A Phase 4 interventional study of CREON in Exocrine Pancreatic Insufficiency (EPI), sponsored by AbbVie. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-08.
Sponsored by AbbVie · Phase 4, Interventional, and Treatment
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.
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Exclusion Criteria:
Participants will receive daily dose of CREON.
Drug: CREON
Capsule: Oral
Also known as: Pancrelipase, ABT-SLV245
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.
Time frame: Week 1
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.
Time frame: 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.
Time frame: 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.
Time frame: Week 1
Change In Vitamin D From Baseline
Change from Baseline in vitamin D will be assessed through clinical laboratory testing.
Time frame: Up To Week 27
Change In Vitamin E From Baseline
Change from Baseline in vitamin E will be assessed through clinical laboratory testing.
Time frame: Up To Week 27
Change In Vitamin K From Baseline
Change from Baseline in vitamin K will be assessed through clinical laboratory testing.
Time frame: Up To Week 27
Change In Vitamin A From Baseline
Change from Baseline in vitamin A will be assessed through clinical laboratory testing.
Time frame: 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.
Time frame: Up To Week 27
Change In Albumin From Baseline
Change from Baseline in albumin will be assessed through clinical laboratory testing.
Time frame: Up To Week 27
Change In Prealbumin From Baseline
Change from Baseline in prealbumin will be assessed through clinical laboratory testing.
Time frame: Up To Week 27
Change In Transferrin From Baseline
Change from Baseline in transferrin will be assessed through clinical laboratory testing.
Time frame: Up To Week 27
Change In Weight From Baseline
The mean change of weight from Baseline will be calculated.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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").
Time frame: Up To Week 27
No study locations are listed for this record.
Plan to share: Yes — AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting information: Study protocol, Sap, Csr
This study is withdrawn, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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