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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00694369
First received: June 6, 2008
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Postoperative Dental Pain
Drug: Comparator: etoricoxib
Drug: Comparator: ibuprofen
Drug: Comparator: acetaminophen + codeine
Drug: Comparator: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: At 24 hours post the initial Day 1 dose of the study medication ] [ Designated as safety issue: No ]
    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.


Enrollment: 588
Study Start Date: June 2008
Study Completion Date: January 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
etoricoxib 90 mg
Drug: Comparator: etoricoxib
etoricoxib 90 mg; 120 mg (once daily) over three days.
Experimental: 2
etoricoxib 120 mg
Drug: Comparator: etoricoxib
etoricoxib 90 mg; 120 mg (once daily) over three days.
Active Comparator: 3
ibuprofen 2400 mg
Drug: Comparator: ibuprofen
ibuprofen 2400 mg (600 mg Q6h) over three Days
Active Comparator: 4
acetaminophen 2400 mg/codeine 240 mg
Drug: Comparator: acetaminophen + codeine
acetaminophen 2400 mg/codeine 240 mg (600/60 mg Q6h) over three Days
Placebo Comparator: 5
Matching Placebo
Drug: Comparator: placebo
matching placebo over three Days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00694369

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided by Merck Sharp & Dohme Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00694369     History of Changes
Other Study ID Numbers: 0663-092, MK0663-092, 2008_506
Study First Received: June 6, 2008
Results First Received: November 13, 2009
Last Updated: November 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Postoperative Dental Pain

Additional relevant MeSH terms:
Toothache
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Pain
Signs and Symptoms
Acetaminophen
Ibuprofen
Etoricoxib
Codeine
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 15, 2014