Clinical Trial: Dental Pain (Following Third Molar Tooth Extraction) Study

This study is no longer recruiting patients.

Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline

Purpose

A placebo-controlled study to assess the safety and efficacy of an investigational compound in patients with dental pain following third molar tooth extraction.
Condition Intervention Phase
Pain
Postoperative Pain
 Drug: GW406381 oral capsules
 Drug: naproxen sodium oral capsules
Phase III

MedlinePlus related topics:  Pain

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy 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

Further Study Details: 
Primary Outcomes: Difference between treatments over time based on pain intensity and pain relief scores.
Secondary Outcomes: Difference between treatments based on changes in onset, duration of activity, overall effectiveness, and patient based assessments.
Expected Total Enrollment:  300

Study start: December 2004

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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.

Location Information


Texas
      78703PPD Dental Clinic, Austin,  Texas,  78703,  United States

Study chairs or principal investigators

GSK Clinical Trials,  Study Director,  GlaxoSmithKline   

More Information

Study ID Numbers:  CXA30001
Record last reviewed:  June 2005
Last Updated:  June 30, 2005
Record first received:  June 13, 2005
ClinicalTrials.gov Identifier:  NCT00114049
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-05

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