36
Participants
Start Date
November 30, 2006
Primary Completion Date
April 30, 2007
Study Completion Date
April 30, 2007
Ultrase® MT20
Ultrase® MT 20 capsules containing enteric-coated minitablets orally daily at a dose stabilized during the first stabilization period (4 days), as per investigator's discretion, for 6 to 7 days in either first intervention period or second intervention period.
Placebo
Placebo matched to Ultrase® MT 20 capsules orally daily for 6 to 7 days in either first intervention period or second intervention period.
Pennsylvania State University, The Milton S. Hershey Medical Center, Hershey
Rainbow Babies & Children's Hospital, Cleveland
DeVos Children's Hospital, Grand Rapids
University of Utah Health Sciences Center, Salt Lake City
Lead Sponsor
Forest Laboratories
INDUSTRY