Lower-dose diclofenac submicron particle capsules provide early and sustained acute patient pain relief in a phase 3 study.

摘要: Background: Non-steroidal anti-inflammatory drugs are prescribed for the treatment of patients with acute pain but use such analgesics is associated dose-dependent adverse events (AEs). Diclofenac submicron particle capsules have been developed using SoluMatrix technology to provide analgesia at lower doses than available solid oral dosing forms. Our study evaluated analgesic efficacy and safety lower-dose diclofenac in following elective surgery. Methods: A phase 3, multicenter, double-blind enrolled 428 patients, aged 18 65 years, moderate-to-severe bunionectomy under regional anesthesia. Patients experiencing a intensity rating > 40 mm on 100-mm Visual Analog Scale were randomized receive (35 or mg, 3 times daily [TID]), celecoxib (200 twice [BID], 400-mg loading dose), placebo. The primary parameter was overall (sum...