19
Participants
Start Date
May 31, 2006
Primary Completion Date
September 30, 2006
Study Completion Date
September 30, 2006
EUR-1008 (APT-1008)
EUR-1008 (APT-1008) Microtabs contained in a capsule will be administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule will be allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
West Virginia Health Sciences Center, Morgantown
Nemours Childrens Clinic, Jacksonville
University of Alabama, Birmingham
Children's Hospital Medical Center, Cincinnati
University of Michigan, Cystic Fibrosis Center, Ann Arbor
University of Iowa, Iowa City
Childrens Memorial Hospital, Chicago
University of Texas, Tyler
University of Utah, Salt Lake City
Children's Hospital of Los Angeles, Los Angeles
Children's Hospital of San Diego, San Diego
Stanford University Medical Center, Palo Alto
Children's Hospital - Oakland, Oakland
University of Florida College of Medicine, Gainsville
Lead Sponsor
Forest Laboratories
INDUSTRY