Clinical Trial

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

Study acronym: INDOMAP
Recruiting Phase 4
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Summary
Acute pancreatitis (AP) is an inflammatory condition of the pancreas following the activated pancreatic enzymes induced by varied causes, with or without other organ(s) dysfunction. The production and release of inflammatory factors is generally considered as the key factor of pathogenesis. Non-steroidal anti-inflammatory drugs (NSAIDs) are the most commonly applied agents for inflammatory diseases. A series studies have proved that indomethacin can reduce the risk of post-endoscopic retrograde cholangiopancreatography (ERCP), but high-quality evidence is still lacking in the field of effectiveness of NSAIDs to treat, rather than prevent, other types of AP. Majority of animal experiments showed that NSAIDs had protective effects for organ functions, but the results of several preliminary clinical studies were inconsistent. Randomized controlled trials are eagerly awaited to elucidate its effects on AP.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2018-05-24; most recent amendment 2025-06-11.
Status change: Not Yet Recruiting → Recruiting 2018-06-24
Trial Details
NCT Number NCT03547232
Lead Sponsor Peking Union Medical College Hospital
Conditions Acute Pancreatitis, Complication, Mortality Rate, Organ Failure, Multiple
Enrollment 1,504 participants
Start Date 2024-12-01
Primary Completion 2028-06-01 (estimated)
Study Completion 2028-12-01 (estimated)
Updated on ClinicalTrials.gov 2025-06-15