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NCT07247682
Dose-escalation of Rectal Indomethacin for Preventing PEP
Phase 4 trial testing standard-dose group VS high-dose group in Post-ERCP Pancreatitis in 1,036 participants. Not yet recruiting.
1 December 2028
Quick facts
| Lead sponsor | The First Affiliated Hospital of Anhui Medical University |
|---|---|
| Phase | Phase 4 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | prevention |
| Enrollment | 1,036 |
| Start date | 1 December 2025 |
| Primary completion | 1 December 2028 |
| Estimated completion | 30 December 2028 |
| Sites | 1 location across China |
Drugs / interventions tested
- standard-dose group VS high-dose group — full drug profile →
Conditions studied
- Post-ERCP Pancreatitis — all drugs for Post-ERCP Pancreatitis →
Sponsor
The First Affiliated Hospital of Anhui Medical University
Who can join
18 and older, any sex, with Post-ERCP Pancreatitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Our aim is to compare the efficacy of 100 mg versus 200 mg rectal indometacin in preventing post-ERCP pancreatitis (PEP) among high-risk patients without no pancreatic stenting. The 100 mg versus 200 mg indometacin trial is a multicentre, single-blind, randomized controlled study. High-risk patients for PEP without pancreatic stent insertion will be informed about the opportunity to participate. A total of 1,036 eligible patients will be randomly assigned in a 1:1 ratio to one of two groups: (1) administration of 100 mg rectal indometacin immediately after ERCP (standard-dose group), or (2) administration of 200 mg rectal indometacin immediately after ERCP (high-dose group). The primary outcome is the incidence and severity of PEP. Secondary outcomes include hyperamylasemia and other ERCP-related adverse events (AEs).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07247682
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Related trials
Other recruiting trials for Post-ERCP Pancreatitis
Currently open trials in the same condition.
- NCT07088757 — Low-Dose vs Standard-Dose Indomethacin for Preventing Post-ERCP Pancreatitis · Phase 4 · recruiting
- NCT06250803 — Early Pancreatic Stent Placement for Preventing PEP · NA · recruiting
Other The First Affiliated Hospital of Anhui Medical University trials
Trials by the same sponsor.
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- NCT07086287 — Evaluation of the Efficacy of rhBNP in Patients With Diuretic Resistance After Cardiac Surgery · NA · not yet recruiting
- NCT06565702 — Clinical Trial on the Accuracy of Blood Pressure Measurement by YE990 Medical Automatic Electronic Sphygmomanometer · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07247682 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The First Affiliated Hospital of Anhui Medical University
- Last refreshed: 25 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07247682.
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