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.
- 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.
- 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
Other protocol-defined inclusion/exclusion criteria may apply
William L Buchanan, M.D., D.D.S.
University of Texas Health Science Center, San Antonio, Texas