Back to resultsA Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-183)
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0966, rofecoxib
Comparator: oxycodone with acetaminophen, placebo
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring dental surgery, molar removal
Eligibility Criteria
Inclusion Criteria: Impaction of a molar tooth requiring removal Exclusion Criteria: Any known allergy to the study drugs
Sites / Locations
Outcomes
Primary Outcome Measures
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 Outcome Measures
Time to onset of analgesic effect, peak analgesic effect, and/or duration of analgesic effect over 24 hours.
Full Information
NCT ID
NCT00092326
First Posted
September 22, 2004
Last Updated
February 19, 2016
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00092326
Brief Title
A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-183)
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
September 2002 (Actual)
Study Completion Date
September 2002 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
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 24 hours.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
dental surgery, molar removal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
269 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0966, rofecoxib
Intervention Type
Drug
Intervention Name(s)
Comparator: oxycodone with acetaminophen, placebo
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Time to onset of analgesic effect, peak analgesic effect, and/or duration of analgesic effect over 24 hours.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Impaction of a molar tooth requiring removal
Exclusion Criteria:
Any known allergy to the study drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
17656293
Citation
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. doi: 10.1016/j.joms.2006.06.268. No abstract available.
Results Reference
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A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-183)
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