Dental Pain (Following Third Molar Tooth Extraction) Study

Dental Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00114049
• Other study ID #: CXA30001
• Status: Completed
• Phase: Phase 3
• First received: June 13, 2005
• Last updated: January 18, 2017
• Start date: December 2004
• Est. completion date: April 2005

Study information

• Verified date: January 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: April 2005
• Est. primary completion date: April 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dental Pain
• Surgery, Dental
• Toothache

Intervention

Drug:
• GW406381

Locations

Country	Name	City	State
United States	GSK Investigational Site	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between treatments over time based on pain intensity and pain relief scores.
Secondary	Difference between treatments based on changes in onset, duration of activity, overall effectiveness, and patient based assessments.