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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04315311
Recruitment Status : Not yet recruiting
First Posted : March 19, 2020
Last Update Posted : August 11, 2020
Sponsor:
Information provided by (Responsible Party):
AbbVie

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 Asorption (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.


Condition or disease Intervention/treatment Phase
Exocrine Pancreatic Insufficiency (EPI) Drug: CREON Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : December 31, 2020
Estimated Primary Completion Date : March 7, 2022
Estimated Study Completion Date : July 5, 2023


Arm Intervention/treatment
Experimental: CREON
Participants will receive daily dose of CREON.
Drug: CREON
Capsule: Oral
Other Names:
  • Pancrelipase
  • ABT-SLV245




Primary Outcome Measures :
  1. Change In Coefficient Of Fat Absorption (CFA) From Baseline [ Time Frame: Week 1 ]
    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.


Secondary Outcome Measures :
  1. Change In Gastrointestinal (GI) Symptoms From Baseline [ Time Frame: Week 1 ]
    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.

  2. Change In Stool Frequency From Baseline [ Time Frame: Week 1 ]
    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.

  3. Change In Stool Consistency From Baseline [ Time Frame: Week 1 ]
    Stool consistency will be evaluated using the Bristol Stool Scale. The Bristol Stool chart is a medical aid designed to classify feces.

  4. Change In Vitamin D From Baseline [ Time Frame: Up To Week 27 ]
    Change from Baseline in vitamin D will be assessed through clinical laboratory testing.

  5. Change In Vitamin E From Baseline [ Time Frame: Up To Week 27 ]
    Change from Baseline in vitamin E will be assessed through clinical laboratory testing.

  6. Change In Vitamin K From Baseline [ Time Frame: Up To Week 27 ]
    Change from Baseline in vitamin K will be assessed through clinical laboratory testing.

  7. Change In Vitamin A From Baseline [ Time Frame: Up To Week 27 ]
    Change from Baseline in vitamin A will be assessed through clinical laboratory testing.

  8. Change In Retinol-Binding Protein From Baseline [ Time Frame: Up To Week 27 ]
    Change from Baseline in retinol-binding protein will be assessed through clinical laboratory testing.

  9. Change In Albumin From Baseline [ Time Frame: Up To Week 27 ]
    Change from Baseline in albumin will be assessed through clinical laboratory testing.

  10. Change In Prealbumin From Baseline [ Time Frame: Up To Week 27 ]
    Change from Baseline in prealbumin will be assessed through clinical laboratory testing.

  11. Change In Transferrin From Baseline [ Time Frame: Up To Week 27 ]
    Change from Baseline in transferrin will be assessed through clinical laboratory testing.

  12. Change In Weight From Baseline [ Time Frame: Up To Week 27 ]
    The mean change of weight from Baseline will be calculated.

  13. Change In Body Mass Index (BMI) From Baseline [ Time Frame: Up To Week 27 ]
    BMI is a measure of body fat based on weight in relation to height.

  14. Change In Hip Circumference From Baseline [ Time Frame: Up To Week 27 ]
    Hip circumference is measured by placing the measuring tape around the maximum circumference of the buttocks.

  15. Change In Waist Circumference From Baseline [ Time Frame: Up To Week 27 ]
    Waist circumference is measured by placing a measuring tape on top of the hip bone and wrapping the tape around the waist.

  16. Change In Gastrointestinal Quality Of Life Index (GIQLI) From Baseline [ Time Frame: Up To Week 27 ]
    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").



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04315311


Contacts
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Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

Locations
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United States, Florida
University of Florida - Archer /ID# 221433
Gainesville, Florida, United States, 32610
Jacksonville Center for Clinical Research /ID# 221724
Jacksonville, Florida, United States, 32216
University of Miami, Miller School of Medicine /ID# 221440
Miami, Florida, United States, 33136
United States, Kentucky
Scintipharma Inc. /ID# 223051
Lexington, Kentucky, United States, 40504-3152
United States, New York
Columbia University Medical Center /ID# 216890
New York, New York, United States, 10032-3729
United States, Texas
Baylor College of Medicine /ID# 217492
Houston, Texas, United States, 77030-3411
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie
Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT04315311    
Other Study ID Numbers: M16-112
First Posted: March 19, 2020    Key Record Dates
Last Update Posted: August 11, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (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.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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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
Keywords provided by AbbVie:
EPI
Exocrine pancreatic insufficiency
ABT-SLV245
Creon
Pancrelipase
Additional relevant MeSH terms:
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Cystic Fibrosis
Pancreatitis
Pancreatitis, Chronic
Exocrine Pancreatic Insufficiency
Digestive System Diseases
Pancreatic Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pancrelipase
Gastrointestinal Agents