A Phase IIA, Open-label, Safety and Pharmacokinetic Study of Indomethacin Capsules in Pediatric Subjects 6 to <17 Years of Age With Mild to Moderate Acute Postoperative Pain Following Elective Surgery

This was a phase IIA, multicenter, open-label, fixed-dose study. The study consisted of 3 periods: a Screening Period (Day -14 to Day -1, Preoperative Visit), a Treatment Period (Days 1-3), and a Follow-Up Period (Days 4-14).

Informed consent from the subject's legally authorized representative (parent/guardian) and assent (as applicable) from the subject were obtained before the subject underwent any protocol-specified procedures or assessments. Screening/Baseline data (including medical history, vital signs, physical examination, and clinical laboratory tests) were collected for each subject and used for initial assessment of eligibility. Clinical laboratory test results obtained before screening were acceptable for determining eligibility if they were collected within 1 week before the Screening/Baseline Visit. Subjects must have met all study entry criteria to be eligible for enrollment. To adequately assess the safety and tolerability of administering multiple doses of Tivorbex Capsules in this population, subjects who were likely to require multiple-day treatment for pain (preferably for the full 3-day treatment period) were enrolled.

As part of screening, subjects were required to demonstrate the ability to swallow a placebo capsule that corresponded in size to the study drug dose for their body weight. Eligible subjects were required to refrain from taking prohibited medications throughout the study. Prohibited analgesic medications taken at the time of the Screening/Baseline Visit were discontinued 12 hours before the first dose of study drug (perioperative analgesic/anesthetic medications given during the surgical procedure were exempt from this restriction) and were captured in the appropriate electronic case report form (eCRF).

Rescue medication as part of the postoperative treatment regimen was permitted according to the local standard of care unless contraindicated for use with Tivorbex. Subjects could receive the first dose of Tivorbex any time after surgery, following discontinuation of intravenous (IV) analgesics, oral opioids, or acetaminophen.

Subjects received the first dose of study drug at the site on Day 1. Four blood samples for PK analysis were collected at various time points via indwelling catheter over the first 12 hours after initial dosing.