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

Phase 3

Completed

• Conditions: Postoperative Dental Pain

• Registration Number: NCT00694369
• Lead Sponsor: Organon and Co

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-06
• Study First Submitted QC: 2008-06-09
• Study First Posted: 2008-06-10
• Primary Completion: 2008-12
• Study Completion: 2009-01
• Results First Submitted: 2009-11-13
• Results First Submitted QC: 2010-01-04
• Results First Posted: 2010-01-29
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 588

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Total Pain Relief Score Over the First 6 Hours Post the Initial Day 1 Dose of the Study Medication (TOPAR6)	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 Outcome Measures

Name	Time	Method
Patient's Global Assessment of Study Medication at 24 Hours Post the Initial Day 1 Dose of the 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.