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

NCT05252754 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4874

Last updated 2025-12-09

No results posted yet for this 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).

Conditions

  • Post-ERCP Acute Pancreatitis

Interventions

DRUG

Tacrolimus capsule

Tacrolimus 5 mg PO, 1-2 hours prior to endoscopy

DRUG

Placebo

Placebo PO, 1-2 hours prior to endoscopy.

DRUG

Rectal Indomethacin

100 mg Rectal Indomethacin immediately after ERCP, in high-risk patients.

Sponsors & Collaborators

Principal Investigators

  • Venkata S. Akshintala, M.D. · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-18
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States
  • India
  • Singapore

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05252754 on ClinicalTrials.gov