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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00114049
Other study ID # CXA30001
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
See also
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