A Safety and Efficacy Study on ULTRASE MT20 in Patients With Cystic Fibrosis (CF) and Exocrine Pancreatic Insufficiency (PI)
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.
Exocrine Pancreatic Insufficiency
Drug: ULTRASE MT20
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|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).|
- Compare the coefficient of fat absorption (CFA) of ULTRASE MT20 to placebo. The CFA will be measured by assessing the dietary fat intake and excretion during a 72-hour period.
- Compare the coefficient of protein absorption (CNA) of ULTRASE MT20 to placebo. The CNA will be measured as the CFA. The safety will be evaluated from the laboratory analyses, the adverse events and the overall signs and symptoms.
|Study Start Date:||November 2006|
|Study Completion Date:||April 2007|
|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|