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New treatment option for Acute Pancreatitis
Official title Rectal Indomethacin as Early Treatment for Acute Pancreatitis (INDOMAP Trial)
ClinicalTrials.gov ID: NCT03547232
What this study is testing
What is Indomethacin SR?
Indomethacin SR is an investigational medicine, being studied as a potential treatment for acute pancreatitis.
Also referred to as YINDUOMEIXIN.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- All patients ages 18-80 years 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.
You likely can't join if
- Onset time \>24 hours
- 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
See the full eligibility criteria
- All patients ages 18-80 years 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.
- Onset time \>24 hours
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Guiyang, Guizhou, China
- Baoding, Hebei, China
- Harbin, Heilongjiang, China
- Dengzhou, Henan, China
- Nanyang, Henan, China
- Huaian, Jiangsu, China
- Nantong, Jiangsu, China
- Suqian, Jiangsu, China
- Wuxi, Jiangsu, China
- Xining, Qinghai, China
- Chengdu, Sichuan, China
- Ürümqi, Xinjiang, China
- Jinhua, Zhejiang, China
- Lishui, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Guiyang, Guizhou, China; Baoding, Hebei, China; Harbin, Heilongjiang, China; Dengzhou, Henan, China; Nanyang, Henan, China and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.