Long-term Study in US Cystic Fibrosis Patients Receiving Digestive Enzyme Supplements to Assess Narrowing of the Large Intestine Causing Adverse Intestinal Symptoms (Fibrosing Colonopathy)

Study Identifier
CFFC-OB-11
CT.gov Identifier
NCT01652157
EudraCT Identifier
Not available
EUCTIS ID
Not available
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844-663-3742 or [email protected]

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Results Available

Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Digestive & Intestinal - Other
    • Study Drug
  • ULTRESA
  • PANCREAZE
  • CREON
  • ZENPEP
  • other non-sponsor pancreatic enzyme replacement therapy
  • PERTZYE
    • Phase
    N/A
    Sex
    Female & Male
    Age
    0 Months - 99 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    The inclusion criteria for enrollment in the Base Study Population * Diagnosed with cystic fibrosis, * Enrolled in the Cystic Fibrosis Patient Registry * Receiving medical care at a Cystic Fibrosis Foundation-accredited care center providing data to the Cystic Fibrosis Patient Registry
    Exclusion Criteria:
    * None

    Protocol Summary

    This is a long-term study in cystic fibrosis patients who are participating in the Cystic Fibrosis Patient Registry to assess the occurrence and risk factors for a rare bowel disorder called fibrosing colonopathy (narrowing of the large intestine). Patients will be followed at their regular clinical care visits over a 10-year period and approached if they develop symptoms of fibrosing colonopathy for collection and use of further detailed information.

    Study Locations

    Location
    Status
    Location
    Children's Hospital of Alabama /ID# 78920
    Birmingham, Alabama, United States, 35233
    Status
    Not applicable
    Location
    Alaska Medical Center /ID# 79256
    Anchorage, Alaska, United States, 99508
    Status
    Not applicable
    Location
    Phoenix Children's Hospital /ID# 78906
    Phoenix, Arizona, United States, 85016-7710
    Status
    Not applicable
    Location
    University of Arizona Cancer Center - North Campus /ID# 78939
    Tucson, Arizona, United States, 85719-1478
    Status
    Not applicable
    Location
    Arkansas Children's Hospital /ID# 79265
    Little Rock, Arkansas, United States, 72202
    Status
    Not applicable
    Location
    University of Arkansas for Medical Sciences /ID# 76785
    Little Rock, Arkansas, United States, 72205
    Status
    Not applicable
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