search
Back to results

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
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: 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

    First Posted
    September 22, 2004
    Last Updated
    May 5, 2017
    Sponsor
    Merck Sharp & Dohme LLC
    search

    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)

    We'll reach out to this number within 24 hrs