Clinical trial Recruiting at 17 sites Phase 4 Interventional Ages 18 to 80

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

PhasePhase 4
Study typeInterventional
Ages18 Years to 80 Years
SexAll
Enrollment1504 (estimated)
SponsorPeking Union Medical College Hospital
Academic / other
Locations17 sites (Beijing, Beijing Municipality and 16 other locations)
StatusRecruiting
StartedDecember 1, 2024
Main results expectedJune 1, 2028
Study endsDecember 1, 2028
Registry record updatedJune 15, 2025
Trial IDNCT03547232 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.