NCT03547232

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

Rectal Indomethacin as Early Treatment for Acute Pancreatitis (INDOMAP Trial): Study Protocol for a Multi-center, Double-blinded, Placebo-controlled, Randomized Clinical Trial

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,504 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Pancreatitis
• Complication
• Mortality Rate
• Organ Failure, Multiple

Interventions

Type	Name	Description
DRUG	Indomethacin SR	Indomethacin SR 50mg given q12h from admission day 1 to day 7
DRUG	Placebos	Similar shape and size suppositories (Placebos) without indomethacin given q12h from admission day 1 to day 7

Timeline

• Start date: 2024-12-01
• Primary completion: 2028-06-01
• Completion: 2028-12-01
• First posted: 2018-06-06
• Last updated: 2025-06-15

Locations

17 sites across 1 country: China