Efficacy and Safety of Pancrelipase Delayed Release Capsules in Young Children with CF
Study Type:
Interventional
Intervention Category:
Nutritional-GI Therapies
Study Sponsor:
AbbVie
Study Phase:
3
Recruitment Status:
Trial Completed
Study Drug(s):
Creon
Number of Participants Being Recruited:
18
Single / Multi-Center:
Multi-Center
STUDY BACKGROUND INFORMATION:
Pancreatic enzyme replacement therapy is important for normal growth and development in children with CF who have pancreatic insufficiency. The use and safety of current enzyme replacement therapy has been shown in other clinical trials in CF patients with pancreatic insufficiency. This study will look at the use and safety of a new formulation of an enzyme replacement therapy and its effect on fat absorption in CF patients with pancreatic insufficiency.
ELIGIBILITY
Age:
1 Months - 6 Years
FEV1:
Not Applicable
P. aeruginosa status:
Not applicable
B. cepacia status:
Not applicable
Other Primary Eligibility Requirements:
Note: Detailed eligibility criteria information may be available on clinicaltrials.gov. If a specific
trial listing for this trial is available, a link to the specific clinicaltrials.gov listing will be present in the "More Information" section below.
The sites listed below are currently recruiting subjects. Please note that this list generally lists either the pediatric or adult program but not both even though both programs may be recruiting subjects. Also, this list does not include sites that may be participating in the study but are not yet open for recruitment. If you are interested in this study please contact your center for more information.
ID
Saint Luke's Cystic Fibrosis Center of Idaho (Pediatric), Boise, ID, 83712
Contact Information:
Durham, Dixie Phone: (208) 381-7334 Email: durhamd@slhs.org
KY
University of Louisville (Pediatric), Louisville, KY, 40202
Contact Information:
Tomazin, Janet Phone: (502) 852-3772 Email: jmtoma01@louisville.edu
MI
Children's Hospital of Michigan (Pediatric), Detroit, MI, 48201
Contact Information:
Van Wagnen, Catherine Phone: (313) 745-4737 Email: cvanwag@med.wayne.edu
Oklahoma Cystic Fibrosis Center (Pediatric), Oklahoma City, OK, 73104
Contact Information:
Fox, Jodie Phone: (405) 271-6216 Email: Jodie-Fox@ouhsc.edu
PA
Hershey Medical Center Pennsylvania State University (Pediatric), Hershey, PA, 17033
Contact Information:
Kitch, Diane Phone: (717) 531-5646 Email: dkitch@psu.edu
