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Nutritional-GI Closed to Enrollment
Study to evaluate Creon in adults with cystic fibrosis or chronic pancreatitis (AbbVie M21-432 )
This study will look at the symptoms of exocrine pancreatic insufficiency (EPI) in adults with cystic fibrosis or chronic pancreatitis treated with Creon with an alternate source of active drug. Creon is a drug approved to treat EPI.
In this study, participants will be given oral capsules of Creon for 112 days and will be followed for 30 days. Participants will not know the source of the Creon they are given. Researchers will track symptoms of EPI by performing medical assessments and monitoring side effects.This study may require questionnaires and/or other measurements.
Eligibility
See other primary eligibility criteria for more information.
-
Age:
18 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
No FEV1 Limit
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Participants must have a diagnosis of EPI due to cystic fibrosis or chronic pancreatitis that has been controlled with a stable dose regimen of Creon for more than 3 months before screening.
Study Design
-
Study Type: ?more info
Interventional -
Randomized Study: ?more info
Yes -
Placebo Controlled: ?more info
No -
Length of Participation:
142 days -
Number of Study Visits:
3
Additional Information
-
Phase: ?more info
Phase Four/Post-Approval -
Study Sponsor: ?more info
AbbVie -
Study Drugs:
N/A
Study Sites
-
Closed to Enrollment
Massachusetts
University of Massachusetts Memorial Health Care, Worcester, MA 01655
-
Closed to Enrollment
New Hampshire
Dartmouth Hitchcock Medical Center, Lebanon, NH 03756
-
Closed to Enrollment
North Carolina
Wake Forest University Baptist Medical Center, Winston-Salem, NC 27157
-
Closed to Enrollment
Ohio
University of Cincinnati Medical Center, Cincinnati, OH 45267
-
Closed to Enrollment
Ohio
Cleveland Clinic Cystic Fibrosis Program, Cleveland, OH 44195
-
Closed to Enrollment
Ohio
Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center, Cleveland, OH 44106
-
Closed to Enrollment
Texas
Baylor College of Medicine, Houston, TX 77030
-
Closed to Enrollment
Virginia
Virginia Commonwealth University, Richmond, VA 23298
-
Closed to Enrollment
West Virginia
West Virginia University - Morgantown, Morgantown, WV 26507
Eligibility
See other primary eligibility criteria for more information.
-
Age:
18 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
No FEV1 Limit
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Participants must have a diagnosis of EPI due to cystic fibrosis or chronic pancreatitis that has been controlled with a stable dose regimen of Creon for more than 3 months before screening.
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