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Dental Pain (Following Third Molar Tooth Extraction) Study

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ClinicalTrials.gov Identifier: NCT00114049
Recruitment Status : Completed
First Posted : June 14, 2005
Last Update Posted : January 19, 2017
Sponsor:
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Dental Pain Surgery, Dental Drug: GW406381 Phase 3

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : December 2004
Primary Completion Date : April 2005
Study Completion Date : April 2005
Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Difference between treatments over time based on pain intensity and pain relief scores.

Secondary Outcome Measures :
  1. Difference between treatments based on changes in onset, duration of activity, overall effectiveness, and patient based assessments.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00114049


Locations
United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78703
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
More Information

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00114049     History of Changes
Other Study ID Numbers: CXA30001
First Posted: June 14, 2005    Key Record Dates
Last Update Posted: January 19, 2017
Last Verified: January 2017

Keywords provided by GlaxoSmithKline:
Dental Pain
Dental Surgery
Cox-2 inhibitor

Additional relevant MeSH terms:
Toothache
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms