Pancreatic Enzyme Replacement Therapy for Acute Pancreatitis-Associated Exocrine Pancreatic Insufficiency

Part of paid clinical trials in Los Angeles, California.

Sponsor
Ohio State University
Study ID
NCT06477159
Phase
PHASE4
Status
Recruiting
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Conditions

  • Exocrine Pancreatic Insufficiency

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pancrelipase Capsules — DRUG
    Treatment with Pancreatic Enzyme Replacement Therapy

Study Details

This study aims to evaluate if a 6-month course of pancrelipase (CREON) treatment improves symptoms of exocrine pancreatic insufficiency (EPI) after an attack of acute pancreatitis. Diagnosis of EPI is measured by a fecal elastase value of \<200, and patients must have a qualifying symptom burden based on the EPI symptom tracker survey. Blood and stool will be analyzed as part of this study, and other surveys of health status will be used to track improvement of symptoms.

Key Dates

Start date
Feb 1, 2024
Status verified
Jun 2026
Primary completion
Sep 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pancrelipase
    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)

Primary Outcome Measure

Patient-Reported EPI Symptoms - Short Term [ Time Frame: 30 days ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
University of Southern CaliforniaLos AngelesCalifornia90033
Jorge Zuniga Gomez
[email protected]
James Buxbaum, MD (PRINCIPAL_INVESTIGATOR)
University of Illinois ChicagoChicagoIllinois60612
Haya Alrashdan, MSN
[email protected]
312-413-0306
Cemal Yazici, MD (PRINCIPAL_INVESTIGATOR)
University of MinnesotaMinneapolisMinnesota55455
Cathy Kneeland, RN
[email protected]
Guru Trikudanathan, MD (PRINCIPAL_INVESTIGATOR)
New York University Langone Medical CenterNew YorkNew York10016-
The Ohio State UniversityColumbusOhio43210
Zoe Krebs, BA
[email protected]
614-685-3619
Samantha Terhorst, MS
[email protected]
Georgios Papachristou, MD, PhD (PRINCIPAL_INVESTIGATOR)
Peter Lee, MbCHb (SUB_INVESTIGATOR)
University of PittsburghPittsburghPennsylvania15213
Apsara Mishra
[email protected]
412-624-9310
Anna Phillips, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By research site
University of Southern California· Los Angeles, CAUniversity of Illinois Chicago· Chicago, ILUniversity of Minnesota· Minneapolis, MNNew York University Langone Medical Center· New York, NYThe Ohio State University· Columbus, OHUniversity of Pittsburgh· Pittsburgh, PA

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