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Nonsteroidal Anti-inflammatory Drug (NSAID)
Indomethacin + Tacrolimus to Prevent Post-ERCP Pancreatitis (INTRO Trial)
Phase 3
Recruiting
Led By Venkata S. Akshintala, M.D.
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 30 days of ercp
Awards & highlights
INTRO Trial Summary
This trial is testing if tacrolimus, given before an ERCP, can prevent pancreatitis.
Who is the study for?
This trial is for adults undergoing ERCP at participating centers who can consent. It's not for those with certain pancreas or kidney conditions, pregnant or breastfeeding women, people allergic to tacrolimus/NSAIDs, or those currently on immune modulators.Check my eligibility
What is being tested?
The study tests if oral tacrolimus before an ERCP procedure can prevent post-ERCP pancreatitis compared to a placebo. Participants will receive either the drug or a placebo in a controlled environment.See study design
What are the potential side effects?
Tacrolimus may cause side effects like nausea, headaches, high blood pressure, and increased risk of infection. Indomethacin might lead to stomach pain, heartburn, dizziness and could potentially affect kidney function.
INTRO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 30 days of ercp
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 30 days of ercp
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The proportion of subjects in each study group with Post ERCP Acute Pancreatitis (PEP)
Secondary outcome measures
The proportion of subjects in each study group with moderate-severe Post-ERCP Pancreatitis
INTRO Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Oral Tacrolimus + IndomethacinExperimental Treatment2 Interventions
Tacrolimus Capsule 1-2 hours prior to the endoscopy
Rectal Indomethacin immediately after ERCP, in high-risk patients
Group II: Oral Placebo + IndomethacinPlacebo Group2 Interventions
Placebo Capsule 1-2 hours prior to the endoscopy
Rectal Indomethacin immediately after ERCP, in high-risk patients
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tacrolimus capsule
2011
Completed Phase 3
~90
Rectal Indomethacin
2014
N/A
~950
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Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,263 Previous Clinical Trials
14,818,291 Total Patients Enrolled
1 Trials studying Acute Pancreatitis
800 Patients Enrolled for Acute Pancreatitis
Venkata S. Akshintala, M.D.Principal InvestigatorJohns Hopkins University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am over 18 and agree to an ERCP procedure at a participating center.I have had acute pancreatitis within a month after an ERCP procedure.I have had a procedure to open my bile duct but don't expect a pancreas duct imaging.My cancer is located in the head of the pancreas.I am currently taking tacrolimus or an immune modulator.You are currently breastfeeding your baby.I do not have a rectum.I cannot take certain medications like tacrolimus or NSAIDs due to health reasons.I am scheduled for a procedure to change or remove a bile duct stent.I have been diagnosed with Type 3 Sphincter of Oddi dysfunction.I have chronic pancreatitis with calcium buildup.My kidney function is severely reduced or I have sudden kidney injury.You are pregnant.I have had a procedure on my bile ducts due to pancreas divisum.
Research Study Groups:
This trial has the following groups:- Group 1: Oral Tacrolimus + Indomethacin
- Group 2: Oral Placebo + Indomethacin
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA accepted Rectal Indomethacin for general use?
"There is some clinical data to support the efficacy of Rectal Indomethacin, and it has received multiple rounds of safety testing, so it has been given a score of 3."
Answered by AI
Are there any more places open for people who want to participate in this research?
"According to the information available on clinicaltrials.gov, this particular trial is not currently enrolling patients. The trial was originally posted on November 1st, 2020 and was last edited on October 14th, 2020. However, there are 92 other trials that are currently looking for patients."
Answered by AI
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