Study to Evaluate Symptoms of Exocrine Pancreatic Insufficiency in Adult Participants With Cystic Fibrosis or Chronic Pancreatitis Treated With Creon
- Registration Number
- NCT05069597
- Lead Sponsor
- AbbVie
- 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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.
- Malignancy involving the digestive tract in the last 5 years, or other significant disease or medical condition that may interfere with EPI symptom assessment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Treatment Period: Creon-AAPIS CREON Participants will receive Creon-AAPIS daily for 85 days. Run-in Period: Creon-ABT CREON Participants will receive Creon-ABT daily for 28 days.
- Primary Outcome Measures
Name Time Method Mean Change in Bowel Movement Symptom Score (BMSS) From Day 1 (Baseline) to Days 8, 15, 29, and 85 Day 1 (Baseline), 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.
Mean Change in Total Symptom Score (TSS) From Day 1 (Baseline) to Days 8, 15, 29, and 85 Day 1 (baseline), 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.
Mean Change in Abdominal Symptom Domain Score (ASDS) From Day 1 (Baseline) to Days 8, 15, 29, and 85 Day 1 (Baseline), 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (21)
Valley Children's Hospital /ID# 231452
🇺🇸Madera, California, United States
Cleveland Clinic Main Campus /ID# 245864
🇺🇸Cleveland, Ohio, United States
Asr, Llc /Id# 239566
🇺🇸Nampa, Idaho, United States
Dartmouth-Hitchcock Medical Center /ID# 231633
🇺🇸Lebanon, New Hampshire, United States
Baylor College of Medicine Medical Center /ID# 233441
🇺🇸Houston, Texas, United States
University of Miami, Miller School of Medicine /ID# 239415
🇺🇸Miami, Florida, United States
Atlantic Medical Research /ID# 239568
🇺🇸Margate, Florida, United States
GI Pros /ID# 239486
🇺🇸Naples, Florida, United States
The Curators of the University of Missouri /ID# 233331
🇺🇸Columbia, Missouri, United States
UH Cleveland Medical Center /ID# 246065
🇺🇸Cleveland, Ohio, United States
Options Health Research, LLC /ID# 239535
🇺🇸Tulsa, Oklahoma, United States
Albany Medical College-Pulmonary /ID# 250041
🇺🇸Albany, New York, United States
NYU Langone Health /ID# 233417
🇺🇸New York, New York, United States
Velocity Clinical Research /ID# 231076
🇺🇸Mobile, Alabama, United States
University of Florida - Archer /ID# 233411
🇺🇸Gainesville, Florida, United States
UMass Chan Medical School /ID# 230476
🇺🇸Worcester, Massachusetts, United States
West Virginia University Hospitals /ID# 239593
🇺🇸Morgantown, West Virginia, United States
Central FL Pulmonary Orlando /ID# 245863
🇺🇸Orlando, Florida, United States
University of Cincinnati /ID# 229511
🇺🇸Cincinnati, Ohio, United States
Univ Texas HSC San Antonio /ID# 239060
🇺🇸San Antonio, Texas, United States
Wake Forest Baptist Health /ID# 229537
🇺🇸Winston-Salem, North Carolina, United States