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Enzyme Replacement Therapy

Pancreatic Enzyme Replacement Therapy for Pancreatic Insufficiency (PERT-AP Trial)

Phase 4

Recruiting

Research Sponsored by Ohio State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have a Body Weight between 40 and 120 kg (amounts to 600-1800 LU/meal pancrelipase starting dose of pancrelipase)

Must have fully completed the terminal intervention for necrotizing pancreatitis (surgical or endoscopic necrosectomy or percutaneous drainage)

Must not have

History of definite chronic pancreatitis defined by APA Chronic Pancreatitis Guideline

Gastroparesis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 210 days

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Drug Has Already Been Approved

Summary

This trial aims to see if taking pancrelipase (CREON) for 6 months can help improve symptoms of exocrine pancreatic insufficiency after an acute pancreatitis attack. Patients with low fec

Who is the study for?

This trial is for individuals who have had an acute pancreatitis attack and are now experiencing symptoms of exocrine pancreatic insufficiency (EPI), confirmed by a fecal elastase test showing less than 200. Participants should be willing to take pancrelipase capsules for six months and complete health surveys.

What is being tested?

The study tests whether taking pancrelipase (CREON) for six months can improve EPI symptoms following acute pancreatitis. It involves regular blood and stool tests, as well as completing surveys to monitor symptom changes over the treatment period.

What are the potential side effects?

Possible side effects of taking pancrelipase may include gastrointestinal discomfort such as gas, bloating, constipation or diarrhea, nausea, abdominal cramps, and hypersensitivity reactions if allergic.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My weight is between 40 and 120 kg.

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I have completed treatment for severe pancreatitis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a confirmed history of chronic pancreatitis.

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I have been diagnosed with gastroparesis.

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I have had surgery on my pancreas or upper GI tract.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 210 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~210 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 210 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Patient-Reported EPI Symptoms - Short Term

Secondary study objectives

Change in Depression Score

Change in Global Health Score

Change in Nutrition Biomarkers - Albumin

+6 more

Other study objectives

Change in Stool Consistency

Change in Stool Frequency

Frequency, Type, and Severity of Adverse Events

+1 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

1Treatment groups

Experimental Treatment

Group I: PancrelipaseExperimental Treatment1 Intervention

Pancrelipase (CREON) capsules taken orally with food, at a dose 36,000 units with snacks and 72,000 units with meals, for a total of 6 months (180 days)

0 / 5Eligibility criteria met