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

Last updated: June 2, 2024
Sponsor: Peking Union Medical College Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Pancreatitis

Treatment

Placebos

Indomethacin SR

Clinical Study ID

NCT03547232
I-23PJ1671
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All patients ages 18-80 years admitted to Peking Union Medical College Hospital (PUMCH) 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 studyenrollment.

Exclusion

Exclusion Criteria:

  • Onset time >48 hours

  • Presence of renal dysfunction (serum creatinine > 1.5 *normal upper limit)

  • Active peptic ulcer disease or GI bleeding

  • Pregnancy or breast-feeding

  • Use of daily antiplatelet or anticoagulant drug(s) within 2 week of presentation

  • 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

Study Design

Total Participants: 1428
Treatment Group(s): 2
Primary Treatment: Placebos
Phase: 4
Study Start date:
June 01, 2024
Estimated Completion Date:
June 01, 2030

Connect with a study center

  • Liangxiang Hospital

    Beijing, Beijing 102401
    China

    Active - Recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijing 100730
    China

    Active - Recruiting

  • Peking University Sixth Hospital

    Beijing, Beijing 100191
    China

    Active - Recruiting

  • Guiyang Second People's Hospital

    Guiyang, Guizhou 550005
    China

    Active - Recruiting

  • Baoding Seventh Hospital

    Baoding, Hebei 071000
    China

    Active - Recruiting

  • Fourth Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang 150001
    China

    Active - Recruiting

  • Dengzhou People's Hospital

    Dengzhou, Henan 411381
    China

    Active - Recruiting

  • Second People Hospital of Nanyang

    Nanyang, Henan 473012
    China

    Active - Recruiting

  • The Second People's Hospital of Huai'an

    Huaian, Jiangsu 223300
    China

    Active - Recruiting

  • Nantong First People's Hospital

    Nantong, Jiangsu 226001
    China

    Active - Recruiting

  • Suqian People's Hospital

    Suqian, Jiangsu 223800
    China

    Active - Recruiting

  • Wuxi Third People's Hospital

    Wuxi, Jiangsu 214043
    China

    Active - Recruiting

  • Qinghai University Affiliated Hospital

    Xining, Qinghai 810001
    China

    Active - Recruiting

  • West China Longquan Hospital Sichuan University

    Chengdu, Sichuan 610041
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang 830054
    China

    Active - Recruiting

  • Jinhua Municipal Central Hospital

    Jinhua, Zhejiang 321000
    China

    Active - Recruiting

  • Lishui Municipal Central Hospital

    Lishui, Zhejiang 323000
    China

    Active - Recruiting

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