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A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-182)

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0966, rofecoxib
Comparator: oxycodone and acetaminophen
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring dental surgery, molar removal

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Impaction of a molar tooth requiring removal Exclusion Criteria: 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

    First Posted
    September 22, 2004
    Last Updated
    November 24, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00092313
    Brief Title
    A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-182)
    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
    November 2015
    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
    271 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    MK0966, rofecoxib
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: oxycodone and acetaminophen
    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: 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
    15200753
    Citation
    Chang DJ, Desjardins PJ, Bird SR, Black P, Chen E, Petruschke RA, Geba GP. Comparison of rofecoxib and a multidose oxycodone/ acetaminophen regimen for the treatment of acute pain following oral surgery: a randomized controlled trial. Curr Med Res Opin. 2004 Jun;20(6):939-49. doi: 10.1185/030079904125003863.
    Results Reference
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    A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-182)

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