Using Indomethacin to Treat Acute Pancreatitis
Rectal Indomethacin as Early Treatment for Acute Pancreatitis (INDOMAP Trial): Study Protocol for a Multi-center, Double-blinded, Placebo-controlled, Randomized Clinical Trial
This study is testing if giving indomethacin through the rectum can help people with acute pancreatitis have fewer complications and live longer.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 1504 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Locations | 17 sites (Beijing, Beijing Municipality and 16 other locations) |
| Trial ID | NCT03547232 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effectiveness of rectal indomethacin as an early treatment for acute pancreatitis, a condition characterized by inflammation of the pancreas. Patients aged 18-80 diagnosed with acute pancreatitis will be randomly assigned to receive either indomethacin or a placebo. The study aims to assess the impact of indomethacin on reducing complications and mortality rates associated with acute pancreatitis. The trial seeks to fill the gap in high-quality evidence regarding the use of NSAIDs in treating this condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 who have been diagnosed with acute pancreatitis based on specific clinical criteria.
Not a fit: Patients with renal dysfunction, active peptic ulcer disease, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce complications and mortality rates in patients with acute pancreatitis.
How similar studies have performed: While some preliminary studies have shown inconsistent results, the use of NSAIDs like indomethacin in treating acute pancreatitis remains largely untested in high-quality randomized controlled trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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. Exclusion Criteria: * 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
Where this trial is running
Beijing, Beijing Municipality and 16 other locations
- Peking University Sixth Hospital — Beijing, Beijing Municipality, China (Recruiting)
- Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)
- Liangxiang Hospital — Beijing, Beijing Municipality, China (Recruiting)
- Guiyang Second People's Hospital — Guiyang, Guizhou, China (Recruiting)
- Baoding Seventh Hospital — Baoding, Hebei, China (Recruiting)
- Fourth Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang, China (Recruiting)
- Dengzhou People's Hospital — Dengzhou, Henan, China (Recruiting)
- Second People Hospital of Nanyang — Nanyang, Henan, China (Recruiting)
- The Second People's Hospital of Huai'an — Huaian, Jiangsu, China (Recruiting)
- Nantong First People's Hospital — Nantong, Jiangsu, China (Recruiting)
- Suqian People's Hospital — Suqian, Jiangsu, China (Recruiting)
- Wuxi Third People's Hospital — Wuxi, Jiangsu, China (Recruiting)
- Qinghai University Affiliated Hospital — Xining, Qinghai, China (Recruiting)
- West China Longquan Hospital Sichuan University — Chengdu, Sichuan, China (Recruiting)
- The First Affiliated Hospital of Xinjiang Medical University — Ürümqi, Xinjiang, China (Recruiting)
- Jinhua Municipal Central Hospital — Jinhua, Zhejiang, China (Recruiting)
- Lishui Municipal Central Hospital — Lishui, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Zhitao Lu, M.D. — Baoding Seventh Hospital
- Study coordinator: Dong Wu, M.D.
- Email: dongwu@pumc.edu.cn
- Phone: 8618612671010
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.