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A Trial of Indomethacin in Acute Pancreatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03547232
Recruitment Status : Unknown
Verified December 2018 by DONG WU, Peking Union Medical College Hospital.
Recruitment status was:  Recruiting
First Posted : June 6, 2018
Last Update Posted : December 14, 2018
Sponsor:
Information provided by (Responsible Party):
DONG WU, Peking Union Medical College Hospital

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 1, 2018
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Arms and Interventions
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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 Name: 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 Name: sham


Outcome Measures
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Primary Outcome Measures :
  1. Occurence rate of organ dysfunction [ Time Frame: 1 week ]
    Accumulation of varied organ dysfunction, especially the cardiovascular, renal and respiratory systems


Secondary Outcome Measures :
  1. Occurence rate of pancreatic necrosis [ Time Frame: 1 month ]
    Accumulation of the key local complication of acute pancreatitis

  2. Incidence rate of ICU admission [ Time Frame: 1 month ]
    Evaluation of critical severe acute pancreatitis

  3. Mortality [ Time Frame: 1 month ]
    The number of deaths during a particular period of time


Other Outcome Measures:
  1. Hospitalization cost [ Time Frame: 1 month ]
    Expense of acute pancreatitis


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03547232


Contacts
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Contact: Dong Wu, M.D. 8618612671010 dongwu@pumc.edu.cn

Locations
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China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Dong Wu, M.D.         
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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Principal Investigator: Dong Wu, M.D. Peking Union Medical College Hospital
More Information
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Additional Information:

Publications of Results:

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Responsible Party: DONG WU, Associate Professor of Gastroenterology, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03547232    
Other Study ID Numbers: ZS-1413
First Posted: June 6, 2018    Key Record Dates
Last Update Posted: December 14, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by DONG WU, Peking Union Medical College Hospital:
Acute pancreatitis
Indomethacin
Prognosis
Organ dysfunction
Additional relevant MeSH terms:
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Pancreatitis
Pancreatic Diseases
Digestive System Diseases
Indomethacin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Tocolytic Agents
Reproductive Control Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action