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Acute PancreatitisPhase 4INDOMAPNCT03547232

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

A Phase 4 study testing Indomethacin SR in people with Acute Pancreatitis and Complication, run by Peking Union Medical College Hospital at 17 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Acute Pancreatitis, Complication, Mortality Rate
What is being tested?
Indomethacin SR
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,504 participants
Where
17 sitesChina
Study dates
1 Dec 2024to 1 Dec 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

17 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Dong Wu, M.D. contact

8618612671010

dongwu@pumc.edu.cn

17 sites in 1 country

China17 sites, 17 recruiting

  • Baoding Seventh Hospital

    Baoding, Hebei, 071000

    Zhitao Lu, M.D.

    Recruiting

  • Peking University Sixth Hospital

    Beijing, Beijing Municipality, 100191

    Zuoyan Wu, MD

    Recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

    Dong Wu, M.D.

    Recruiting

  • Liangxiang Hospital

    Beijing, Beijing Municipality, 102401

    Yanfeng Wang, M.D.

    Recruiting

  • West China Longquan Hospital Sichuan University

    Chengdu, Sichuan, 610041

    Shicheng Zheng, MD

    Recruiting

  • Dengzhou People's Hospital

    Dengzhou, Henan, 411381

    Na Wu, M.D.

    Recruiting

  • Guiyang Second People's Hospital

    Guiyang, Guizhou, 550005

    Shanshan Yu, M.D.

    Recruiting

  • Fourth Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001

    Ruifeng Wang, MD

    Recruiting

  • The Second People's Hospital of Huai'an

    Huaian, Jiangsu, 223300

    Yan Shi, MD

    Recruiting

  • Jinhua Municipal Central Hospital

    Jinhua, Zhejiang, 321000

    Daoyuan Jing, MD

    Recruiting

  • Lishui Municipal Central Hospital

    Lishui, Zhejiang, 323000

    Hong Liu, MD

    Recruiting

  • Nantong First People's Hospital

    Nantong, Jiangsu, 226001

    Baofeng Zhu, MD

    Recruiting

  • Second People Hospital of Nanyang

    Nanyang, Henan, 473012

    Xiao Fan, M.D.

    Recruiting

  • Suqian People's Hospital

    Suqian, Jiangsu, 223800

    Ming Sun, MD

    Recruiting

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830054

    Jianzhong Yang, MD

    Recruiting

  • Wuxi Third People's Hospital

    Wuxi, Jiangsu, 214043

    Wei Huang, MD

    Recruiting

  • Qinghai University Affiliated Hospital

    Xining, Qinghai, 810001

    Mei Liu, M.D.

    Recruiting

Other trials in China

About this study

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

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.

Being tested
Indomethacin SR, Placebos
Keywords
Acute pancreatitis, Indomethacin, Prognosis, Organ dysfunction
Medical subject headings
Pancreatitis, Multiple Organ Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Indomethacin SRDrug

    Also called YINDUOMEIXIN

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

  • PlacebosDrug

    Also called SHAM

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

Study groups in NCT03547232
Study groupRoleWhat they receive
Indomethacin groupExperimentalIndomethacin SR 50mg q12h from day1 to day 7 plus standard treatment for acute pancreatitis including adequate intravenous fluids, analgesics and early enteral nutrition support if possible.
Receives: Drug: Indomethacin SR
Standard groupSham comparatorSimilar shape and size suppositories without indomethacin (Placebos) given q12h from admission day 1 to day 7, plus standard treatment for acute pancreatitis including adequate intravenous fluids, analgesics and early enteral nutrition support if possible.
Receives: Drug: Placebos

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurence rate of organ dysfunction caused by acute pancreatitis

    Accumulation of varied organ dysfunction, especially the cardiovascular, renal and respiratory systems

    Measured: 1 week

Secondary outcomes (3)

  1. Occurence rate of pancreatic necrosis

    Accumulation of the key local complication of acute pancreatitis

    Measured: 1 month

  2. Incidence rate of ICU admission

    Evaluation of critical severe acute pancreatitis

    Measured: 1 month

  3. Mortality

    The number of deaths during a particular period of time

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2018
  2. Study start1 Dec 2024
  3. Primary completion1 Jun 2028 (estimated)
  4. Study completion1 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,504 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03547232
Sponsor's protocol ID
I-23PJ1671
Acronym
INDOMAP
Status last verified
Jun 2025
First submitted
24 May 2018
Last updated
15 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gorsky VA, Agapov MA, Khoreva MV, Leonenko IV. The effect of lornoxicam on TLR2 and TLR4 messenger RNA expression and tumor necrosis factor-alpha, interleukin-6, and interleukin-8 secretion in patients with systemic complications of acute pancreatitis. Pancreas. 2015 Jul;44(5):824-30. doi: 10.1097/MPA.0000000000000344.

    PubMed 25872171

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Indomethacin SR in people with Acute Pancreatitis and Complication, run by Peking Union Medical College Hospital at 17 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dong Wu, M.D. (8618612671010, dongwu@pumc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurence rate of organ dysfunction caused by acute pancreatitis (time frame: 1 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03547232, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.

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