Rectal Indomethacin as Early Treatment for Acute Pancreatitis (INDOMAP Trial) (NCT03547232) | Clinical Trial Compass
RecruitingPhase 4
Rectal Indomethacin as Early Treatment for Acute Pancreatitis (INDOMAP Trial)
China1,504 participantsStarted 2024-12-01
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Occurence rate of organ dysfunction caused by acute pancreatitis