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
Trial Snapshot
- Phase
- Phase 4
- Status
- Withdrawn
- Sponsor
- Primary Endpoint
- Change In Coefficient Of Fat Absorption (CFA) From Baseline
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
CREON
Participants will receive daily dose of CREON.
Intervention: CREON (Drug)
Outcomes
Primary Outcomes
Change In Coefficient Of Fat Absorption (CFA) From Baseline
Time Frame: Week 1
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.
Secondary Outcomes
- Change In Albumin From Baseline(Up To Week 27)
- Change In Gastrointestinal Quality Of Life Index (GIQLI) From Baseline(Up To Week 27)
- Change In Gastrointestinal (GI) Symptoms From Baseline(Week 1)
- Change In Stool Consistency From Baseline(Week 1)
- Change In Prealbumin From Baseline(Up To Week 27)
- Change In Weight From Baseline(Up To Week 27)
- Change In Waist Circumference From Baseline(Up To Week 27)
- Change In Stool Frequency From Baseline(Week 1)
- Change In Vitamin D From Baseline(Up To Week 27)
- Change In Body Mass Index (BMI) From Baseline(Up To Week 27)
- Change In Retinol-Binding Protein From Baseline(Up To Week 27)
- Change In Transferrin From Baseline(Up To Week 27)
- Change In Vitamin E From Baseline(Up To Week 27)
- Change In Vitamin K From Baseline(Up To Week 27)
- Change In Vitamin A From Baseline(Up To Week 27)
- Change In Hip Circumference From Baseline(Up To Week 27)