An interventional study of Indomethacin 100 MG and Diclofenac 100mg in ERCP, Pancreatitis and Non-steroidal Anti-inflammatory (NSAID), sponsored by Air Force Military Medical University, China. Recruiting at 20 sites in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-06-15.
Sponsored by Air Force Military Medical University, China · Not applicable, Interventional, and Prevention
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Among 20 studies testing indomethacin in Pancreatitis — 6 open to participants now, 6 under way, 1 of them phase 3. Indomethacin · Pancreatitis.
Among the 20 studies testing indomethacin in Pancreatitis, this one has the largest planned enrollment, is one of 2 that started in 2025, is one of 6 with no phase, and was the 17th registered.
558 studies on the registry are indexed under Pancreatitis; 165 are open to participants now.
Browse Pancreatitis studies →6 of the 20 studies testing indomethacin in Pancreatitis are open now, in 5 countries. Recruiting first, the newest first:
Changhai Hospital · Sites in China
Ages 18+
Peking Union Medical College Hospital · Sites in China
Ages 18–80
Moti Lal Nehru Medical College · Sites in India
Ages 18–65
Chinese University of Hong Kong · Sites in China, Hong Kong, Thailand
Ages 18–99
University of California, San Francisco · Sites in United States
Ages 18+
By country, each count listing its studies:
Indomethacin: first FDA approval 1965 (INDOCIN). What it is approved for, and how studies give it, is on its page →
Of the 112 Pancreatitis studies recruiting now, 62 (55%) set no upper age limit and 27 (24%) stop at 75 or younger; 14 take children under 18; 12 take healthy volunteers.
This study: 18 Years to 90 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
20 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 1 · Phase 3 7 · Phase 4 7
First in 2005; this study’s year is marked. 2 started in 2025.
This study's planned enrollment of 4,050 is above the median of 100 across 349 interventional studies indexed under Pancreatitis.
Median enrollment 492 across the 20 interventional studies. Of the 12 that completed or were terminated, 8 (67%) have results posted.
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None of the 20 has an industry lead sponsor. The 10 most frequent:
Air Force Military Medical University, China is the lead sponsor of 178 studies on the registry; 37 are open to participants now.
10 studies in Pancreatitis by Air Force Military Medical University, China: 3 open now, 3 under way, none of them phase 3. Of 4 finished, 1 (25%) have results posted.
Among the 10 studies in Pancreatitis by Air Force Military Medical University, China, this one has the largest planned enrollment, is one of 3 that started in 2025, is one of 10 with no phase, and was the 9th registered.
Air Force Military Medical University, China’s Pancreatitis studies by the year they started, since 2012.
1 of the studies testing indomethacin in Pancreatitis that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07071441Air Force Military Medical University, ChinaIndomethacin vs Diclofenac for Preventing PEP | 2026-12-31 |
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Among the 20 studies testing indomethacin in Pancreatitis, from their registry updates:
Among Air Force Military Medical University, China’s 10 in Pancreatitis:
Nothing recorded among them since 2026-09-25.
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Pancreatitis is the most common and serious complication following post-endoscopic retrograde cholangiopancreatography (ERCP) and is associated with occasional mortality, extended hospital stays, and increased healthcare expenses. Preprocedural administration of rectal non-steroidal anti-inflammatory drugs (NSAIDs) was demonstrated to be an effective and convenient strategy for post-ERCP pancreatitis (PEP). Furthermore, several meta-analyses found that only 100mg indomethacin and diclofenac could effectively reduce PEP. Therefore, updated international clinical practice guidelines uniformly recommended administration of 100mg indomethacin or diclofenac in patients without contradictions. However, it was unclear which one of the two drug is more superior.
A recent meta-analysis suggested 100mg rectal diclofenac was more efficacious than same-dose rectal indomethacin in PEP prevention (relative risk (RR) 0·59, 95% confidence intervals (CI) 0·40-0·89). Based on the results, we conducted a multicenter, double-blind, control trial to investigate whether 100mg diclofenac is superior than same-dose indomethacin. This trial planned to enroll 3612 patients in total. However, in the first interim analysis, PEP occurred in 53 patients (8.8%) of 600 patients allocated to diclofenac group and 37 patients (6.1%) of 604 patients allocated to indomethacin group (relative risk (RR) 1.44; 95% confidence interval (CI) 0.96-2.16, p=0.074). Thus, the trial was stopped according to the futility rule of conditional power. However, it was worth noticing that PEP tended to be higher in diclofenac group than that in indomethacin group. A sample size of 1204 was under power to draw the conclusion of significantly lower PEP rate in indomethacin group and thus a new trial with larger sample size of sufficient power is predicted to prove the superiority of indomethacin over diclofenac. Here we conducted a multicenter, randomized, double-blind trial to investigate whether 100mg indomethacin is superior to 100mg diclofenac in preventing PEP.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All patients without contraindications should receive 100mg rectal indomethacin within 30mins before ERCP procedure
Drug: Indomethacin 100 MG
All patients without contraindications should receive 100mg rectal diclofenac within 30mins before ERCP procedure
Drug: Diclofenac 100mg
All patients without contraindications should receive 100mg rectal indomethacin within 30mins before ERCP procedure
All patients without contraindications should receive 100mg rectal diclofenac within 30mins before ERCP procedure
Rate of post-ERCP Pancreatitis
a new or aggravated upper abdominal pain, with an elevated pancreatic enzyme of at least 3 times as the upper limit of normal value 24h after procedure and prolonged hospitalization days for at least 2 days. This definition was based on a widely recognized Cotton consensus
Time frame: 30 days
Rate of mild, moderate or severe PEP
The severity classification of post-ERCP pancreatitis was defined according to the Cotton Criteria. Mild PEP: with an extension of hospitalization period of 2-3 days; Moderate PEP: with an extension of hospitalization period of 4-10 days; Severe PEP: with an extension of more than 10 days, or hemorrhagic pancreatitis, phlegmon, or pseudocyst, intervention (percutaneous drainage or surgery), or death.
Time frame: 30 days
Rate of patients with different severity of pancreatitis evaluated by revised Atlanta criteria
Mild: The most common form of acute pancreatitis, without organ failure or local or systemic complications, generally resolving within 1 week of onset. Moderately Severe: the presence of transient organ failure, local complications or exacerbation of co-morbid disease. Severe: persistent organ failure, that is, organ failure \>48 h. Local complications are peripancreatic fluid collections, pancreatic and peripancreatic necrosis (sterile or infected), pseudocyst and walled-off necrosis (sterile or infected).
Time frame: 30 days
Rate of ERCP-related perforation
Perforation was established according to Cotton criteria, Mild: slight leakage of fluid or contrast dye, manageable through fluid administration and suction therapy ≤3 days Moderate: definite perforation required to be managed for 4-10 days Severe: management for more than 10 days or requiring for percutaneous or surgical intervention.
Time frame: 30 days
Rate of ERCP-related infection
Infection was established according to Cotton criteria. Mild: temperature \>38℃ for 24-48h Moderate: Febrile illness requiring \>3 days of hospital treatment; endoscopic or percutaneous interventions; Severe: septic shock or requiring surgery.
Time frame: 30 days
Rate of ERCP-related bleeding
Bleeding was established according to Cotton criteria. Mild: a documented decrease in hemoglobin concentration by \<3 g/L, without requiring the blood transfusion; Moderate: blood transfusion ≤4 units; without need for angiographic or surgery interventions Severe: Transfusion: ≥5 units or requiring for angiographic or surgery interventions.
Time frame: 30 days
Rate of NSAIDs-related complications
NSAIDs-related complications include: acute kidney injury, allergic reaction, gastrointestinal bleeding, myocardial infarction, cerebrovascular accident, and death
Time frame: 30 days
Rate of mortality
Time frame: 30 days
The rate of total adverse events
Adverse events include ERCP-related or non ERCP-related adverse events
Time frame: 30 days
Plan to share: Undecided
Started Jun 2025 (actual). Primary completion is estimated for Dec 2026, 18 months after the start.
Of 91 non-industry interventional studies with no phase under Pancreatitis, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 59. This study's planned 18 months is below that.
Counting every sponsor, half of 94 studies reached it within 32 months; a quarter within 23 and three quarters within 59.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Indomethacin
Air Force Military Medical University, China →