Study Of Effects Of Oral CREON Capsules In Adult Participants With Exocrine Pancreatic Insufficiency Not Due To Cystic Fibrosis, Chronic Pancreatitis, Pancreatectomy, Or Pancreatic Cancer

Study Overview
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Brief Summary
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Exocrine pancreatic insufficiency (EPI) is a condition where the pancreas does not have enough pancreatic enzymes to break down food. Some symptoms of EPI are frequent gas/bloating, unexplained stomach pains, frequent diarrhea, and foul-smelling, greasy stools. The purpose of this study is to see how effective CREON is for treating symptoms of EPI due to causes other than cystic fibrosis (CF), chronic pancreatitis (CP), pancreatectomy (PY), or pancreatic cancer (PC). CREON (Pancrelipase) is an approved drug used to treat people who cannot digest food normally due to their pancreas not making enough enzymes. Adult participants with a diagnosis of EPI due to causes other than CF, CP, PY, or PC will be enrolled. Around 50 participants will be enrolled in approximately 20 sites in the United States. Participants will receive oral CREON capsules with each meal and snack beginning at Day 1 for 27 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or a clinic. Participants will need to be confined for 2 separate periods of 6 to 8 days each to measure Co-efficient of Fat Absorption (during screening and after enrollment). The effect of the treatment will be checked by medical assessments, blood and stool tests, checking for side effects and completing questionnaires.

Official Title
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A Phase 4 Open-Label Single-Arm Study To Evaluate The Use Of CREON In Subjects With EPI Due To Etiologies Other Than Cystic Fibrosis, Chronic Pancreatitis, Pancreatectomy, Or Pancreatic Cancer

Conditions
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Exocrine Pancreatic Insufficiency (EPI)

Intervention / Treatment
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* Drug: CREON


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of exocrine pancreatic insufficiency (EPI). Participants who are on pancreatic enzyme replacement therapy (PERT) at the time of consent must have a clinical diagnosis of EPI by their physician. Exclusion Criteria: History of cystic fibrosis, chronic pancreatitis, pancreatectomy, pancreatic cancer, or fibrosing colonopathy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CREON<br>Participants will receive daily dose of CREON. | Drug: CREON<br>* Capsule: Oral<br>* Other names: ABT-SLV245;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change In Coefficient Of Fat Absorption (CFA) From Baseline | CFA is calculated as 100*[fat intake - stool fat]/fat intake. Fat intake will be determined from fat content of food consumed on Days 3 to 5 in the confinement period. Stool fat will be determined from the fat content in the stool(s) collected between the two dye markers in the confinement period. | Week 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change In Gastrointestinal (GI) Symptoms From Baseline | Change in GI symptoms is measured by AbbVie exocrine pancreatic insufficiency (EPI) symptom questionnaire. EPI symptom questionnaire is a 12-item patient-reported outcome (PRO) instrument that assesses EPI symptoms over the past 7 days. | Week 1 | 
| Change In Stool Frequency From Baseline | Stool frequency per 24 hours will be recorded daily during the 2 confinement periods. The average stool frequency per 24 hours during confinement period 1 will be considered as baseline. | Week 1 | 
| Change In Stool Consistency From Baseline | Stool consistency will be evaluated using the Bristol Stool Scale. The Bristol Stool chart is a medical aid designed to classify feces. | Week 1 | 
| Change In Vitamin D From Baseline | Change from Baseline in vitamin D will be assessed through clinical laboratory testing. | Up To Week 27 | 
| Change In Vitamin E From Baseline | Change from Baseline in vitamin E will be assessed through clinical laboratory testing. | Up To Week 27 | 
| Change In Vitamin K From Baseline | Change from Baseline in vitamin K will be assessed through clinical laboratory testing. | Up To Week 27 | 
| Change In Vitamin A From Baseline | Change from Baseline in vitamin A will be assessed through clinical laboratory testing. | Up To Week 27 | 
| Change In Retinol-Binding Protein From Baseline | Change from Baseline in retinol-binding protein will be assessed through clinical laboratory testing. | Up To Week 27 | 
| Change In Albumin From Baseline | Change from Baseline in albumin will be assessed through clinical laboratory testing. | Up To Week 27 | 
| Change In Prealbumin From Baseline | Change from Baseline in prealbumin will be assessed through clinical laboratory testing. | Up To Week 27 | 
| Change In Transferrin From Baseline | Change from Baseline in transferrin will be assessed through clinical laboratory testing. | Up To Week 27 | 
| Change In Weight From Baseline | The mean change of weight from Baseline will be calculated. | Up To Week 27 | 
| Change In Body Mass Index (BMI) From Baseline | BMI is a measure of body fat based on weight in relation to height. | Up To Week 27 | 
| Change In Hip Circumference From Baseline | Hip circumference is measured by placing the measuring tape around the maximum circumference of the buttocks. | Up To Week 27 | 
| Change In Waist Circumference From Baseline | Waist circumference is measured by placing a measuring tape on top of the hip bone and wrapping the tape around the waist. | Up To Week 27 | 
| Change In Gastrointestinal Quality Of Life Index (GIQLI) From Baseline | GIQLI is a 36-item patient reported outcome (PRO) instrument used to assess GI-specific quality of life in participants with GI disorders, with response score ranging from 0 to 4 (0 being all the time and 4 being never). | Up To Week 27 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EPI, Exocrine pancreatic insufficiency, ABT-SLV245, Creon, Pancrelipase