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

RecruitingPhase 4Ages 18 Years - 80 YearsAllPeking Union Medical College Hospital
NCT03547232 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Indomethacin SR
  • Placebos
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Where

17 sites
Peking University Sixth Hospital
Beijing, China
Peking Union Medical College Hospital
Beijing, China
Liangxiang Hospital
Beijing, China
Guiyang Second People's Hospital
Guiyang, China
Baoding Seventh Hospital
Baoding, China
Fourth Affiliated Hospital of Harbin Medical University
Harbin, China
Dengzhou People's Hospital
Dengzhou, China
Second People Hospital of Nanyang
Nanyang, China

…and 9 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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