A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-182)

A Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Study to Evaluate the Efficacy of Rofecoxib and a Dosing Regimen of Oxycodone With Acetaminophen Over 24 Hours in Patients With Postoperative Dental Pain

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00092313

Enrollment

271

Registered

2004-09-27

Start date

2002-06-30

Completion date

2002-09-30

Last updated

2015-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Keywords

dental surgery, molar removal

Brief summary

The purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of pain following dental surgery.

Detailed description

The duration of treatment is 24 hours.

Interventions

DRUGComparator: oxycodone and acetaminophen

DRUGMK0966, rofecoxib

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

Inclusion criteria

* Impaction of a molar tooth requiring removal

Exclusion criteria

* Known allergy to the study drugs

Design outcomes

Primary

Measure	Time frame
Post-op dental pain over 6 hours as measured by pain intensity/relief scores, patient global assessment, and time to perceptible/meaningful pain relief.	—

Secondary

Measure	Time frame
Time to onset of analgesic effect, peak analgesic effect, and/or duration of analgesic effect over 24 hours.	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026