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A phase 2 study of lower-dose, indomethacin submicron particle capsules demonstrates early onset of acute pain relief.

Clin J Pain

October 2014

*MIG Clinical Research Consulting, San Diego †Division of Rheumatology & Clinical Immunology, University of Maryland School of Medicine, Baltimore, MD ‡Premier Research Group International, LLC, Austin, TX §UCLA Medical Center RHU, Los Angeles, CA ∥Iroko Pharmaceuticals LLC, Philadelphia, PA.

Objectives: Nonsteroidal anti-inflammatory drugs are efficacious for the treatment of acute and chronic pain; however, they have the potential for serious adverse events (AEs). The objective of this study was to evaluate the efficacy and safety of investigational, lower-dose, indomethacin submicron particle capsules compared with placebo in a study of patients with postsurgical pain.

Materials And Methods: This phase 2, multicenter, randomized, double-blind, single-dose, and placebo-controlled study enrolled 203 patients (18 to 50 y old) following extraction of ≥ 2 third molars who experienced moderate-to-severe pain intensity ≤ 6 hours after surgery.

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