A Study 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

Key Inclusion Criteria:

• Patients requiring surgical removal of 2 ipsilateral third molars, of which themandibular must be fully or partially impacted. The ipsilateral maxillary third molarmay 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 bya VASPI score of ≥ 50 mm within 5 hours of surgical completion, after local anestheticdissipation.

Key Exclusion Criteria:

• Patients who require the removal of a single third molar, or 2 ipsilateral thirdmolars where mandibular molar is not fully or partially impacted.

• Patients with active peptic ulcer disease or a history of significant gastrointestinaldisease 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 administrationof study drug (other than surgical anesthetic prior to and during dental surgery).