A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-190)(COMPLETED)

A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Study to Evaluate the Effects of Rofecoxib 50 mg and Valdecoxib 40 mg in Patients With Postoperative Dental Pain

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00092339

Enrollment

125

Registered

2004-09-27

Start date

2002-08-01

Completion date

2002-09-15

Last updated

2017-05-09

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, placebo

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

* Any known allergy to the study drugs

Design outcomes

Primary

Measure	Time frame
Overall analgesic effect as measured by total pain relief over 12 hours.	—

Secondary

Measure	Time frame
Overall analgesic effect over 8 hrs.	—
Time to onset of analgesic, peak analgesic and duration of analgesic effects.	—
Percent of patients using and amount used of supplemental analgesia within 8, 12, and 24 hrs.	—
Overall safety and tolerability.	—

Outcome results

None listed

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