Study to Evaluate Symptoms of Exocrine Pancreatic Insufficiency in Adult Participants With Cystic Fibrosis or Chronic Pancreatitis Treated With Creon

Study Overview
=================
Brief Summary
-----------------
Exocrine pancreatic insufficiency (EPI) is a condition that is caused by the inadequate pancreatic enzymes needed for normal digestion and is commonly associated with a wide range of chronic diseases, including cystic fibrosis (CF), chronic pancreatitis (CP), and pancreatic cancer. This study will assess clinical symptoms when participants with CF or CP are treated with Creon with alternate source of active drug. Creon is an approved drug for the treatment of EPI due to CF or CP. This study is subject-blinded which means participants will not know the source of the study drug they are given. Approximately 30 adult participants with CF or CP will be enrolled at approximately 15 sites across the Unites States. Participants will receive oral capsules of CREON for 112 days and will be followed for 30 days. Participants will attend regular visits during the study at a hospital or clinic or via telemedicine. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.

Official Title
-----------------
A Phase 4 Study to Assess Symptoms of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis or Chronic Pancreatitis Treated With Creon® (Pancrelipase) With an Alternate Source of Active Pharmaceutical Ingredient

Conditions
-----------------
Cystic Fibrosis, Chronic Pancreatitis

Intervention / Treatment
-----------------
* Drug: CREON


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previous diagnosis of cystic fibrosis (CF) or chronic pancreatitis (CP). Previous diagnosis of exocrine pancreatic insufficiency (EPI) that is currently clinically controlled. Total Symptom Score (TSS) < 1.8 on Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q) at Screening. Exclusion Criteria: - Malignancy involving the digestive tract in the last 5 years, or other significant disease or medical condition that may interfere with EPI symptom assessment.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Run-in Period: Creon<br>Participants will receive Creon daily for 112 days. | Drug: CREON<br>* Capsule; Oral<br>* Other names: Pancrelipase;|
| Experimental: Treatment Period: Creon<br>Participants will receive Creon daily for 112 days. | Drug: CREON<br>* Capsule; Oral<br>* Other names: Pancrelipase;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms of Exocrine Pancreatic Insufficiency (EPI) | Mean symptom scores will be summarized. | Day 1 through Day 85 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cystic Fibrosis, Chronic Pancreatitis, Exocrine Pancreatic Insufficiency, Creon, Pancrelipase