Back to resultsDental Pain (Following Third Molar Tooth Extraction) Study
Primary Purpose
Dental Pain, Surgery, Dental
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
GW406381
Sponsored by
About this trial
This is an interventional treatment trial for Dental Pain focused on measuring Dental Pain, Dental Surgery, Cox-2 inhibitor
Eligibility 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.
Sites / Locations
- GSK Investigational Site
Outcomes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00114049
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 With Pain Following Third Molar Tooth Extraction
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
April 2005 (Actual)
Study Completion Date
April 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Pain, Surgery, Dental
Keywords
Dental Pain, Dental Surgery, Cox-2 inhibitor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
300 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
GW406381
Primary Outcome Measure Information:
Title
Difference between treatments over time based on pain intensity and pain relief scores.
Secondary Outcome Measure Information:
Title
Difference between treatments based on changes in onset, duration of activity, overall effectiveness, and patient based assessments.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials, MD
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78703
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Dental Pain (Following Third Molar Tooth Extraction) Study
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