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Study Name: Use of Utrase MT 12 Enzymes in Young Children with CF Related Pancreatic Insufficiency
Study Type: Interventional
Intervention Category: Nutritional-GI Therapies
Study Sponsor: Axcan
Study Phase: 3
Recruitment Status: Trial Completed
Study Drug(s): Ultrase MT12
Number of Participants Being Recruited: 40
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
This study will look at how effective Ultrase MT 12 can minimize excess fat in the bowel movements of children with CF ages 2- 6 years
ELIGIBILITY
Age: 2 Years - 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.
FOR MORE INFORMATION:
Sponsor Contact Information: Grondin, Josee
(450) 467-5138 X2428
JGrondin@axcan.com
Trial Specific Link on ClinicalTrials.gov: http://clinicaltrials.gov/ct2/show/NCT00880100?term=axcan+and+cystic+fibrosis&rank=1
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.
CO
  • Children's Hospital Colorado (Pediatric), Aurora, CO, 80045
    Contact Information:
        Pardee, Churee
        Phone: (720) 777-6162
        Email: churee.pardee@childrenscolorado.org
MI
  • University of Michigan Health System (Pediatric), Ann Arbor, MI, 48109
    Contact Information:
        Kruse, Dawn
        Phone: (734) 615-3266
        Email: dmkruse@umich.edu
  • Helen DeVos Women and Children's Center (Pediatric), Grand Rapids, MI, 49503
    Contact Information:
        Gile, Cynthia
        Phone: (616) 391-6148
        Email: Cynthia.Gile@spectrumhealth.org
NC
  • Duke University Medical Center (Pediatric), Durham, NC, 27710
    Contact Information:
        West, Miranda
        Phone: (919) 684-2281
        Email: miranda.west@duke.edu
NY
  • SUNY Upstate Medical University (Pediatric), Syracuse, NY, 13210
    Contact Information:
        Lindner, Donna
        Phone: (315) 464-7525
        Email: lindnerd@upstate.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
  • Dayton Children's Hospital (Pediatric), Dayton, OH, 45404
    Contact Information:
        Bartosik, Sandy
        Phone: (937) 641-4004
        Email: bartosiks@childrensdayton.org
OK
  • 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
  • Children's Hospital of Pittsburgh of UPMC (Pediatric), Pittsburgh, PA, 15213
    Contact Information:
        Hartigan, Elizabeth
        Phone: (412) 692-7060
        Email: elizabeth.hartigan@chp.edu
SD
  • Sanford Medical Center (Pediatric), Sioux Falls, SD, 57117
    Contact Information:
        Sandman, Carmen
        Phone: (605) 312-1033
        Email: Carmen.Sandman@SanfordHealth.org
VA
  • Virginia Commonwealth University (Pediatric), Richmond, VA, 23235
    Contact Information:
        Ward, Matthew
        Phone: (804) 628-3093
        Email: wardmt@vcu.edu
WI
  • University of Wisconsin (Pediatric), Madison, WI, 53792
    Contact Information:
        Makholm, Linda
        Phone: (608) 262-0340
        Email: Lmakholm@uwhealth.org
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