Dental Pain (Following Third Molar Tooth Extraction) Study

Phase 3

Completed

• Conditions: Surgery, Dental; Dental Pain

• Registration Number: NCT00114049
• Lead Sponsor: GlaxoSmithKline

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

Study Timeline

• Study Start: 2004-12
• Primary Completion: 2005-04
• Study Completion: 2005-04
• Study First Submitted: 2005-06-13
• Study First Submitted QC: 2005-06-13
• Study First Posted: 2005-06-14
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-18
• Last Update Posted: 2017-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Austin, Texas, United States