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Exocrine Pancreatic Insufficiency (EPI)Phase 4NCT04315311

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 study testing CREON in people with Exocrine Pancreatic Insufficiency (EPI), run by AbbVie.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Exocrine Pancreatic Insufficiency (EPI)
What is being tested?
CREON
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
6 May 2020to 22 Sep 2021
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

About this study

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

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.

Read more

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.

Being tested
CREON
Keywords
EPI, Exocrine pancreatic insufficiency, ABT-SLV245, Creon, Pancrelipase
Medical subject headings
Exocrine Pancreatic Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CREONDrug

    Also called Pancrelipase, ABT-SLV245

    Capsule: Oral

Study groups in NCT04315311
Study groupRoleWhat they receive
CREONExperimentalParticipants will receive daily dose of CREON.
Receives: Drug: CREON

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 1

Secondary outcomes (16)

  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.

    Measured: Week 1

  2. 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.

    Measured: Week 1

  3. 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.

    Measured: Week 1

  4. Change In Vitamin D From Baseline

    Change from Baseline in vitamin D will be assessed through clinical laboratory testing.

    Measured: Up To Week 27

  5. Change In Vitamin E From Baseline

    Change from Baseline in vitamin E will be assessed through clinical laboratory testing.

    Measured: Up To Week 27

  6. Change In Vitamin K From Baseline

    Change from Baseline in vitamin K will be assessed through clinical laboratory testing.

    Measured: Up To Week 27

  7. Change In Vitamin A From Baseline

    Change from Baseline in vitamin A will be assessed through clinical laboratory testing.

    Measured: Up To Week 27

  8. Change In Retinol-Binding Protein From Baseline

    Change from Baseline in retinol-binding protein will be assessed through clinical laboratory testing.

    Measured: Up To Week 27

  9. Change In Albumin From Baseline

    Change from Baseline in albumin will be assessed through clinical laboratory testing.

    Measured: Up To Week 27

  10. Change In Prealbumin From Baseline

    Change from Baseline in prealbumin will be assessed through clinical laboratory testing.

    Measured: Up To Week 27

  11. Change In Transferrin From Baseline

    Change from Baseline in transferrin will be assessed through clinical laboratory testing.

    Measured: Up To Week 27

  12. Change In Weight From Baseline

    The mean change of weight from Baseline will be calculated.

    Measured: Up To Week 27

  13. Change In Body Mass Index (BMI) From Baseline

    BMI is a measure of body fat based on weight in relation to height.

    Measured: Up To Week 27

  14. Change In Hip Circumference From Baseline

    Hip circumference is measured by placing the measuring tape around the maximum circumference of the buttocks.

    Measured: Up To Week 27

  15. 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.

    Measured: Up To Week 27

  16. 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").

    Measured: Up To Week 27

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2020
  2. Study start6 May 2020 (estimated)
  3. Primary completion22 Sep 2021
  4. Study completion22 Sep 2021

Why it stopped: Business Decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04315311
Sponsor's protocol ID
M16-112
Status last verified
Nov 2021
First submitted
18 Mar 2020
Last updated
8 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing CREON in people with Exocrine Pancreatic Insufficiency (EPI), run by AbbVie.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change In Coefficient Of Fat Absorption (CFA) From Baseline (time frame: Week 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04315311.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2021.

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