NCT00092378
Completed
Phase 3
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
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Postoperative Pain
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 251
- Primary Endpoint
- Overall analgesic effect over 8 hours
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Bunion removal
Exclusion Criteria
- •Any known allergies to the study design
Outcomes
Primary Outcomes
Overall analgesic effect over 8 hours
Secondary Outcomes
- Peak analgesic effect on Day 1.
- Overall safety and tolerability.
- The analgesic effect on Days 2-3.
- Time to onset of analgesic effect.
- The use of supplemental analgesia on Days 2-3.
Similar Trials
Completed
Phase 3
A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-181)(COMPLETED)Postoperative PainNCT00092300Merck Sharp & Dohme LLC450
Completed
Phase 3
A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-182)Postoperative PainNCT00092313Merck Sharp & Dohme LLC271
Completed
Phase 3
A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-183)Postoperative PainNCT00092326Merck Sharp & Dohme LLC269
Completed
Phase 3
A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-190)(COMPLETED)Postoperative PainNCT00092339Merck Sharp & Dohme LLC125
Completed
Phase 3
A Study of Two Approved Drugs in Patients With Osteoarthritis (0966-219)OsteoarthritisNCT00092352Merck Sharp & Dohme LLC395