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RECRUITING
NCT03547232
PHASE4

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

Sponsor: Peking Union Medical College Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

1504

Start Date

2024-12-01

Completion Date

2028-12-01

Last Updated

2025-06-15

Healthy Volunteers

No

Interventions

DRUG

Indomethacin SR

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

DRUG

Placebos

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

Locations (17)

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