Use of Ultrase MT12 in Young Cystic Fibrosis Children

This study has been completed.
Sponsor:
Information provided by:
Axcan Pharma
ClinicalTrials.gov Identifier:
NCT00880100
First received: April 9, 2009
Last updated: May 12, 2010
Last verified: May 2010
  Purpose

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.


Condition Intervention Phase
Cystic Fibrosis
Pancreatic Insufficiency
Drug: Pancrelipase
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Axcan Pharma:

Primary Outcome Measures:
  • Proportion of subjects with control of steatorrhea under Ultrase MT12. [ Time Frame: Day 5 to Day 9 of Baseline Phase and Day 15 to Day 19 of Treatment Phase ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Stool frequency,consistency and characteristics under Ultrase MT12. Abdominal complaints under Ultrase MT12. Tolerability of Ultrase MT12. [ Time Frame: At the end of Baseline Phase and the end of Treatment Phase. Tolerability will be assessed throughout the study. ] [ Designated as safety issue: Yes ]

Enrollment: 54
Study Start Date: April 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Usual pancreatic enzymes
The study subjects will remain on their usual pancreatic enzymes therapy during a portion of the study and switch to Ultrase MT12 during the second portion of the study.
Drug: Pancrelipase
Pancrelipase capsules with each meal and snack. The lipase dose will be lower than 2500 UI lipase/kg of body weight per meal or snack.

  Eligibility

Ages Eligible for Study:   2 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00880100

Locations
United States, Colorado
The Children's Hospital
Aurora, Colorado, United States, 80045
United States, Michigan
University of Michigan Health System Cystic Fibrosis Center
Ann Arbor, Michigan, United States, 48109-0212
Helen DeVos Children's Hospital-Spectrum Health Research Department
Grand Rapids, Michigan, United States, 40503
United States, New York
SUNY Upstate Medical University
Syracuse, New York, United States, 13203
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Rainbow Babies and Children's Hospital - Cystic Fibrosis Center
Cleveland, Ohio, United States, 44106
Children's Medical Center of Dayton
Dayton, Ohio, United States, 45404
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Respiratory Diseases of Children and Adolescents
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
Pennsylvania State University and the Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15213
United States, South Dakota
Sanford Children's Specialty Clinic
Sioux Falls, South Dakota, United States, 57117-5039
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84108
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
United States, Wisconsin
UW Hospital and Clinics
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Axcan Pharma
Investigators
Study Chair: Michael W Konstan, MD Rainbow Babies and Children's Hospital -Cystic Fibrosis Center, Cleveland, OH
  More Information

No publications provided

Responsible Party: Josée Grondin, Clinical Research Scientist, Axcan Pharma Inc.
ClinicalTrials.gov Identifier: NCT00880100     History of Changes
Other Study ID Numbers: UMT12CF08-01
Study First Received: April 9, 2009
Last Updated: May 12, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Axcan Pharma:
Steatorrhea
Malabsorption of fat
Pancreatic enzymes
Abdominal pain
Greasy stools

Additional relevant MeSH terms:
Cystic Fibrosis
Exocrine Pancreatic Insufficiency
Fibrosis
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Lung Diseases
Pancreatic Diseases
Pathologic Processes
Respiratory Tract Diseases
Pancreatin
Pancrelipase
Gastrointestinal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014