A Trial of Indomethacin in Acute Pancreatitis

Sponsor

Peking Union Medical College Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03547232

Collaborator

(none)

240

Enrollment

Location

Arms

Anticipated Duration (Months)

9.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Pancreatitis Complication	Drug: Indomethacin SR Drug: Placebos	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

A Randomized Controlled Trial of Indomethacin in Acute Pancreatitis- Effectiveness and Safety

Actual Study Start Date :

Jul 1, 2018

Anticipated Primary Completion Date :

Jul 1, 2020

Anticipated Study Completion Date :

Jul 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Indomethacin group 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.	Drug: Indomethacin SR Indomethacin SR 50mg given q12h from admission day 1 to day 7 Other Names: YINDUOMEIXIN
Sham Comparator: Standard group 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.	Drug: Placebos Similar shape and size suppositories (Placebos) without indomethacin given q12h from admission day 1 to day 7 Other Names: sham

Arm

Intervention/Treatment

Experimental: Indomethacin group

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.

Drug: Indomethacin SR

Indomethacin SR 50mg given q12h from admission day 1 to day 7

Other Names:

YINDUOMEIXIN

Sham Comparator: Standard group

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.

Drug: Placebos

Similar shape and size suppositories (Placebos) without indomethacin given q12h from admission day 1 to day 7

Other Names:

sham

Outcome Measures

Primary Outcome Measures

Occurence rate of organ dysfunction [1 week]
Accumulation of varied organ dysfunction, especially the cardiovascular, renal and respiratory systems

Secondary Outcome Measures

Occurence rate of pancreatic necrosis [1 month]
Accumulation of the key local complication of acute pancreatitis
Incidence rate of ICU admission [1 month]
Evaluation of critical severe acute pancreatitis
Mortality [1 month]
The number of deaths during a particular period of time

Other Outcome Measures

Hospitalization cost [1 month]
Expense of acute pancreatitis

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

All patients ages 18-75 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