Dental Pain (Following Third Molar Tooth Extraction) Study - Article Orazinc; Verazinc; Zinc 15; Zinc Gluconate; Zinc Sulfate; Zincate
Clinical Trial: Dental Pain (Following Third Molar Tooth Extraction) Study
This study is no longer recruiting patients.
| 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
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
Accepts Healthy Volunteers
- Scheduled for outpatient surgical removal of at least two third molar teeth.
- 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.
78703PPD Dental Clinic, Austin, Texas, 78703, United States
GSK Clinical Trials, Study Director, GlaxoSmithKline
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