NCT00114049

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2004

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 14, 2005

Completed
Last Updated

January 19, 2017

Status Verified

January 1, 2017

Enrollment Period

4 months

First QC Date

June 13, 2005

Last Update Submit

January 18, 2017

Conditions

Dental PainSurgery, Dental

Keywords

Dental PainDental SurgeryCox-2 inhibitor

Outcome Measures

Primary Outcomes (1)

  • Difference between treatments over time based on pain intensity and pain relief scores.

Secondary Outcomes (1)

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

Interventions

GW406381DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled for outpatient surgical removal of at least two third molar teeth.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Austin, Texas, 78703, United States

Location

MeSH Terms

Conditions

Toothache

Interventions

GW406381X

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesFacial PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • GSK Clinical Trials, MD

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 13, 2005

First Posted

June 14, 2005

Study Start

December 1, 2004

Primary Completion

April 1, 2005

Study Completion

April 1, 2005

Last Updated

January 19, 2017

Record last verified: 2017-01

Locations

US(1)