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

NCT03547232 · tracked via the Priya Life Science China tracker

Sponsor

Peking Union Medical College Hospital

Phase

Phase 4

Started

2024-12-01

Last updated

2025-06-15

Condition(s) studied

Acute PancreatitisComplicationMortality RateOrgan Failure, Multiple

Investigational drug(s) / intervention(s)

Indomethacin SRPlacebos

Indomethacin SR: Indomethacin SR 50mg given q12h from admission day 1 to day 7

Placebos: Similar shape and size suppositories (Placebos) without indomethacin given q12h from admission day 1 to day 7

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: * All patients ages 18-80 years with a diagnosis of AP based on at least 2 of the following criteria: * Abdominal pain characteristic of AP * Serum amylase and/or lipase ≥ 3 times the upper limit of normal * Characteristic findings of AP on abdominal CT scan will be screened for study enrollment. Exclusion Criteria: * Onset time \>24 hours * Presence of renal dysfunction (serum creatinine \> 1.5 \*normal upper limit) * Severe liver dysfunction * Active peptic ulcer disease or GI bleeding * Pregnancy or breast-feeding * Hypersensitivity to NSAIDs * New-onset, exacerbation or uncontrolled hypertension * Presence of serious cardiovascular events, including severe heart failure, myocardial infarction (MI) and stroke * Mental disability * Malignancy-associated acute pancreatitis * Post-ERCP pancreatitis * Informed consent not signed

Primary outcome measure(s)

Occurence rate of organ dysfunction caused by acute pancreatitis — 1 week
Accumulation of varied organ dysfunction, especially the cardiovascular, renal and respiratory systems

Trial sites (17)

Facility	City	Region	Status
Peking University Sixth Hospital	Beijing	Beijing Municipality	Recruiting
Peking Union Medical College Hospital	Beijing	Beijing Municipality	Recruiting
Liangxiang Hospital	Beijing	Beijing Municipality	Recruiting
Guiyang Second People's Hospital	Guiyang	Guizhou	Recruiting
Baoding Seventh Hospital	Baoding	Hebei	Recruiting
Fourth Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang	Recruiting
Dengzhou People's Hospital	Dengzhou	Henan	Recruiting
Second People Hospital of Nanyang	Nanyang	Henan	Recruiting
The Second People's Hospital of Huai'an	Huaian	Jiangsu	Recruiting
Nantong First People's Hospital	Nantong	Jiangsu	Recruiting
Suqian People's Hospital	Suqian	Jiangsu	Recruiting
Wuxi Third People's Hospital	Wuxi	Jiangsu	Recruiting
Qinghai University Affiliated Hospital	Xining	Qinghai	Recruiting
West China Longquan Hospital Sichuan University	Chengdu	Sichuan	Recruiting
The First Affiliated Hospital of Xinjiang Medical University	Ürümqi	Xinjiang	Recruiting
Jinhua Municipal Central Hospital	Jinhua	Zhejiang	Recruiting
Lishui Municipal Central Hospital	Lishui	Zhejiang	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03547232 on ClinicalTrials.gov ↗ ← All trials in China