Dental Pain (Following Third Molar Tooth Extraction) Study

A Pivotal Phase III, Single Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Dose-Ranging Study to Investigate the Efficacy and Safety of Single Oral Doses of 10mg, 25mg, 50mg and 70mg GW406381 and 550mg Naproxen Sodium in Subjects With Pain Following Third Molar Tooth Extraction

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00114049

Enrollment

300

Registered

2005-06-14

Start date

2004-12-31

Completion date

2005-04-30

Last updated

2017-01-19

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

Conditions

Dental Pain, Surgery, Dental

Keywords

Dental Pain, Dental Surgery, Cox-2 inhibitor

Brief summary

The purpose of this study is to evaluate the effectiveness of GW406381 (a COX-2 inhibitor) in treating the signs and symptoms of dental pain following third molar tooth extraction.

Detailed description

A Pivotal Phase III, Single Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Dose-Ranging Study to Investigate the Efficacy and Safety of Single Oral Doses of 10mg, 25mg, 50mg, and 70mg GW406381 and 550mg Naproxen Sodium in Subjects With Pain Following Third Molar Tooth Extraction

Interventions

DRUGGW406381

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Scheduled for outpatient surgical removal of at least two third molar teeth.

Exclusion criteria

* Subjects who do not achieve moderate to severe pain. * Subjects who do not use acceptable contraception. * Additional medical criteria will be assessed by the investigator.

Design outcomes

Primary

Measure	Time frame
Difference between treatments over time based on pain intensity and pain relief scores.	—

Secondary

Measure	Time frame
Difference between treatments based on changes in onset, duration of activity, overall effectiveness, and patient based assessments.	—

Countries

United States

Outcome results

None listed

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