A Study of Two Approved Drugs 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...
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”
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
- Study Primary Completion Date: December 2003
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 Investigator Information
Lead Investigator: Merck Industry
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director 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 February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00092378
