A Study of Two Approved Drugs in the Treatment of Post-Bunionectomy Surgery Pain (0966-234)(COMPLETED)
Overview
This purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of pain following bunionectomy surgery.
Full Title of Study: “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”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: December 1, 2003
Detailed Description
The duration of treatment is 5 days for rofecoxib and 1 day for diclofenac sodium.
Interventions
- Drug: MK0966, rofecoxib
- Drug: Comparator: diclofenac sodium, placebo
Clinical Trial Outcome Measures
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.
Participating in This Clinical Trial
Inclusion Criteria
- Bunion removal Exclusion Criteria:
- Any known allergies to the study design
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Medical Monitor, Study Director, Merck Sharp & Dohme LLC
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. doi: 10.1185/030079904X3069.
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