Effect of CREON on Exocrine Pancreatic Insufficiency (EPI) Symptoms

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

63 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-16

Study Completion Date

2024-02-29

Brief Summary

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Exocrine Pancreatic Insufficiency (EPI) is a condition where pancreatic enzyme quantity or activity is reduced below threshold needed for normal digestion. Symptoms include bloating, flatulence, diarrhea and steatorrhea. This is an observational study assessing for effect of CREON on symptoms of EPI in participants with EPI due to chronic pancreatitis.

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Detailed Description

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Conditions

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Chronic Pancreatitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants on CREON

CREON

Intervention Type DRUG

Oral Capsules

Interventions

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CREON

Oral Capsules

Intervention Type DRUG

Other Intervention Names

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pancrelipase ABT-SLV245

Eligibility Criteria

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Inclusion Criteria

* Medical history of chronic pancreatitis (CP).
* Diagnosis of Exocrine Pancreatic Insufficiency (EPI).

Exclusion Criteria

--History of cystic fibrosis, pancreatic cancer, pancreatic surgery, gastric bypass surgery, extensive bowel surgery, inflammatory bowel disease, celiac disease, irritable bowel syndrome

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No