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Sponsored by: |
Axcan Pharma |
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Information provided by: | Axcan Pharma |
ClinicalTrials.gov Identifier: | NCT00408317 |
Cystic Fibrosis (CF) is a genetic disease resulting from the inheritance of a defective autosomal recessive gene. It often results in exocrine pancreatic insufficiency (PI) that leads to non-digestion of fats and proteins and finally to malabsorption of these nutrients. The patients need to take pancreatic enzymes to allow absorption of these nutriments and this has contributed to a significant increase in the life span of CF patients.
The purpose of this study is to assess the safety and efficacy of ULTRASE MT20 compared to placebo for the correction of fat and protein malabsorption in patients with CF and PI.
Condition | Intervention | Phase |
---|---|---|
Cystic Fibrosis Exocrine Pancreatic Insufficiency |
Drug: ULTRASE MT20 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Randomized, Double-Blind, Crossover Study to Compare the Safety and Efficacy of ULTRASE MT20 to Placebo for the Correction of Steatorrhea in Patients With Cystic Fibrosis (CF). |
Enrollment: | 37 |
Study Start Date: | November 2006 |
Study Completion Date: | April 2007 |
Ages Eligible for Study: | 7 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
Key Exclusion Criteria:
United States, Michigan | |
DeVos Children's Hospital | |
Grand Rapids, Michigan, United States, 49503 | |
United States, Ohio | |
Rainbow Babies & Children's Hospital | |
Cleveland, Ohio, United States, 44106 | |
United States, Pennsylvania | |
Pennsylvania State University, The Milton S. Hershey Medical Center | |
Hershey, Pennsylvania, United States, 17033 | |
United States, Utah | |
University of Utah Health Sciences Center | |
Salt Lake City, Utah, United States, 84112 |
Principal Investigator: | Michael W Konstan, MD | Rainbow Babies & Children's Hospital, Cleveland, Ohio |
Study Director: | Jean Spénard, Ph.D. | Axcan Pharma Inc., Mont-St-Hilaire, Québec, Canada |
Study ID Numbers: | UMT20CF05-01 |
Study First Received: | December 4, 2006 |
Last Updated: | August 7, 2007 |
ClinicalTrials.gov Identifier: | NCT00408317 |
Health Authority: | United States: Food and Drug Administration |
Digestive System Diseases Genetic Diseases, Inborn Respiratory Tract Diseases Cystic Fibrosis Fibrosis Lung Diseases |
Infant, Newborn, Diseases Pancreatic Diseases Pancrelipase Cystic fibrosis Steatorrhea Exocrine Pancreatic Insufficiency |
Pathologic Processes Therapeutic Uses Gastrointestinal Agents Pharmacologic Actions |