search
Back to results

A Trial of Indomethacin in Acute Pancreatitis

Primary Purpose

Acute Pancreatitis, Complication

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Indomethacin SR
Placebos
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pancreatitis focused on measuring Acute pancreatitis, Indomethacin, Prognosis, Organ dysfunction

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Indomethacin group

Standard group

Arm 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.

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.

Outcomes

Primary Outcome Measures

Occurence rate of organ dysfunction
Accumulation of varied organ dysfunction, especially the cardiovascular, renal and respiratory systems

Secondary Outcome Measures

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

Full Information

First Posted
May 24, 2018
Last Updated
December 12, 2018
Sponsor
Peking Union Medical College Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03547232
Brief Title
A Trial of Indomethacin in Acute Pancreatitis
Official Title
A Randomized Controlled Trial of Indomethacin in Acute Pancreatitis- Effectiveness and Safety
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
July 1, 2020 (Anticipated)
Study Completion Date
July 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pancreatitis, Complication
Keywords
Acute pancreatitis, Indomethacin, Prognosis, Organ dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Indomethacin group
Arm Type
Experimental
Arm 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.
Arm Title
Standard group
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Indomethacin SR
Other Intervention Name(s)
YINDUOMEIXIN
Intervention Description
Indomethacin SR 50mg given q12h from admission day 1 to day 7
Intervention Type
Drug
Intervention Name(s)
Placebos
Other Intervention Name(s)
sham
Intervention Description
Similar shape and size suppositories (Placebos) without indomethacin given q12h from admission day 1 to day 7
Primary Outcome Measure Information:
Title
Occurence rate of organ dysfunction
Description
Accumulation of varied organ dysfunction, especially the cardiovascular, renal and respiratory systems
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Occurence rate of pancreatic necrosis
Description
Accumulation of the key local complication of acute pancreatitis
Time Frame
1 month
Title
Incidence rate of ICU admission
Description
Evaluation of critical severe acute pancreatitis
Time Frame
1 month
Title
Mortality
Description
The number of deaths during a particular period of time
Time Frame
1 month
Other Pre-specified Outcome Measures:
Title
Hospitalization cost
Description
Expense of acute pancreatitis
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dong Wu, M.D.
Phone
8618612671010
Email
dongwu@pumc.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong Wu, M.D.
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong Wu, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25872171
Citation
Gorsky VA, Agapov MA, Khoreva MV, Leonenko IV. The effect of lornoxicam on TLR2 and TLR4 messenger RNA expression and tumor necrosis factor-alpha, interleukin-6, and interleukin-8 secretion in patients with systemic complications of acute pancreatitis. Pancreas. 2015 Jul;44(5):824-30. doi: 10.1097/MPA.0000000000000344.
Results Reference
result
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/?term=25872171
Description
A small sample study of NSAIDs for treatment of acute pancreatitis

Learn more about this trial

A Trial of Indomethacin in Acute Pancreatitis

We'll reach out to this number within 24 hrs