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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


2020-05-06


2021-09-22


2021-09-22


0

Study Overview

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

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.

N/A

  • Exocrine Pancreatic Insufficiency (EPI)
  • DRUG: CREON
  • M16-112

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2020-03-18  

N/A  

2021-11-03  

2020-03-18  

N/A  

2021-11-08  

2020-03-19  

N/A  

2021-11  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment


Allocation:
Na


Interventional Model:
Single Group


Masking:
None


Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: CREON

Participants will receive daily dose of CREON.

DRUG: CREON

  • Capsule: Oral
Primary Outcome MeasuresMeasure DescriptionTime Frame
Change In Coefficient Of Fat Absorption (CFA) From BaselineCFA 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 MeasuresMeasure DescriptionTime Frame
Change In Gastrointestinal (GI) Symptoms From BaselineChange 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 BaselineStool 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 BaselineStool 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 BaselineChange from Baseline in vitamin D will be assessed through clinical laboratory testing.Up To Week 27
Change In Vitamin E From BaselineChange from Baseline in vitamin E will be assessed through clinical laboratory testing.Up To Week 27
Change In Vitamin K From BaselineChange from Baseline in vitamin K will be assessed through clinical laboratory testing.Up To Week 27
Change In Vitamin A From BaselineChange from Baseline in vitamin A will be assessed through clinical laboratory testing.Up To Week 27
Change In Retinol-Binding Protein From BaselineChange from Baseline in retinol-binding protein will be assessed through clinical laboratory testing.Up To Week 27
Change In Albumin From BaselineChange from Baseline in albumin will be assessed through clinical laboratory testing.Up To Week 27
Change In Prealbumin From BaselineChange from Baseline in prealbumin will be assessed through clinical laboratory testing.Up To Week 27
Change In Transferrin From BaselineChange from Baseline in transferrin will be assessed through clinical laboratory testing.Up To Week 27
Change In Weight From BaselineThe mean change of weight from Baseline will be calculated.Up To Week 27
Change In Body Mass Index (BMI) From BaselineBMI is a measure of body fat based on weight in relation to height.Up To Week 27
Change In Hip Circumference From BaselineHip circumference is measured by placing the measuring tape around the maximum circumference of the buttocks.Up To Week 27
Change In Waist Circumference From BaselineWaist 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 BaselineGIQLI 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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.


    • STUDY_DIRECTOR: ABBVIE INC., AbbVie

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available