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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: December 2008

Interventions

  • Drug: Comparator: etoricoxib
    • etoricoxib 90 mg; 120 mg (once daily) over three days.
  • Drug: Comparator: ibuprofen
    • ibuprofen 2400 mg (600 mg Q6h) over three Days
  • Drug: Comparator: acetaminophen + codeine
    • acetaminophen 2400 mg/codeine 240 mg (600/60 mg Q6h) over three Days
  • Drug: Comparator: placebo
    • matching placebo over three Days

Arms, Groups and Cohorts

  • Experimental: 1
    • etoricoxib 90 mg
  • Experimental: 2
    • etoricoxib 120 mg
  • Active Comparator: 3
    • ibuprofen 2400 mg
  • Active Comparator: 4
    • acetaminophen 2400 mg/codeine 240 mg
  • Placebo Comparator: 5
    • Matching Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Total Pain Relief Score Over the First 6 Hours Post the Initial Day 1 Dose of the Study Medication (TOPAR6)
    • Time Frame: Over the first 6 hours post the initial Day 1 dose of the study medication
    • 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 Measures

  • Patient’s Global Assessment of Study Medication at 24 Hours Post the Initial Day 1 Dose of the Study Medication
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Organon and Co
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Monitor, Study Director, Merck Sharp & Dohme LLC

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