NCT00092339
Completed
Phase 3
A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Study to Evaluate the Effects of Rofecoxib 50 mg and Valdecoxib 40 mg in Patients With Postoperative Dental Pain
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Postoperative Pain
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 125
- Primary Endpoint
- Overall analgesic effect as measured by total pain relief over 12 hours.
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of pain following dental surgery.
Detailed Description
The duration of treatment is 1 day.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Impaction of a molar tooth requiring removal
Exclusion Criteria
- •Any known allergy to the study drugs
Outcomes
Primary Outcomes
Overall analgesic effect as measured by total pain relief over 12 hours.
Secondary Outcomes
- Time to onset of analgesic, peak analgesic and duration of analgesic effects.
- Percent of patients using and amount used of supplemental analgesia within 8, 12, and 24 hrs.
- Overall safety and tolerability.
- Overall analgesic effect over 8 hrs.
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