Dental Pain (Following Third Molar Tooth Extraction) Study

GlaxoSmithKline300 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

300

Conditions

Dental Pain Surgery, Dental

Interventions

GW406381DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

GSK Investigational Site

Austin, Texas, United States

Outcomes

Primary Outcomes

Difference between treatments over time based on pain intensity and pain relief scores.

Secondary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.