5
Participants
Start Date
July 31, 2010
Primary Completion Date
February 29, 2012
Study Completion Date
February 29, 2012
ODSH at 0.125 mg/kg/h
ODSH 1000 mg vials containing 20 cc of normal saline (50 mg/ml) to be prepared for 96-h IV infusion with normal saline based on subject's weight and dose assigned by Study Cohort 1 of 0.125 mg/kg/h.
ODSH at 0.375 mg/kg/h
ODSH 1000 mg vials containing 20 cc of normal saline (50 mg/ml) to be prepared for 96-h IV infusion with normal saline based on subject's weight and dose assigned by Study Cohort 3 of 0.375 mg/kg/h.
ODSH at 0.250 mg/kg/h
ODSH 1000 mg vials containing 20 cc of normal saline (50 mg/ml) to be prepared for 96-h IV infusion with normal saline based on subject's weight and dose assigned by Study Cohort 2 of 0.250 mg/kg/h.
Children's Hospital Los Angeles ( Gastroenterology & Nutrition), Los Angeles
Department of Cardiology, Children's Hospital Boston, Boston
Division of Pediatric Cardiology, University of Michigan Health System, Ann Arbor
Sanford Children's ( Sanford Research / USD), Sioux Falls
Lead Sponsor
Jazz Pharmaceuticals
INDUSTRY