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Clinical Trials/NCT00092339
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

Merck Sharp & Dohme LLC0 sites125 target enrollmentAugust 1, 2002

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2002
End Date
September 15, 2002
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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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