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Study Name: Efficacy and Safety of Ultrase MT20 in Children with CF and Pancreatic Insufficiency
Study Type: Interventional
Intervention Category: Nutritional-GI Therapies
Study Sponsor: Axcan
Study Phase: 3
Recruitment Status: Trial Completed
Study Drug(s): Ultrase MT20
Number of Participants Being Recruited: 8
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
This study is being conducted to demonstrate the efficacy and safety of ULTRASE MT20 in children with CF and pancreatic insufficiency, following the new FDA guidelines.
ELIGIBILITY
Age: 7 Years - 11 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.
FOR MORE INFORMATION:
Sponsor Contact Information: Grondin, Josee
(450) 467-5138 X2428
JGrondin@axcan.com
Trial Specific Link on ClinicalTrials.gov: http://www.clinicaltrials.gov/ct2/show/NCT00513682?term=cystic+fibrosis&rank=13
Clinical Research Terms Glossary: Click here
PARTICIPATING SITES:
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.
MI
  • University of Michigan Health System (Pediatric), Ann Arbor, MI, 48109
    Contact Information:
        Kruse, Dawn
        Phone: (734) 615-3266
        Email: dmkruse@umich.edu
OH
  • University Hospitals Case Medical Center/Rainbow Babies and Children's Hospital (Pediatric), Cleveland, OH, 44106
    Contact Information:
        Ksenich, Roberta (Bobbi)
        Phone: (216) 844-5733
        Email: Roberta.Ksenich@UHHospitals.org
PA
  • Hershey Medical Center Pennsylvania State University (Pediatric), Hershey, PA, 17033
    Contact Information:
        Kitch, Diane
        Phone: (717) 531-5646
        Email: dkitch@psu.edu
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