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

NCT03547232 | Recruiting Phase 4 DMC

• 1 other identifier: I-23PJ1671
• Study Type: interventional
• Target: 1,504
• Locations: 1 country
• Sites: 17

Brief 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. 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.

Conditions

Acute Pancreatitis; Complication; Mortality Rate; Organ Failure, Multiple

Keywords

Acute pancreatitis; Indomethacin; Prognosis; Organ dysfunction

Outcome Measures

Primary Outcomes (1)

• Occurence rate of organ dysfunction caused by acute pancreatitis

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

  1 week

Secondary Outcomes (3)

• Occurence rate of pancreatic necrosis

  1 month

• Incidence rate of ICU admission

  1 month

• Mortality

  1 month

Other Outcomes (1)

• Hospitalization cost

  1 month

Study Arms (2)

Indomethacin group

EXPERIMENTAL

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

Standard group

SHAM COMPARATOR

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

Interventions

Indomethacin SR DRUG

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

Also known as: YINDUOMEIXIN

Indomethacin group

Placebos DRUG

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

Also known as: SHAM

Standard group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (17)

Peking University Sixth Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Liangxiang Hospital

Beijing, Beijing Municipality, 102401, China

RECRUITING

Guiyang Second People's Hospital

Guiyang, Guizhou, 550005, China

RECRUITING

Baoding Seventh Hospital

Baoding, Hebei, 071000, China

RECRUITING

Fourth Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150001, China

RECRUITING

Dengzhou People's Hospital

Dengzhou, Henan, 411381, China

RECRUITING

Second People Hospital of Nanyang

Nanyang, Henan, 473012, China

RECRUITING

The Second People's Hospital of Huai'an

Huaian, Jiangsu, 223300, China

RECRUITING

Nantong First People's Hospital

Nantong, Jiangsu, 226001, China

RECRUITING

Suqian People's Hospital

Suqian, Jiangsu, 223800, China

RECRUITING

Wuxi Third People's Hospital

Wuxi, Jiangsu, 214043, China

RECRUITING

Qinghai University Affiliated Hospital

Xining, Qinghai, 810001, China

RECRUITING

West China Longquan Hospital Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830054, China

RECRUITING

Jinhua Municipal Central Hospital

Jinhua, Zhejiang, 321000, China

RECRUITING

Lishui Municipal Central Hospital

Lishui, Zhejiang, 323000, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 25872171 BACKGROUND

Related Links

• A small sample study of NSAIDs for treatment of acute pancreatitis

MeSH Terms

Conditions

Pancreatitis; Multiple Organ Failure

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Shock; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dong Wu, M.D.

  Peking Union Medical College Hospital

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong Wu, M.D.

CONTACT

8618612671010; dongwu@pumc.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Gastroenterology

Study Record Dates

• First Submitted: May 24, 2018
• First Posted: June 6, 2018
• Study Start: December 1, 2024
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (17)