Clinical trial NCT04315311: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Exocrine Pancreatic Insufficiency (EPI)
Keywords: EPI
Exocrine pancreatic insufficiency
ABT-SLV245
Creon
Pancrelipase
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2020-03-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change In Coefficient Of Fat Absorption (CFA) From Baseline
timeFrame: Week 1
Secondary outcomes:
measure: Change In Gastrointestinal (GI) Symptoms From Baseline
timeFrame: Week 1
measure: Change In Stool Frequency From Baseline
timeFrame: Week 1
measure: Change In Stool Consistency From Baseline
timeFrame: Week 1
measure: Change In Vitamin D From Baseline
timeFrame: Up To Week 27
measure: Change In Vitamin E From Baseline
timeFrame: Up To Week 27
measure: Change In Vitamin K From Baseline
timeFrame: Up To Week 27
measure: Change In Vitamin A From Baseline
timeFrame: Up To Week 27
measure: Change In Retinol-Binding Protein From Baseline
timeFrame: Up To Week 27
measure: Change In Albumin From Baseline
timeFrame: Up To Week 27
measure: Change In Prealbumin From Baseline
timeFrame: Up To Week 27
measure: Change In Transferrin From Baseline
timeFrame: Up To Week 27
measure: Change In Weight From Baseline
timeFrame: Up To Week 27
measure: Change In Body Mass Index (BMI) From Baseline
timeFrame: Up To Week 27
measure: Change In Hip Circumference From Baseline
timeFrame: Up To Week 27
measure: Change In Waist Circumference From Baseline
timeFrame: Up To Week 27
measure: Change In Gastrointestinal Quality Of Life Index (GIQLI) From Baseline
timeFrame: Up To Week 27
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: