A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-183)

Postoperative Pain Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Study to Evaluate the Efficacy of Rofecoxib and a Dosing Regimen of Oxycodone With Acetaminophen Over 24 Hours in Patients With Postoperative Dental Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00092326
• Other study ID #: 0966-183
• Secondary ID: 2004_068
• Status: Completed
• Phase: Phase 3
• First received: September 22, 2004
• Last updated: February 19, 2016
• Start date: June 2002
• Est. completion date: September 2002

Study information

• Verified date: February 2016
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

The duration of treatment is 24 hours.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 269
• Est. completion date: September 2002
• Est. primary completion date: September 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Impaction of a molar tooth requiring removal

Exclusion Criteria:

• Any known allergy to the study drugs

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• MK0966, rofecoxib

• Comparator: oxycodone with acetaminophen, placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Desjardins PJ, Black PM, Daniels SE, Bird SR, Petruschke RA, Chang DJ, Smugar SS, Tershakovec AM. A double-blind randomized controlled trial of rofecoxib and multidose oxycodone/acetaminophen in dental impaction pain. J Oral Maxillofac Surg. 2007 Aug;65(8):1624-32. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-op dental pain over 6 hours as measured by pain intensity/relief scores, patient global assessment, and time to perceptible/meaningful pain relief.
Secondary	Time to onset of analgesic effect, peak analgesic effect, and/or duration of analgesic effect over 24 hours.