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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Enrolling; Phase 4

Conditions: Complication; Organ Failure, Multiple; Acute Pancreatitis; Mortality Rate

Treatments: Drug: Placebos; Drug: Indomethacin SR

Study type: Interventional

Funder types: Other

Identifiers

NCT03547232

I-23PJ1671

Details and patient eligibility

About

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.

Enrollment: 1,428 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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 study enrollment.

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,428 participants in 2 patient groups

Indomethacin group

Experimental group

Description:

Indomethacin SR 50mg q12h from day1 to day 7 plus standard treatment for acute pancreatitis including adequate intravenous fluids, analgesics and early enteral nutrition support if possible.

Treatment:

Drug: Indomethacin SR

Standard group

Sham Comparator group

Description:

Similar shape and size suppositories without indomethacin (Placebos) given q12h from admission day 1 to day 7, plus standard treatment for acute pancreatitis including adequate intravenous fluids, analgesics and early enteral nutrition support if possible.

Treatment:

Drug: Placebos