Rectal Indomethacin as Early Treatment for Acute Pancreatitis (INDOMAP Trial)
NCT ID: NCT03547232
Last Updated: 2025-06-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
1504 participants
INTERVENTIONAL
2024-12-01
2028-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
Indomethacin SR
Indomethacin SR 50mg given q12h from admission day 1 to day 7
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.
Placebos
Similar shape and size suppositories (Placebos) without indomethacin given q12h from admission day 1 to day 7
Interventions
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Indomethacin SR
Indomethacin SR 50mg given q12h from admission day 1 to day 7
Placebos
Similar shape and size suppositories (Placebos) without indomethacin given q12h from admission day 1 to day 7
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Responsible Party
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DONG WU
Professor of Gastroenterology
Principal Investigators
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Dong Wu, M.D.
Role: STUDY_CHAIR
Peking Union Medical College Hospital
Zhitao Lu, M.D.
Role: PRINCIPAL_INVESTIGATOR
Baoding Seventh Hospital
Yanfeng Wang, M.D.
Role: PRINCIPAL_INVESTIGATOR
Liangxiang Hospital
Shanshan Yu, M.D.
Role: PRINCIPAL_INVESTIGATOR
Guiyang Second People's Hospital
Na Wu, M.D.
Role: PRINCIPAL_INVESTIGATOR
Dengzhou People's Hospital
Mei Liu, M.D.
Role: PRINCIPAL_INVESTIGATOR
Affiliated Hospital of Qinghai University
Xiao Fan, M.D.
Role: PRINCIPAL_INVESTIGATOR
Second People Hospital of Nanyang
Zuoyan Wu, MD
Role: PRINCIPAL_INVESTIGATOR
Peking University Sixth Hospital
Ruifeng Wang, MD
Role: PRINCIPAL_INVESTIGATOR
Harbin Medical University
Baofeng Zhu, MD
Role: PRINCIPAL_INVESTIGATOR
Nantong First People's Hospital
Yan Shi, MD
Role: PRINCIPAL_INVESTIGATOR
The Second People's Hospital of Huai'an
Ming Sun, MD
Role: PRINCIPAL_INVESTIGATOR
Suqian People's Hospital
Wei Huang, MD
Role: PRINCIPAL_INVESTIGATOR
Wuxi Third People's Hospital
Shicheng Zheng, MD
Role: PRINCIPAL_INVESTIGATOR
West China Longquan Hospital Sichuan University
Jianzhong Yang, MD
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital of Xinjiang Medical University
Daoyuan Jing, MD
Role: PRINCIPAL_INVESTIGATOR
Jinhua Municipal Central Hospital
Hong Liu, MD
Role: PRINCIPAL_INVESTIGATOR
Lishui Municipal Central Hospital
Locations
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Peking University Sixth Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Liangxiang Hospital
Beijing, Beijing Municipality, China
Guiyang Second People's Hospital
Guiyang, Guizhou, China
Baoding Seventh Hospital
Baoding, Hebei, China
Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Dengzhou People's Hospital
Dengzhou, Henan, China
Second People Hospital of Nanyang
Nanyang, Henan, China
The Second People's Hospital of Huai'an
Huaian, Jiangsu, China
Nantong First People's Hospital
Nantong, Jiangsu, China
Suqian People's Hospital
Suqian, Jiangsu, China
Wuxi Third People's Hospital
Wuxi, Jiangsu, China
Qinghai University Affiliated Hospital
Xining, Qinghai, China
West China Longquan Hospital Sichuan University
Chengdu, Sichuan, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
Jinhua Municipal Central Hospital
Jinhua, Zhejiang, China
Lishui Municipal Central Hospital
Lishui, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Zuoyan Wu, MD
Role: primary
Dong Wu, M.D.
Role: primary
Yanfeng Wang, M.D.
Role: primary
Shanshan Yu, M.D.
Role: primary
Zhitao Lu, M.D.
Role: primary
Ruifeng Wang, MD
Role: primary
Na Wu, M.D.
Role: primary
Xiao Fan, M.D.
Role: primary
Yan Shi, MD
Role: primary
Baofeng Zhu, MD
Role: primary
Ming Sun, MD
Role: primary
Wei Huang, MD
Role: primary
Mei Liu, M.D.
Role: primary
Shicheng Zheng, MD
Role: primary
Jianzhong Yang, MD
Role: primary
Daoyuan Jing, MD
Role: primary
Hong Liu, MD
Role: primary
References
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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.
Related Links
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A small sample study of NSAIDs for treatment of acute pancreatitis
Other Identifiers
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I-23PJ1671
Identifier Type: -
Identifier Source: org_study_id
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