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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
History of Changes

April 9, 2009
May 12, 2010
April 2009
November 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00880100 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Use of Ultrase MT12 in Young Cystic Fibrosis Children
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

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.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cystic Fibrosis
  • Pancreatic Insufficiency
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.
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.
Intervention: Drug: Pancrelipase
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
November 2009
November 2009   (final data collection date for primary outcome measure)

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.
Both
2 Years to 6 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00880100
UMT12CF08-01
Yes
Josée Grondin, Clinical Research Scientist, Axcan Pharma Inc.
Axcan Pharma
Not Provided
Study Chair: Michael W Konstan, MD Rainbow Babies and Children's Hospital -Cystic Fibrosis Center, Cleveland, OH
Axcan Pharma
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP