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

Acute Pancreatitis Clinical Trial

— INDOMAP  

Official title:

Rectal Indomethacin as Early Treatment for Acute Pancreatitis (INDOMAP Trial): Study Protocol for a Multi-center, Double-blinded, Placebo-controlled, Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03547232
• Other study ID #: I-23PJ1671
• Status: Recruiting
• Phase: Phase 4
• Start date: June 1, 2024
• Est. completion date: June 1, 2030

Study information

• Verified date: June 2024
• Source: Peking Union Medical College Hospital
• Contact: Dong Wu, M.D.
• Phone: 8618612671010
• Email: dongwu[@]pumc.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1428
• Est. completion date: June 1, 2030
• Est. primary completion date: June 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pancreatitis
• Complication
• Mortality Rate
• Multiple Organ Failure
• Organ Failure, Multiple
• Pancreatitis

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	Baoding Seventh Hospital	Baoding	Hebei
China	Liangxiang Hospital	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Peking University Sixth Hospital	Beijing	Beijing
China	West China Longquan Hospital Sichuan University	Chengdu	Sichuan
China	Dengzhou People's Hospital	Dengzhou	Henan
China	Guiyang Second People's Hospital	Guiyang	Guizhou
China	Fourth Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	The Second People's Hospital of Huai'an	Huaian	Jiangsu
China	Jinhua Municipal Central Hospital	Jinhua	Zhejiang
China	Lishui Municipal Central Hospital	Lishui	Zhejiang
China	Nantong First People's Hospital	Nantong	Jiangsu
China	Second People Hospital of Nanyang	Nanyang	Henan
China	Suqian People's Hospital	Suqian	Jiangsu
China	The First Affiliated Hospital of Xinjiang Medical University	Ürümqi	Xinjiang
China	Wuxi Third People's Hospital	Wuxi	Jiangsu
China	Qinghai University Affiliated Hospital	Xining	Qinghai

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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. Pa — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hospitalization cost	Expense of acute pancreatitis	1 month
Primary	Occurence rate of organ dysfunction	Accumulation of varied organ dysfunction, especially the cardiovascular, renal and respiratory systems	1 week
Secondary	Occurence rate of pancreatic necrosis	Accumulation of the key local complication of acute pancreatitis	1 month
Secondary	Incidence rate of ICU admission	Evaluation of critical severe acute pancreatitis	1 month
Secondary	Mortality	The number of deaths during a particular period of time	1 month

External Links

•   A small sample study of NSAIDs for treatment of acute pancreatitis