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

June 11, 2025 updated by: DONG WU, Peking Union Medical College Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1504

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
          • Dong Wu, M.D.
      • Beijing, Beijing, China, 100191
        • Recruiting
        • Peking University Sixth Hospital
        • Contact:
          • Zuoyan Wu, MD
      • Beijing, Beijing, China, 102401
        • Recruiting
        • Liangxiang Hospital
        • Contact:
          • Yanfeng Wang, M.D.
    • Guizhou
      • Guiyang, Guizhou, China, 550005
        • Recruiting
        • Guiyang Second People's Hospital
        • Contact:
          • Shanshan Yu, M.D.
    • Hebei
      • Baoding, Hebei, China, 071000
        • Recruiting
        • Baoding Seventh Hospital
        • Contact:
          • Zhitao Lu, M.D.
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150001
        • Recruiting
        • Fourth Affiliated Hospital of Harbin Medical University
        • Contact:
          • Ruifeng Wang, MD
    • Henan
      • Dengzhou, Henan, China, 411381
        • Recruiting
        • Dengzhou People's Hospital
        • Contact:
          • Na Wu, M.D.
      • Nanyang, Henan, China, 473012
        • Recruiting
        • Second People Hospital of Nanyang
        • Contact:
          • Xiao Fan, M.D.
    • Jiangsu
      • Huaian, Jiangsu, China, 223300
        • Recruiting
        • The Second People's Hospital of Huai'an
        • Contact:
          • Yan Shi, MD
      • Nantong, Jiangsu, China, 226001
        • Recruiting
        • Nantong First People's Hospital
        • Contact:
          • Baofeng Zhu, MD
      • Suqian, Jiangsu, China, 223800
        • Recruiting
        • Suqian People's Hospital
        • Contact:
          • Ming Sun, MD
      • Wuxi, Jiangsu, China, 214043
        • Recruiting
        • Wuxi Third People's Hospital
        • Contact:
          • Wei Huang, MD
    • Qinghai
      • Xining, Qinghai, China, 810001
        • Recruiting
        • Qinghai University Affiliated Hospital
        • Contact:
          • Mei Liu, M.D.
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Longquan Hospital Sichuan University
        • Contact:
          • Shicheng Zheng, MD
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830054
        • Recruiting
        • The First Affiliated Hospital of Xinjiang Medical University
        • Contact:
          • Jianzhong Yang, MD
    • Zhejiang
      • Jinhua, Zhejiang, China, 321000
        • Recruiting
        • Jinhua Municipal Central Hospital
        • Contact:
          • Daoyuan Jing, MD
      • Lishui, Zhejiang, China, 323000
        • Recruiting
        • Lishui Municipal Central Hospital
        • Contact:
          • Hong Liu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Indomethacin group
Indomethacin 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.
Drug: Indomethacin SR
Indomethacin SR 50mg given q12h from admission day 1 to day 7
Other Names:
  • YINDUOMEIXIN
Sham Comparator: Standard group
Similar 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.
Drug: Placebos
Similar shape and size suppositories (Placebos) without indomethacin given q12h from admission day 1 to day 7
Other Names:
  • SHAM

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
1 week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Occurence rate of pancreatic necrosis
Time Frame: 1 month
Accumulation of the key local complication of acute pancreatitis
1 month
Incidence rate of ICU admission
Time Frame: 1 month
Evaluation of critical severe acute pancreatitis
1 month
Mortality
Time Frame: 1 month
The number of deaths during a particular period of time
1 month

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hospitalization cost
Time Frame: 1 month
Expense of acute pancreatitis
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking Union Medical College Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Dong Wu, M.D., Peking Union Medical College Hospital
  • Principal Investigator: Zhitao Lu, M.D., Baoding Seventh Hospital
  • Principal Investigator: Yanfeng Wang, M.D., Liangxiang Hospital
  • Principal Investigator: Shanshan Yu, M.D., Guiyang Second People's Hospital
  • Principal Investigator: Na Wu, M.D., Dengzhou People's Hospital
  • Principal Investigator: Mei Liu, M.D., Affiliated Hospital of Qinghai University
  • Principal Investigator: Xiao Fan, M.D., Second People Hospital of Nanyang
  • Principal Investigator: Zuoyan Wu, MD, Peking University Sixth Hospital
  • Principal Investigator: Ruifeng Wang, MD, Harbin Medical University
  • Principal Investigator: Baofeng Zhu, MD, Nantong First People's Hospital
  • Principal Investigator: Yan Shi, MD, The Second People's Hospital of Huai'an
  • Principal Investigator: Ming Sun, MD, Suqian People's Hospital
  • Principal Investigator: Wei Huang, MD, Wuxi Third People's Hospital
  • Principal Investigator: Shicheng Zheng, MD, West China Longquan Hospital Sichuan University
  • Principal Investigator: Jianzhong Yang, MD, First Affiliated Hospital of Xinjiang Medical University
  • Principal Investigator: Daoyuan Jing, MD, Jinhua Municipal Central Hospital
  • Principal Investigator: Hong Liu, MD, Lishui Municipal Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 24, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 6, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • I-23PJ1671

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings