Use of Ultrase MT12 in Young Cystic Fibrosis Children
Information source: Axcan Pharma
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cystic Fibrosis; Pancreatic Insufficiency
Intervention: Pancrelipase (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Axcan Pharma Official(s) and/or principal investigator(s):
Michael W Konstan, MD, Study Chair, Affiliation: Rainbow Babies and Children's Hospital -Cystic Fibrosis Center, Cleveland, OH
Overall contact:
Josée Grondin, M.Sc., Phone: 450-467-5138, Ext: 2428, Email: jgrondin@axcan.com
Summary
Multicenter, explorative phase IIIb study designed to assess the efficacy of Ultrase MT12 in
the control of steatorrhea and clinical signs and symptoms of malabsorption in cystic
fibrosis children with pancreatic insufficiency.
Clinical Details
Official title: Efficacy and Safety of Ultrase MT12 in the Control of Steatorrhea in Cystic Fibrosis (CF) and Pancreatic Insufficient (PI) Children Aged 2 to 6 Years Old
Study design: Treatment, Non-Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: Proportion of subjects with control of steatorrhea under Ultrase MT12.
Secondary outcome: Stool frequency,consistency and characteristics under Ultrase MT12.
Abdominal complaints under Ultrase MT12.
Tolerability of Ultrase MT12.
Eligibility
Minimum age: 2 Years.
Maximum age: 6 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male or female aged 2 to 6 years inclusively.
- Diagnosis of CF based on one or more typical clinical features of CF OR a sibling
with CF OR a positive newborn screening, plus and at least one of the two followings:
- Sweat chloride test ≥60mmol/L on two separate occasions.
- Two identifiable CF-causing mutations.
- Presence of PI as demonstrated by FE-1 test < 100µg/g of stools and treating
currently with pancreatic enzyme supplementation.
- Able to eat a high-fat diet and having a current adequate nutritional status based on
the BMI.
Exclusion Criteria:
- Subject currently receiving or received an Ultrase MT product in the last 30 days.
- Contraindication/hypersensitivity to Ultrase or to any porcine protein.
- Presence of a medical condition known to increase fecal fat loss or that could
compromise study results or the study subject safety.
- History of complete DIOS in the past 6 months OR 2 or more episodes of incomplete
DIOS in the past year.
- Use of medications that can interfere with fat excretion or frequency of bowel
movements.
Locations and Contacts
Josée Grondin, M.Sc., Phone: 450-467-5138, Ext: 2428, Email: jgrondin@axcan.com
The Children's Hospital, Aurora, Colorado 80045, United States; Recruiting
Churee Pardee, Phone: 720-777-6162, Email: pardee.churee@tchden.org
Gloria Martin, Phone: 720-777-2941, Email: martin.gloria@tchden.org
University of Michigan Health System Cystic Fibrosis Center, Ann Arbor, Michigan 48109-0212, United States; Recruiting
Dawn Kruse, Phone: 734-615-3266, Email: dmkruse@umich.edu
Cindy Benedict, Phone: 734-15-1738, Email: cindygra@med.umich.edu
Helen DeVos Children's Hospital-Spectrum Health Research Department, Grand Rapids, Michigan 40503, United States; Recruiting
Teri Crumb, Phone: 616-391-9367, Email: teri.crumb@spectrum-health.org
Thomas Symington, Phone: 616-391-9366, Email: 'Thomas.Symington@spectrum-health.org'
SUNY Upstate Medical University, Syracuse, New York 13203, United States; Recruiting
Donna Lindner, Phone: 315-464-7525, Email: lindnerd@upstate.edu
Duke University Medical Center, Durham, North Carolina 27710, United States; Not yet recruiting
Kathy Auten, Phone: 919-684-2281, Email: kathy.auten@duke.edu
Rainbow Babies and Children's Hospital - Cystic Fibrosis Center, Cleveland, Ohio 44106, United States; Recruiting
Colette Bucur, Phone: 216-844-1902, Email: colette.bucur@uhhospitals.org
Children's Medical Center of Dayton, Dayton, Ohio 45404, United States; Recruiting
Sandy Bartosik, Phone: 937-641-4004, Email: bartosiks@childrensdayton.org
Respiratory Diseases of Children and Adolescents, Oklahoma City, Oklahoma 73112, United States; Recruiting
Teresa Orf, Phone: 405-945-4495, Email: sreyespedpulm@coxinet.net
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma 73104, United States; Recruiting
Jodie Groff, Phone: 405-271-6216, Email: jgroff@ouhsc.edu
Pennsylvania State University and the Milton S. Hershey Medical Center, Hershey, Pennsylvania 17033, United States; Recruiting
Diane Kitch, Phone: 717-531-5646, Email: dkitch@psu.edu
Lisa Allwein, Phone: 717-531-5338, Email: lallwein@hmc.psu.edu
Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania 15213, United States; Recruiting
Elizabeth Hartigan, Phone: 412-692-7060, Email: elizabeth.hartigan@chp.edu
Sanford Children's Specialty Clinic, Sioux Falls, South Dakota 57117-5039, United States; Recruiting
Sandra Kirschbaum, Phone: 605-333-4206, Email: kirschbs@sanfordhealth.org
University of Utah, Salt Lake City, Utah 84108, United States; Recruiting
Sue Griffiths, Phone: 801-587-7457, Email: sue.griffiths@hsc.utah.edu
Virginia Commonwealth University, Richmond, Virginia 23298, United States; Recruiting
Juellisa Gadd, Phone: 804-628-0212, Email: jgadd@vcu.edu
UW Hospital and Clinics, Madison, Wisconsin 53792, United States; Recruiting
Linda Makholm, Phone: 608-262-0340, Email: lm.makholm@uwhealth.org
Additional Information
Starting date: April 2009
Ending date: October 2009
Last updated: July 29, 2009
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