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Dental Pain (Following Third Molar Tooth Extraction) Study

This study has been completed.
Information provided by:
GlaxoSmithKline Identifier:
First received: June 13, 2005
Last updated: October 1, 2010
Last verified: October 2010
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.

Condition Intervention Phase
Dental Pain
Surgery, Dental
Drug: GW406381
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: See Detailed Description

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Difference between treatments over time based on pain intensity and pain relief scores.

Secondary Outcome Measures:
  • Difference between treatments based on changes in onset, duration of activity, overall effectiveness, and patient based assessments.

Estimated Enrollment: 300
Study Start Date: December 2004
Study Completion Date: April 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00114049

United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78703
Sponsors and Collaborators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

Responsible Party: Study Director, GSK Identifier: NCT00114049     History of Changes
Other Study ID Numbers: CXA30001 
Study First Received: June 13, 2005
Last Updated: October 1, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Dental Pain
Dental Surgery
Cox-2 inhibitor

Additional relevant MeSH terms:
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms processed this record on January 17, 2017