A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-190)(COMPLETED)
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0966, rofecoxib
Comparator: valdecoxib, 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
Overall analgesic effect as measured by total pain relief over 12 hours.
Secondary Outcome Measures
Overall analgesic effect over 8 hrs.
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.
Full Information
NCT ID
NCT00092339
First Posted
September 22, 2004
Last Updated
May 5, 2017
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00092339
Brief Title
A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-190)(COMPLETED)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
August 1, 2002 (Actual)
Primary Completion Date
September 15, 2002 (Actual)
Study Completion Date
September 15, 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 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
125 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0966, rofecoxib
Intervention Type
Drug
Intervention Name(s)
Comparator: valdecoxib, placebo
Primary Outcome Measure Information:
Title
Overall analgesic effect as measured by total pain relief over 12 hours.
Secondary Outcome Measure Information:
Title
Overall analgesic effect over 8 hrs.
Title
Time to onset of analgesic, peak analgesic and duration of analgesic effects.
Title
Percent of patients using and amount used of supplemental analgesia within 8, 12, and 24 hrs.
Title
Overall 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:
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
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
background
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-190)(COMPLETED)
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