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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00092326
First received: September 22, 2004
Last updated: November 7, 2014
Last verified: November 2014

September 22, 2004
November 7, 2014
June 2002
September 2002   (final data collection date for primary outcome measure)
Post-op dental pain over 6 hours as measured by pain intensity/relief scores, patient global assessment, and time to perceptible/meaningful pain relief.
Not Provided
Complete list of historical versions of study NCT00092326 on ClinicalTrials.gov Archive Site
Time to onset of analgesic effect, peak analgesic effect, and/or duration of analgesic effect over 24 hours.
Not Provided
Not Provided
Not Provided
 
A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-183)
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

The purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of pain following dental surgery.

The duration of treatment is 24 hours.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Postoperative Pain
  • Drug: MK0966, rofecoxib
  • Drug: Comparator: oxycodone with acetaminophen, placebo
Not Provided
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. No abstract available.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
269
September 2002
September 2002   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Impaction of a molar tooth requiring removal

Exclusion Criteria:

  • Any known allergy to the study drugs
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00092326
0966-183, 2004_068
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP