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

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

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 Overview

• Status: Withdrawn
• Conditions: Exocrine Pancreatic Insufficiency (EPI)
• Intervention / Treatment: Drug: CREON

• Study Type: Interventional
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CREON; Participants will receive daily dose of CREON.	Drug: CREON; Capsule: Oral; Other Names: Pancrelipase; ABT-SLV245

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: AbbVie

Publications and helpful links

Helpful Links

• Related info

Study record dates

Study Major Dates

• Study Start (Anticipated): May 6, 2020
• Primary Completion (Actual): September 22, 2021
• Study Completion (Actual): September 22, 2021

Study Registration Dates

• First Submitted: March 18, 2020
• First Submitted That Met QC Criteria: March 18, 2020
• First Posted (Actual): March 19, 2020

Study Record Updates

• Last Update Posted (Actual): November 8, 2021
• Last Update Submitted That Met QC Criteria: November 3, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Pancrelipase; Creon; ABT-SLV245; EPI; Exocrine pancreatic insufficiency
• Additional Relevant MeSH Terms: Digestive System Diseases; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Cystic Fibrosis; Pancreatitis; Pancreatitis, Chronic; Exocrine Pancreatic Insufficiency; Gastrointestinal Agents; Pancrelipase
• Other Study ID Numbers: M16-112

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
• IPD Sharing Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No