Expired Study
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Austin, Texas 78744


Purpose:

The study is designed to assess the efficacy and tolerability of diclofenac potassium soft gelatin capsules compared with ibuprofen tablets in patients with moderate to severe postoperative dental pain.


Criteria:

Inclusion Criteria: - Patients requiring surgical removal of 2 ipsilateral third molars, of which the mandibular must be fully or partially impacted. The ipsilateral maxillary third molar may be of any impaction level. - Patients having a moderate to severe Baseline pain intensity as assessed by a score of 2 (moderate) or 3 (severe) on the 4-point categorical pain intensity VRS, confirmed by a VASPI score of ≥ 50 mm within 5 hours of surgical completion, after local anesthetic dissipation. Exclusion Criteria: - Patients who require the removal of a single third molar, or 2 ipsilateral third molars where mandibular molar is not fully or partially impacted. - Patients with active peptic ulcer disease or a history of significant gastrointestinal disease or any gastrointestinal bleeding. - Patients with coagulation or bleeding disorders. - Patients with a positive drug or alcohol screen. - Patients who have received an anti-inflammatory agent, analgesic, sedative, hypnotic, muscle relaxant, or tranquilizer within 5 elimination half-lives before administration of study drug (other than surgical anesthetic prior to and during dental surgery). Other protocol-defined inclusion/exclusion criteria may apply


NCT ID:

NCT02476422


Primary Contact:

Principal Investigator
William L Buchanan, M.D., D.D.S.
University of Texas Health Science Center, San Antonio, Texas


Backup Contact:

N/A


Location Contact:

Austin, Texas 78744
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 21, 2017

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