Dental Pain (Following Third Molar Tooth Extraction) Study

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double
  • Study Primary Completion Date: April 2005

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

Interventions

  • Drug: GW406381

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • GlaxoSmithKline
  • Provider of Information About this Clinical Study
    • Study Director, GSK
  • Overall Official(s)
    • GSK Clinical Trials, MD, Study Director, GlaxoSmithKline

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