Use of Ultrase MT12 in Young Cystic Fibrosis Children
This study has been completed.
Sponsor:
Axcan Pharma
Information provided by:
Axcan Pharma
ClinicalTrials.gov Identifier:
NCT00880100
First received: April 9, 2009
Last updated: May 12, 2010
Last verified: May 2010
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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
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 | |
| Respiratory Diseases of Children and Adolescents | |
| Oklahoma City, Oklahoma, United States, 73112 | |
| University of Oklahoma Health Sciences Center | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| 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 Fibrosis Exocrine Pancreatic Insufficiency Steatorrhea Pancreatic Diseases Digestive System Diseases Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases |
Pathologic Processes Malabsorption Syndromes Intestinal Diseases Gastrointestinal Diseases Metabolic Diseases Pancreatin Pancrelipase Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013