The purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of pain following dental surgery...
Date First Received: September 22, 2004
Last Updated: November 21, 2006
Verified by: Merck, September 2005
Clinical Trial Phase: Phase 3 | Start Date: August 2002
Overall Status: Completed
Estimated Enrollment: 125
Brief Summary
Official Title: “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”
Condition Keyword(s):
Intervention(s):
The purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of pain following dental surgery.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Detailed Clinical Trial Description
The duration of treatment is 1 day.
Outcome Measures for this Clinical Trial
Primary:
- Overall analgesic effect as measured by total pain relief over 12 hours.
Secondary:
- Overall analgesic effect over 8 hrs.
- 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.
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Impaction of a molar tooth requiring removal
Exclusion Criteria:
- Any known allergy to the study drugs
Clinical Trials Locations, Contact Details, and Sponsors
Lead Sponsor: Merck
Related Publications
References
Daniels SE, Desjardins PJ, Bird SR, Smugar SS, Tershakovec AM. Rofecoxib 50 mg and valdecoxib 20 or 40 mg in adults and adolescents with postoperative pain after third molar extraction: results of two randomized, double-blind, placebo-controlled, single-dose studies. Clin Ther. 2006 Jul;28(7):1022-34.
Additional Information
Information obtained from ClinicalTrials.gov on July 23, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00092339
Study ID Number: 2004_069
ClinicalTrials.gov Identifier: NCT00092339
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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