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Anti-fibrotic agent
Pirfenidone for Recurrent Acute Pancreatitis (PirfenidoneRAP Trial)
Phase 2
Recruiting
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients 18 - 85 years of age
typical upper abdominal pain according to the revised Atlanta classification28
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Summary
This trial will test whether pirenidone is safe and well-tolerated in patients with recurrent acute pancreatitis, and will also look at its early effectiveness.
Who is the study for?
This trial is for adults aged 18-85 who have had recurrent acute pancreatitis, which means they've experienced multiple episodes of this condition. Participants must have been discharged from the hospital and show certain levels of digestive enzymes indicating pancreatitis. They should not be currently hospitalized.
What is being tested?
The study is testing Pirfenidone, a medication that could potentially treat recurrent acute pancreatitis, against a placebo (a substance with no therapeutic effect). The goal is to see if Pirfenidone can safely reduce symptoms and prevent future attacks.
What are the potential side effects?
While the specific side effects for this trial are not listed, common side effects of Pirfenidone may include stomach discomfort, nausea, fatigue, skin sensitivity to sunlight or rash. Placebo typically has no side effects but can cause reactions based on patient expectations.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 85 years old.
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I experience severe upper belly pain.
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My pancreatitis is moderate to severe.
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I have been discharged from the hospital.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adverse Event
Secondary study objectives
Development of CP
Development of Chronic Pancreatitis
Development of Diabetes
+6 moreSide effects data
From 2019 Phase 3 trial • 60 Patients • NCT0320893327%
Nausea
22%
Decreased appetite
13%
Dyspepsia
13%
Vomiting
12%
Diarrhoea
10%
Dyspnoea
7%
Cough
7%
Weight decreased
7%
Pruritus
3%
Idiopathic pulmonary fibrosis
3%
Death
2%
Bronchitis chronic
2%
Sudden cardiac death
2%
Atrial fibrillation
2%
Atrial flutter
2%
Bronchitis bacterial
2%
Cholecystitis infective
2%
Pneumonia
2%
Adenocarcinoma of colon
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pirfenidone
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: PirfenidoneExperimental Treatment1 Intervention
Pirfenidone Days 1-7: 267 mg PO TID (801 mg/day) Days 8-14: 534 mg PO TID (1602 mg/day) Day 15 and thereafter: 801 mg PO TID; not to exceed 2403 mg/day Total duration of experimental or placebo drug treatment 6 months
Group II: PlaceboPlacebo Group1 Intervention
Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pirfenidone
2006
Completed Phase 3
~2600
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,655 Previous Clinical Trials
2,444,098 Total Patients Enrolled
5 Trials studying Pancreatitis
336 Patients Enrolled for Pancreatitis
Congressionally Directed Medical Research ProgramsFED
57 Previous Clinical Trials
10,413 Total Patients Enrolled