A Study of Two Approved Drugs in the Treatment of Post-Bunionectomy Surgery Pain (0966-234)(COMPLETED)
Phase 3
Completed
- Conditions
- Postoperative Pain
- Registration Number
- NCT00092378
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief 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.
- Detailed Description
The duration of treatment is 5 days for rofecoxib and 1 day for diclofenac sodium.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 251
Inclusion Criteria
- Bunion removal
Exclusion Criteria
- Any known allergies to the study design
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Overall analgesic effect over 8 hours
- Secondary Outcome Measures
Name Time Method Time to onset of analgesic effect. The use of supplemental analgesia on Days 2-3. Overall safety and tolerability. The analgesic effect on Days 2-3. Peak analgesic effect on Day 1.
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms distinguish rofecoxib's COX-2 inhibition from diclofenac sodium's dual COX-1/COX-2 blockade in post-bunionectomy pain management?
How does rofecoxib's efficacy in postoperative pain compare to diclofenac sodium as a standard-of-care NSAID in Phase 3 trials?
Which biomarkers correlate with analgesic response to rofecoxib versus diclofenac sodium in foot surgery recovery?
What cardiovascular risks were observed in rofecoxib trials compared to diclofenac sodium for acute postoperative pain?
How do rofecoxib's pharmacokinetics and COX-2 selectivity influence its safety profile versus non-selective NSAIDs in Merck's post-bunionectomy study?