Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03547232

Rectal Indomethacin as Early Treatment for Acute Pancreatitis (INDOMAP 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Acute Pancreatitis Complication Digestive System Diseases Mortality Rate Multiple Organ Failure Organ Failure, Multiple Pancreatic Diseases Pancreatitis Pathologic Processes Pathological Conditions, Signs and Symptoms Shock

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Liangxiang Hospital, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Indomethacin SR

Drug

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

Other names: YINDUOMEIXIN

Placebos

Drug

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

Other names: SHAM

Primary outcomes

  1. Occurence rate of organ dysfunction caused by acute pancreatitis

    Time frame: 1 week

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

Secondary outcomes

  1. Occurence rate of pancreatic necrosis

    Time frame: 1 month

    Accumulation of the key local complication of acute pancreatitis

  2. Incidence rate of ICU admission

    Time frame: 1 month

    Evaluation of critical severe acute pancreatitis

  3. Mortality

    Time frame: 1 month

    The number of deaths during a particular period of time

Other outcomes

  1. Hospitalization cost

    Time frame: 1 month

    Expense of acute pancreatitis

Study contacts

Contact information is provided by the study sponsor or research team.

Dong Wu, M.D.

CONTACT

[email protected]

8618612671010

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

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

Acronym: INDOMAP

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jun 6, 2018
Registry last updated
Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.