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Recruiting NCT03547232

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

Phase IV Interventional Acute Pancreatitis Complication Mortality Rate Organ Failure, Multiple

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Indomethacin SR, Placebos.
Who it may be relevant to
Registry conditions: Acute Pancreatitis, Complication, Mortality Rate, Organ Failure, Multiple. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Indomethacin SR
    Indomethacin SR 50mg given q12h from admission day 1 to day 7
  • Drug Placebos
    Similar shape and size suppositories (Placebos) without indomethacin given q12h from admission day 1 to day 7

Primary outcome measures

  • Occurence rate of organ dysfunction caused by acute pancreatitis [Time frame: 1 week]
Secondary outcome measures (3)
  • Occurence rate of pancreatic necrosis [Time frame: 1 month]
  • Incidence rate of ICU admission [Time frame: 1 month]
  • Mortality [Time frame: 1 month]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 17 centers
  • Peking University Sixth Hospital — Beijing
  • Peking Union Medical College Hospital — Beijing
  • Liangxiang Hospital — Beijing
  • Guiyang Second People's Hospital — Guiyang
  • Baoding Seventh Hospital — Baoding
  • Fourth Affiliated Hospital of Harbin Medical University — Harbin
  • Dengzhou People's Hospital — Dengzhou
  • Second People Hospital of Nanyang — Nanyang
  • … and 9 more centers

Publications

  • 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

Identifiers

NCT: NCT03547232 · I-23PJ1671

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗