Last updated: 11/04/2018 06:06:41

Dental Pain (Following Third Molar Tooth Extraction) Study

GSK study ID
CXA30001
Clinicaltrials.gov ID
NCT00114049
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: GW406381
    • Enrollment:
    300
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Dental Pain, Surgery, Dental
    Product
    GW406381
    Collaborators
    Not applicable
    Study date(s)
    December 2004 to April 2005
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    no
    • Inclusion criteria:
    • Scheduled for outpatient surgical removal of at least two third molar teeth.
    Inclusion and exclusion criteria
    Inclusion 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Austin, Texas, United States, 78703
    Status
    Study Complete
    Contact us

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2005-20-04

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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