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

AbbVie30 enrolled

Overview

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. 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 113 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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Cystic Fibrosis Chronic Pancreatitis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (21)

Velocity Clinical Research /ID# 231076

Mobile, Alabama, United States

Valley Children's Hospital /ID# 231452

Madera, California, United States

University of Florida - Archer /ID# 233411

Gainesville, Florida, United States

Atlantic Medical Research /ID# 239568

Margate, Florida, United States

University of Miami, Miller School of Medicine /ID# 239415

Miami, Florida, United States

GI Pros /ID# 239486

Naples, Florida, United States

Central FL Pulmonary Orlando /ID# 245863

Orlando, Florida, United States

Asr, Llc /Id# 239566

Nampa, Idaho, United States

UMass Chan Medical School /ID# 230476

Worcester, Massachusetts, United States

The Curators of the University of Missouri /ID# 233331

Columbia, Missouri, United States

...and 11 more locations

Outcomes

Primary Outcomes

Mean Change in Total Symptom Score (TSS) From Day 1 (Baseline) to Days 8, 15, 29, and 85

The Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q) is an 18-item Patient-Reported Outcome (PRO) instrument that assesses EPI symptoms and associated impact over the previous 7 days. All items are scored using a 5-point Likert scale (Not at all to Yes, a lot). The average score for each symptom domain is calculated, ranging from 0 to 4. TSS is calculated from the average of the mean abdominal domain score and the mean bowel movement symptom score. A numerically higher response indicates more severe EPI symptoms. Positive changes from baseline indicate a worsening of symptoms.

Time frame: Day 1 (baseline), 8, 15, 29, and 85

Mean Change in Abdominal Symptom Domain Score (ASDS) From Day 1 (Baseline) to Days 8, 15, 29, and 85

The PEI-Q is an 18-item PRO instrument that assesses EPI symptoms and associated impact over the previous 7 days. All items are scored using a 5-point Likert scale (Not at all to Yes, a lot). The average score for each symptom domain is calculated, ranging from 0 to 4. ASDS is the mean abdominal symptom domain score measured by the PEI-Q. A numerically higher response indicates more severe EPI symptoms. Positive changes from baseline indicate a worsening of symptoms.

Time frame: Day 1 (Baseline), 8, 15, 29, and 85

Mean Change in Bowel Movement Symptom Score (BMSS) From Day 1 (Baseline) to Days 8, 15, 29, and 85

The PEI-Q is an 18-item PRO instrument that assesses EPI symptoms and associated impact over the previous 7 days. All items are scored using a 5-point Likert scale (Not at all to Yes, a lot). The average score for each symptom domain is calculated, ranging from 0 to 4. BMSS is the mean bowel movement symptom domain score measured by the PEI-Q. A numerically higher response indicates more severe EPI symptoms. Positive changes from baseline indicate a worsening of symptoms.