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NCT05069597 Clinical Trial

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

Cystic Fibrosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05069597
Other study ID # M21-432
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date October 14, 2021
Est. completion date August 28, 2023

Study information
Verified date September 2023
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date August 28, 2023
Est. primary completion date July 7, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• CREON
Capsule; Oral

Locations
Country Name City State
United States Albany Medical College-Pulmonary /ID# 250041 Albany New York
United States University of Cincinnati /ID# 229511 Cincinnati Ohio
United States Cleveland Clinic Main Campus /ID# 245864 Cleveland Ohio
United States UH Cleveland Medical Center /ID# 246065 Cleveland Ohio
United States The Curators of the University of Missouri /ID# 233331 Columbia Missouri
United States University of Florida - Archer /ID# 233411 Gainesville Florida
United States Baylor College of Medicine Medical Center /ID# 233441 Houston Texas
United States Dartmouth-Hitchcock Medical Center /ID# 231633 Lebanon New Hampshire
United States Atlantic Medical Research Group /ID# 239568 Margate Florida
United States University of Miami, Miller School of Medicine /ID# 239415 Miami Florida
United States Velocity Clinical Research /ID# 231076 Mobile Alabama
United States West Virginia University Hospitals /ID# 239593 Morgantown West Virginia
United States Asr, Llc /Id# 239566 Nampa Idaho
United States GI Pros /ID# 239486 Naples Florida
United States NYU Langone Health /ID# 233417 New York New York
United States Central FL Pulmonary Orlando /ID# 245863 Orlando Florida
United States Univ Texas HSC San Antonio /ID# 239060 San Antonio Texas
United States Options Health Research, LLC /ID# 239535 Tulsa Oklahoma
United States Wake Forest Baptist Health /ID# 229537 Winston-Salem North Carolina
United States UMass Chan Medical School /ID# 230476 Worcester Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Symptoms of Exocrine Pancreatic Insufficiency (EPI) Mean symptom scores will be summarized. Day 1 through Day 85
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