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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00092378
• Other study ID #: 0966-234
• Secondary ID: 2004_072
• Status: Completed
• Phase: Phase 3
• First received: September 22, 2004
• Last updated: May 5, 2017
• Start date: September 1, 2003
• Est. completion date: December 1, 2003

Study information

• Verified date: May 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: December 1, 2003
• Est. primary completion date: December 1, 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Bunion removal

Exclusion Criteria:

• Any known allergies to the study design

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• MK0966, rofecoxib

• Comparator: diclofenac sodium, placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Desjardins PJ, Black PM, Daniels S, Bird SR, Fitzgerald BJ, Petruschke RA, Tershakovec A, Chang DJ. A randomized controlled study comparing rofecoxib, diclofenac sodium, and placebo in post-bunionectomy pain. Curr Med Res Opin. 2004 Oct;20(10):1523-37. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall analgesic effect over 8 hours
Secondary	Time to onset of analgesic effect.
Secondary	The use of supplemental analgesia on Days 2-3.
Secondary	Peak analgesic effect on Day 1.
Secondary	Overall safety and tolerability.
Secondary	The analgesic effect on Days 2-3.