A Long-Term Prospective Observational Safety Study of the Incidence of and Risk Factors for Fibrosing Colonopathy in US Patients with Cystic Fibrosis Treated with Pancreatic Enzyme Replacement Therapy: A Harmonized Protocol Across Sponsors
Purpose: Subject will be enrolled when a physician suspects that you might have a condition called Fibrosing Colonopathy (FC). FC is a health problem that affects the colon and is seen almost only in patients with Cystic Fibrosis. FC is a painful swelling, shortening, and fibrosis (scarring) of the colon. Patients with FC may have abdominal pain, diarrhea, rectal bleeding, and in some cases, partial or complete blockage of their colon. It is not known exactly what causes FC. The purpose of this Study is to determine the number of patients affected by FC and to learn more about what might cause it, including use of pancreatic enzyme supplements. The U.S. Food and Drug Administration (FDA) has asked the manufacturers of pancreatic enzyme supplements to study the incidence of FC in Cystic Fibrosis patients to see if there may be a link between taking pancreatic enzyme medications and developing FC.
Eligibility: Subjects with cystic fibrosis, have pancreatic insufficiency, take pancreatic enzymes, and have suspected Fibrosis Colonopathy (FC).
Study status: Enrolling by physician discretion only
Sponsor: Abbott Laboratories (Abbott), Eurand Pharmaceuticals, Inc. (subsidiary of Aptalis Pharma), and Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Principal Investigator: Cori Daines, MD
Osmara Y. Molina de Rodriguez, MS
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