NCT03547232 Rectal Indomethacin as Early Treatment for Acute Pancreatitis (INDOMAP Trial)
| NCT ID | NCT03547232 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Peking Union Medical College Hospital |
| Condition | Acute Pancreatitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,504 participants |
| Start Date | 2024-12-01 |
| Primary Completion | 2028-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 1,504 participants in total. It began in 2024-12-01 with a primary completion date of 2028-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Dong Wu, M.D.
STUDY CHAIR
Peking Union Medical College Hospital
Frequently Asked Questions
Who can join the NCT03547232 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Acute Pancreatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03547232 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT03547232 currently recruiting?
Yes, NCT03547232 is actively recruiting participants. Contact the research team at dongwu@pumc.edu.cn for enrollment information.
Where is the NCT03547232 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China, Beijing, China, Guiyang, China and 11 additional locations.
Who is sponsoring the NCT03547232 clinical trial?
NCT03547232 is sponsored by Peking Union Medical College Hospital. The principal investigator is Dong Wu, M.D. at Peking Union Medical College Hospital. The trial plans to enroll 1,504 participants.