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Rectal Indomethacin and Oral Tacrolimus Versus Combination to Prevent Post-ERCP Pancreatitis

Study acronym: INTRO
StatusRecruiting
PhasePhase 3
Started2023-01-18
View on ClinicalTrials.gov ↗

Amendment history

2025-12-05
Study Status v10
Re-verified, no change to tracked fields
2024-12-13
Study Status v9
Primary completion date2024-12→2026-12
Completion date2024-12→2026-12
2024-01-12
Study Status v8
Re-verified, no change to tracked fields
2023-01-30
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v7
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-01-01→confirmed 2023-01-18
Study sites5 entries, revised
Johns Hopkins Medicine - Sibley Memorial Hospital
2022-12-23
Study Status v6
Start date2022-12-01→2023-01-01
Show 5 earlier versions
2022-11-09
Study Status v5
Primary completion date2024-11→2024-12
Start date2022-11-01→2022-12-01
2022-10-14
Study Status v4
Start date2022-10-01→2022-11-01
2022-09-08
Study Status v3
Start date2022-09-01→2022-10-01
2022-08-31
Study Identification, Study Status v2
Re-verified, no change to tracked fields
2022-05-23
Study Status v1
Start date2022-05-01→2022-09-01
2022-02-14
Original filing
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).
Trial Details
NCT Number NCT05252754
Lead Sponsor Johns Hopkins University
Conditions Post-ERCP Acute Pancreatitis
Enrollment 4,874 participants
Start Date 2023-01-18
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2025-12-09