Early Treatment of Acute Pancreatitis with Rectal Indomethacin in Adults Aged 18 to 80 A Multi-center, Double-blind, Placebo-controlled Phase 4 Trial

What this Trial Is About

Researchers are evaluating the use of indomethacin, a non-steroidal anti-inflammatory drug NSAID, as an early treatment for acute pancreatitis AP, a condition where the pancreas becomes inflamed due to enzyme activation. The study aims to clarify the effects of NSAIDs on AP treatment, as previous animal studies suggested potential benefits but clinical evidence has been inconsistent. This Phase 4, multi-center, double-blinded, placebo-controlled trial seeks to provide high-quality data on this topic. Participants will be randomly assigned to receive either indomethacin SR 50 mg suppositories every 12 hours from admission day 1 to day 7 alongside standard AP treatments or similar placebo suppositories on the same schedule with standard care. Standard treatment includes adequate intravenous fluids, pain relief, and early enteral nutrition if possible. The study compares these two groups to assess the impact of indomethacin on AP outcomes. During the study, participants will be monitored for organ dysfunction related to AP over one week, which is the primary outcome. Secondary outcomes include rates of pancreatic necrosis, ICU admission, and mortality within one month. Assessments will involve clinical evaluations and imaging. The study runs from admission through at least one month, with close safety monitoring and follow-up to understand treatment effects and patient health outcomes over time.

Rectal Indomethacin as Early Treatment for Acute Pancreatitis (INDOMAP Trial)