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

NCT04315311 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: M16-112
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Exocrine Pancreatic Insufficiency (EPI)

Keywords

EPI; Exocrine pancreatic insufficiency; ABT-SLV245; Creon; Pancrelipase

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Change In Gastrointestinal (GI) Symptoms From Baseline

  Week 1

• Change In Stool Frequency From Baseline

  Week 1

• Change In Stool Consistency From Baseline

  Week 1

• Change In Vitamin D From Baseline

  Up To Week 27

• Change In Vitamin E From Baseline

  Up To Week 27

Study Arms (1)

CREON

EXPERIMENTAL

Participants will receive daily dose of CREON.

Drug: CREON

Interventions

CREON DRUG

Capsule: Oral

Also known as: Pancrelipase, ABT-SLV245

CREON

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• History of cystic fibrosis, chronic pancreatitis, pancreatectomy, pancreatic cancer, or fibrosing colonopathy.

Sponsors & Collaborators

• AbbVie: lead

Related Links

• Related info

MeSH Terms

Conditions

Exocrine Pancreatic Insufficiency

Interventions

Pancrelipase

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Lipase; Carboxylic Ester Hydrolases; Esterases; Hydrolases; Enzymes; Enzymes and Coenzymes; Pancreatic Extracts; Tissue Extracts; Complex Mixtures

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2020
• First Posted: March 19, 2020
• Study Start: May 6, 2020
• Primary Completion: September 22, 2021
• Study Completion: September 22, 2021
• Last Updated: November 8, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
• 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.