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Cefaclor capsules |
Ceclor |
Clinical Trial: Dental Pain (Following Third Molar Tooth Extraction) Study
This study is no longer recruiting patients.
|
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
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
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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