A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-181)(COMPLETED)

A Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled, Single Dose Study of the Effect of Rofecoxib 50 mg and Valdecoxib 20 mg in Patients With Postoperative Dental Pain

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00092300

Enrollment

450

Registered

2004-09-28

Start date

2002-05-31

Completion date

Unknown

Last updated

2015-08-04

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 1 day.

Interventions

DRUGMK0966, rofecoxib

DRUGComparator: valdecoxib

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 allergies to the study drug

Design outcomes

Primary

Measure	Time frame
Overall analgesic effect over 12 hours.	—

Secondary

Measure	Time frame
Overall analgesic effect over 8 hours.	—
Time to onset of analgesic, peak analgesic and duration of analgesic effects.	—
Overall analgesic, time to onset of analgesic, peak analgesic, and duration analgesic effects	—
Safety and tolerability.	—

Outcome results

None listed

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