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A Study to Asses the Effect of MK0663 in the Treatment of Patients With Postoperative Dental Pain (0663-092)

Primary Purpose

Postoperative Dental Pain

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Comparator: etoricoxib
Comparator: ibuprofen
Comparator: acetaminophen + codeine
Comparator: placebo
Sponsored by
Organon and Co
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Dental Pain focused on measuring Postoperative Dental Pain

Eligibility Criteria

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

Inclusion Criteria:

  • Patients must be scheduled to have 2 or more third molars removed, at least 1 of which is partially embedded in bone and is impacted in the lower jaw
  • Patients must be experiencing moderate to severe pain following the dental procedure

Exclusion Criteria:

  • Previous molar extraction within the past 45 days
  • Personal or family history of an inherited bleeding disorder
  • Uncontrolled high blood pressure

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    1

    2

    3

    4

    5

    Arm Description

    etoricoxib 90 mg

    etoricoxib 120 mg

    ibuprofen 2400 mg

    acetaminophen 2400 mg/codeine 240 mg

    Matching Placebo

    Outcomes

    Primary Outcome Measures

    Total Pain Relief Score Over the First 6 Hours Post the Initial Day 1 Dose of the Study Medication (TOPAR6)
    TOPAR6 was calculated by multiplying the pain relief (PR) score (0- to 4-point Likert scale, with 0=None, and 4=Complete for pain relief) at each time point by the duration (in hours) since the preceding time point, and summing these weighted values up to 6 hours post the initial Day 1 dose. The range of TOPAR6 score is 0 to 24.

    Secondary Outcome Measures

    Patient's Global Assessment of Study Medication at 24 Hours Post the Initial Day 1 Dose of the Study Medication
    Patient's Global Assessment of Study Medication was on 0- to 4- point scale, with 0=Poor, and 4=Excellent for patient's rating of the study medication for pain.

    Full Information

    First Posted
    June 6, 2008
    Last Updated
    February 7, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00694369
    Brief Title
    A Study to Asses the Effect of MK0663 in the Treatment of Patients With Postoperative Dental Pain (0663-092)
    Official Title
    A Phase III Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Multiple-Dose Clinical Trial to Study the Efficacy and Safety of MK0663/Etoricoxib 90 and 120 mg, Ibuprofen 600 mg, and Acetaminophen 600 mg/Codeine 60 mg in the Treatment of Patients With Postoperative Dental Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2008 (undefined)
    Primary Completion Date
    December 2008 (Actual)
    Study Completion Date
    January 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Organon and Co

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to compare the pain relieving effect of different doses of MK0663 with placebo and other pain relievers/analgesics in patients with postoperative dental pain. Pain intensity and relief will be measured by the total pain relief score (TOPAR) and patient evaluation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Dental Pain
    Keywords
    Postoperative Dental Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    588 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    etoricoxib 90 mg
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    etoricoxib 120 mg
    Arm Title
    3
    Arm Type
    Active Comparator
    Arm Description
    ibuprofen 2400 mg
    Arm Title
    4
    Arm Type
    Active Comparator
    Arm Description
    acetaminophen 2400 mg/codeine 240 mg
    Arm Title
    5
    Arm Type
    Placebo Comparator
    Arm Description
    Matching Placebo
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: etoricoxib
    Intervention Description
    etoricoxib 90 mg; 120 mg (once daily) over three days.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: ibuprofen
    Intervention Description
    ibuprofen 2400 mg (600 mg Q6h) over three Days
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: acetaminophen + codeine
    Intervention Description
    acetaminophen 2400 mg/codeine 240 mg (600/60 mg Q6h) over three Days
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: placebo
    Intervention Description
    matching placebo over three Days
    Primary Outcome Measure Information:
    Title
    Total Pain Relief Score Over the First 6 Hours Post the Initial Day 1 Dose of the Study Medication (TOPAR6)
    Description
    TOPAR6 was calculated by multiplying the pain relief (PR) score (0- to 4-point Likert scale, with 0=None, and 4=Complete for pain relief) at each time point by the duration (in hours) since the preceding time point, and summing these weighted values up to 6 hours post the initial Day 1 dose. The range of TOPAR6 score is 0 to 24.
    Time Frame
    Over the first 6 hours post the initial Day 1 dose of the study medication
    Secondary Outcome Measure Information:
    Title
    Patient's Global Assessment of Study Medication at 24 Hours Post the Initial Day 1 Dose of the Study Medication
    Description
    Patient's Global Assessment of Study Medication was on 0- to 4- point scale, with 0=Poor, and 4=Excellent for patient's rating of the study medication for pain.
    Time Frame
    At 24 hours post the initial Day 1 dose of the study medication

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients must be scheduled to have 2 or more third molars removed, at least 1 of which is partially embedded in bone and is impacted in the lower jaw Patients must be experiencing moderate to severe pain following the dental procedure Exclusion Criteria: Previous molar extraction within the past 45 days Personal or family history of an inherited bleeding disorder Uncontrolled high blood pressure
    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
    23247002
    Citation
    Brown JD, Daniels SE, Bandy DP, Ko AT, Gammaitoni A, Mehta A, Boice JA, Losada MC, Peloso PM. Evaluation of multiday analgesia with etoricoxib in a double-blind, randomized controlled trial using the postoperative third-molar extraction dental pain model. Clin J Pain. 2013 Jun;29(6):492-8. doi: 10.1097/AJP.0b013e318260c144.
    Results Reference
    derived

    Learn more about this trial

    A Study to Asses the Effect of MK0663 in the Treatment of Patients With Postoperative Dental Pain (0663-092)

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