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Completed

NCT Number: NCT00114049

Dental Pain (Following Third Molar Tooth Extraction) Study

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.

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Key information

Conditions

Dental Pain Facial Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases Surgery, Dental Tooth Diseases Toothache

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site

Austin, Texas, 78703, United States

About this 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GW406381

Drug

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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Jun 14, 2005
Registry last updated
Jan 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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