This purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of pain following bunionectomy surgery...
Date First Received: September 22, 2004
Last Updated: May 17, 2006
Verified by: Merck, October 2005
Clinical Trial Phase: Phase 3 | Start Date: September 2003
Overall Status: Completed
Estimated Enrollment: 240
Brief Summary
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”
Condition Keyword(s):
Intervention(s):
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 Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Detailed Clinical Trial Description
The duration of treatment is 5 days for rofecoxib and 1 day for diclofenac sodium.
Intervention(s) in this Clinical Trial
- Drug: MK0966, rofecoxib
- Drug: Comparator: diclofenac sodium, placebo
Outcome Measures for this Clinical Trial
Primary Measures
- Overall analgesic effect over 8 hours
Secondary Measures
- Time to onset of analgesic effect.
- The use of supplemental analgesia on Days 2-3.
- Peak analgesic effect on Day 1.
- Overall safety and tolerability.
- The analgesic effect on Days 2-3.
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Bunion removal
Exclusion Criteria:
- Any known allergies to the study design
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Merck
Related Publications
References
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.
Additional Information
Information obtained from ClinicalTrials.gov on August 28, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00092378
Study ID Number: 2004_072
ClinicalTrials.gov Identifier: NCT00092378
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
