Using Indomethacin to Treat Acute Pancreatitis
Official title: Rectal Indomethacin as Early Treatment for Acute Pancreatitis (INDOMAP Trial): Study Protocol for a Multi-center, Double-blinded, Placebo-controlled, Randomized Clinical Trial
Run by Peking Union Medical College Hospital · NCT03547232 · Data updated 2026-11-12
This study is testing if giving indomethacin through the rectum can help people with acute pancreatitis have fewer complications and live longer.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 1504 (estimated) |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Locations | 17 sites (Beijing, Beijing Municipality and 16 other locations) |
| Status | Recruiting |
| Started | December 1, 2024 |
| Main results expected | June 1, 2028 |
| Study ends | December 1, 2028 |
| Registry record updated | June 15, 2025 |
| Trial ID | NCT03547232 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-80 who have been diagnosed with acute pancreatitis based on specific clinical criteria.
✕Probably not a fit
Patients with renal dysfunction, active peptic ulcer disease, or those who are pregnant or breastfeeding may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial investigates the effectiveness of rectal indomethacin as an early treatment for acute pancreatitis, a condition characterized by inflammation of the pancreas. Patients aged 18-80 diagnosed with acute pancreatitis will be randomly assigned to receive either indomethacin or a placebo. The study aims to assess the impact of indomethacin on reducing complications and mortality rates associated with acute pancreatitis. The trial seeks to fill the gap in high-quality evidence regarding the use of NSAIDs in treating this condition.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce complications and mortality rates in patients with acute pancreatitis.
How similar studies have gone: While some preliminary studies have shown inconsistent results, the use of NSAIDs like indomethacin in treating acute pancreatitis remains largely untested in high-quality randomized controlled trials.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Peking University Sixth Hospital
Beijing, Beijing Municipality, China Recruiting -
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China Recruiting -
Liangxiang Hospital
Beijing, Beijing Municipality, China Recruiting -
Guiyang Second People's Hospital
Guiyang, Guizhou, China Recruiting -
Baoding Seventh Hospital
Baoding, Hebei, China Recruiting -
Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China Recruiting
Show 11 more locations
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Dengzhou People's Hospital
Dengzhou, Henan, China Recruiting -
Second People Hospital of Nanyang
Nanyang, Henan, China Recruiting -
The Second People's Hospital of Huai'an
Huaian, Jiangsu, China Recruiting -
Nantong First People's Hospital
Nantong, Jiangsu, China Recruiting -
Suqian People's Hospital
Suqian, Jiangsu, China Recruiting -
Wuxi Third People's Hospital
Wuxi, Jiangsu, China Recruiting -
Qinghai University Affiliated Hospital
Xining, Qinghai, China Recruiting -
West China Longquan Hospital Sichuan University
Chengdu, Sichuan, China Recruiting -
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China Recruiting -
Jinhua Municipal Central Hospital
Jinhua, Zhejiang, China Recruiting -
Lishui Municipal Central Hospital
Lishui, Zhejiang, China Recruiting
Study contacts
- Principal investigator: Zhitao Lu, M.D. — Baoding Seventh Hospital
- Study coordinator: Dong Wu, M.D.
- Email: dongwu@pumc.edu.cn
- Phone: 8618612671010
Similar studies
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Local complications of acute pancreatitis and postoperative pancreatic fistula: what happens in real life
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.