Page Title
Clinical Trial Finder
Nutritional-GI Enrolling
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.
Email a research coordinator to express interest in participating in this study.
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 a more comprehensive list of eligibility criteria and details on this study, 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
-
Enrolling
Florida
Central Florida Pulmonary Group, Orlando, FL 32803
Contact
Kathleen Summo
Phone: +1 (407) 841-1100
Email: ksummo@cfpulmonary.com
-
Closed to Enrollment
Massachusetts
University of Massachusetts Memorial Health Care, Worcester, MA 01655
-
Enrolling
New Hampshire
Dartmouth Hitchcock Medical Center, Lebanon, NH 03756
Contact
Barbara Rodgers
Phone: +1 (603) 650-9718
Email: Barbara.A.Rodgers@hitchcock.org
-
Enrolling
North Carolina
Wake Forest University Baptist Medical Center, Winston-Salem, NC 27157
Contact
Kay Powell
Phone: +1 (336) 713-8559
Email: kapowell@wakehealth.edu
-
Enrolling
Ohio
University of Cincinnati Medical Center, Cincinnati, OH 45267
Contact
Nicole Hummel
Phone: +1 (513) 558-7036
Email: hummelne@ucmail.uc.edu
-
Closed to Enrollment
Ohio
Cleveland Clinic Cystic Fibrosis Program, Cleveland, OH 44195
-
Enrolling
Ohio
Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center, Cleveland, OH 44106
Contact
Primary RC & Participant Contact General Contact
Phone: +1
Email: RainbowCFResearch@UHhospitals.org
-
Enrolling Soon
Texas
Baylor College of Medicine, Houston, TX 77030
Contact
Katie Howe
Phone: +1 (832) 822-4252
Email: klhowe@texaschildrens.org
-
Enrolling Soon
Virginia
Virginia Commonwealth University, Richmond, VA 23298
Contact
Akilah Pierre-Louis
Phone: +1
Email: akilah.pierrelouis1@vcuhealth.org
-
Enrolling Soon
West Virginia
West Virginia University - Morgantown, Morgantown, WV 26507
Contact
Tammy Clark
Phone: +1 (304) 293-5264
Email: tclark@hsc.wvu.edu
Email a research coordinator to express interest in participating in this study.
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 a more comprehensive list of eligibility criteria and details on this study, 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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