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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 below

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

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 more

Side effects data

From 2019 Phase 3 trial • 60 Patients • NCT03208933

27%

Nausea

22%

Decreased appetite

13%

Dyspepsia

13%

Vomiting

12%

Diarrhoea

10%

Dyspnoea

Cough

Weight decreased

Pruritus

Idiopathic pulmonary fibrosis

Death

Bronchitis chronic

Sudden cardiac death

Atrial fibrillation

Atrial flutter

Bronchitis bacterial

Cholecystitis infective

Pneumonia

Adenocarcinoma of colon

100%

80%

60%

40%

20%

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

0 / 4Eligibility criteria met