

May 9, 2017

Last Update Submitted That Met QC Criteria

May 5, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0966-234
  • 2004_072

Plan for Individual participant data (IPD)

Study Data/Documents

  1. CSR Synopsis

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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