Expired Study
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Austin, Texas 78703


Purpose:

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.


Study summary:

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


Criteria:

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.


Study is Available At:


Original ID:

CXA30001


NCT ID:

NCT00114049


Secondary ID:


Study Acronym:


Brief Title:

Dental Pain (Following Third Molar Tooth Extraction) Study


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 Wit


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

GlaxoSmithKline


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

300


Enrollment Type:


Overall Contact Information

Official Name:GSK Clinical Trials, MD
Study Director
GlaxoSmithKline

Study Dates

Start Date:December 2004
Completion Date:April 2005
Completion Type:Actual
Primary Completion Date:April 2005
Primary Completion Type:Actual
Verification Date:January 2017
Last Changed Date:January 18, 2017
First Received Date:June 13, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:Difference between treatments over time based on pain intensity and pain relief scores.
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Difference between treatments based on changes in onset, duration of activity, overall effectiveness, and patient based assessments.
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:GW406381

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:GlaxoSmithKline

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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