Phase 3 N=588 Randomized Double-blind Treatment

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

Postoperative Dental Pain

Bottom Line

View on ClinicalTrials.gov: NCT00694369 ↗

Enrolled (actual)

588

Serious AEs

0.0%

Results posted

Jan 2010

Primary outcome: Primary: Total Pain Relief Score Over the First 6 Hours Post the Initial Day 1 Dose of the Study Medication (TOPAR6) — 5.08; 16.10; 15.73; 15.67 Units on a Scale — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Comparator: etoricoxib (Drug); Comparator: ibuprofen (Drug); Comparator: acetaminophen + codeine (Drug); Comparator: placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Organon and Co
Primary completion: Dec 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Total Pain Relief Score Over the First 6 Hours Post the Initial Day 1 Dose of the Study Medication (TOPAR6)	5.08; 16.10; 15.73; 15.67; 11.83	<0.001 sig
SECONDARY Patient's Global Assessment of Study Medication at 24 Hours Post the Initial Day 1 Dose of the Study Medication	19; 12; 7; 6; 1; 12	<0.001 sig

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00694369). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.