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.
Drug: MK0966, rofecoxib
Drug: Comparator: diclofenac sodium, placebo
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|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|
- Overall analgesic effect over 8 hours
- 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.
|Study Start Date:||September 2003|
|Study Completion Date:||December 2003|
|Primary Completion Date:||December 2003 (Final data collection date for primary outcome measure)|
The duration of treatment is 5 days for rofecoxib and 1 day for diclofenac sodium.