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

Postoperative Dental Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00694369
• Other study ID #: 0663-092
• Secondary ID: MK0663-0922008_5
• Status: Completed
• Phase: Phase 3
• Start date: June 2008
• Est. completion date: January 2009

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 588
• Est. completion date: January 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Dental Pain
• Toothache

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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