Dental Pain (Following Third Molar Tooth Extraction) Study

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Dental Pain; Surgery, Dental

Treatments: Drug: GW406381

Study type: Interventional

Funder types: Industry

Identifiers

NCT00114049

CXA30001

Details and patient eligibility

About

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.

Full 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

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind