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NCT05252754 · ClinicalTrials.gov registry record · Phase 3
Rectal Indomethacin and Oral Tacrolimus Versus Combination to Prevent Post-ERCP Pancreatitis
A Phase 3 study of Post-ERCP Acute Pancreatitis, sponsored by Johns Hopkins University.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 4,874
- Enrollment target
- 5
- Study locations
NCT05252754: Recruiting Phase 3 study of Post-ERCP Acute Pancreatitis, sponsored by Johns Hopkins University.
NCT05252754 is a Phase 3 study of Post-ERCP Acute Pancreatitis that is actively recruiting participants, run by Johns Hopkins University. The registered enrollment target is 4,874 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (531% higher). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05252754, a Phase 3 study of Post-ERCP Acute Pancreatitis, is actively recruiting participants, sponsored by Johns Hopkins University.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 4,874 participants
- Enrollment target
- 5
- Study locations
Study Summary
This research is being done to see if using oral tacrolimus before endoscopy, can prevent pancreatitis that may occur after ERCP (a type of gastrointestinal endoscopy).
Primary Outcome
Incidence of PEP as defined by the consensus guidelines as 1. New or increased abdominal pain that is clinically consistent with a syndrome of acute pancreatitis 2. Amylase or lipase ≥ 3x the upper limit of normal 24 hours after the procedure 3. Hospitalization or prolongation of existing hospitalization for at least 2 days
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Tacrolimus capsule
- DRUG Rectal Indomethacin
Study Locations (5)
Other
- Post Graduate Institute of Medical Education and Research - Chandigarh
- Singapore General Hospital - Singapore
Maryland
- Johns Hopkins Hospital - Baltimore
Andhra Pradesh
- Asian Institute of Gastroenterology - Hyderabad
West Bengal
- Apollo Multispecialty Hospitals, - Kolkata
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,874 participants |
| Start Date | 2023-01-18 |
| Est. Completion | 2026-12 |
| Phase | Phase 3 |
What NCT05252754 shows while recruiting
NCT05252754 is an interventional study that assigns participants to a tested intervention. Its 4,874 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (531% higher).
The record links to 1 condition, with Post-ERCP Acute Pancreatitis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT05252754 lists 5 locations in 4 states (Other, Maryland, Andhra Pradesh).
Frequently Asked Questions
What is clinical trial NCT05252754 about?
NCT05252754 is a clinical study titled "Rectal Indomethacin and Oral Tacrolimus Versus Combination to Prevent Post-ERCP Pancreatitis". This research is being done to see if using oral tacrolimus before endoscopy, can prevent pancreatitis that may occur after ERCP (a type of gastrointestinal endoscopy).
What is the current status of trial NCT05252754?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 4,874 participants. The study started on 2023-01-18. Estimated completion is 2026-12.
What conditions does trial NCT05252754 study?
This clinical trial studies the following conditions: Post-ERCP Acute Pancreatitis.
What interventions are being tested in trial NCT05252754?
The interventions under investigation include: Placebo (DRUG), Tacrolimus capsule (DRUG), Rectal Indomethacin (DRUG).
Who is sponsoring clinical trial NCT05252754?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05252754 being conducted?
This trial has 5 study locations across Maryland, Andhra Pradesh, West Bengal. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Post-ERCP Acute Pancreatitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05252754's enrollment target sits among peer trials
4,874 52nd of 2000 higher than 1,949 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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