A Study of Two Approved Drugs in the Treatment of Post-Bunionectomy Surgery Pain
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative Pain
Intervention: MK0966, rofecoxib (Drug); Comparator: diclofenac sodium, placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck
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.
Clinical Details
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
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Overall analgesic effect over 8 hours
Secondary outcome: 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.
Detailed description:
The duration of treatment is 5 days for rofecoxib and 1 day for diclofenac sodium.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Bunion removal
Exclusion Criteria:
- Any known allergies to the study design
Locations and Contacts
Additional Information
Related publications: 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.
Starting date: September 2003
Last updated: May 17, 2006
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