Back to resultsA Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-181)(COMPLETED)
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0966, rofecoxib
Comparator: valdecoxib
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: Known allergies to the study drug
Sites / Locations
Outcomes
Primary Outcome Measures
Overall analgesic effect over 12 hours.
Secondary Outcome Measures
Overall analgesic effect over 8 hours.
Time to onset of analgesic, peak analgesic and duration of analgesic effects.
Overall analgesic, time to onset of analgesic, peak analgesic, and duration analgesic effects
Safety and tolerability.
Full Information
NCT ID
NCT00092300
First Posted
September 22, 2004
Last Updated
July 31, 2015
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00092300
Brief Title
A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-181)(COMPLETED)
Official Title
A Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled, Single Dose Study of the Effect of Rofecoxib 50 mg and Valdecoxib 20 mg in Patients With Postoperative Dental Pain
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
September 2002 (Actual)
Study Completion Date
undefined (undefined)
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 1 day.
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
450 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0966, rofecoxib
Intervention Type
Drug
Intervention Name(s)
Comparator: valdecoxib
Primary Outcome Measure Information:
Title
Overall analgesic effect over 12 hours.
Secondary Outcome Measure Information:
Title
Overall analgesic effect over 8 hours.
Title
Time to onset of analgesic, peak analgesic and duration of analgesic effects.
Title
Overall analgesic, time to onset of analgesic, peak analgesic, and duration analgesic effects
Title
Safety and tolerability.
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:
Known allergies to the study drug
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
16990080
Citation
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. doi: 10.1016/j.clinthera.2006.07.005.
Results Reference
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Learn more about this trial
A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-181)(COMPLETED)
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