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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Postoperative Dental Pain

Intervention / Treatment
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* Drug: Comparator: etoricoxib
* Drug: Comparator: ibuprofen
* Drug: Comparator: acetaminophen + codeine
* Drug: Comparator: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>etoricoxib 90 mg | Drug: Comparator: etoricoxib<br>* etoricoxib 90 mg; 120 mg (once daily) over three days.<br>|
| Experimental: 2<br>etoricoxib 120 mg | Drug: Comparator: etoricoxib<br>* etoricoxib 90 mg; 120 mg (once daily) over three days.<br>|
| Active Comparator: 3<br>ibuprofen 2400 mg | Drug: Comparator: ibuprofen<br>* ibuprofen 2400 mg (600 mg Q6h) over three Days<br>|
| Active Comparator: 4<br>acetaminophen 2400 mg/codeine 240 mg | Drug: Comparator: acetaminophen + codeine<br>* acetaminophen 2400 mg/codeine 240 mg (600/60 mg Q6h) over three Days<br>|
| Placebo Comparator: 5<br>Matching Placebo | Drug: Comparator: placebo<br>* matching placebo over three Days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Over the first 6 hours post the initial Day 1 dose of the study medication | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At 24 hours post the initial Day 1 dose of the study medication | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative Dental Pain