Study to Evaluate Symptoms of Exocrine Pancreatic Insufficiency in Adult Participants With Cystic Fibrosis or Chronic Pancreatitis Treated With Creon
NCT ID: NCT05069597
Last Updated: 2024-07-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
30 participants
INTERVENTIONAL
2021-10-14
2023-08-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
SINGLE
Study Groups
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Run-in Period: Creon-ABT
Participants will receive Creon-ABT daily for 28 days.
CREON
Capsule; Oral
Treatment Period: Creon-AAPIS
Participants will receive Creon-AAPIS daily for 85 days.
CREON
Capsule; Oral
Interventions
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CREON
Capsule; Oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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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
Dartmouth-Hitchcock Medical Center /ID# 231633
Lebanon, New Hampshire, United States
Albany Medical College-Pulmonary /ID# 250041
Albany, New York, United States
NYU Langone Health /ID# 233417
New York, New York, United States
Wake Forest Baptist Health /ID# 229537
Winston-Salem, North Carolina, United States
University of Cincinnati /ID# 229511
Cincinnati, Ohio, United States
UH Cleveland Medical Center /ID# 246065
Cleveland, Ohio, United States
Cleveland Clinic Main Campus /ID# 245864
Cleveland, Ohio, United States
Options Health Research, LLC /ID# 239535
Tulsa, Oklahoma, United States
Baylor College of Medicine Medical Center /ID# 233441
Houston, Texas, United States
Univ Texas HSC San Antonio /ID# 239060
San Antonio, Texas, United States
West Virginia University Hospitals /ID# 239593
Morgantown, West Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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M21-432
Identifier Type: -
Identifier Source: org_study_id
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