Safety and Efficacy Study of ULTRASE® MT20 in Participants With Cystic Fibrosis (CF) and Exocrine Pancreatic Insufficiency (PI)

PHASE3CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

November 30, 2006

Primary Completion Date

April 30, 2007

Study Completion Date

April 30, 2007

Conditions
Cystic FibrosisExocrine Pancreatic Insufficiency
Interventions
DRUG

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.

DRUG

Placebo

Placebo matched to Ultrase® MT 20 capsules orally daily for 6 to 7 days in either first intervention period or second intervention period.

Trial Locations (4)

17033

Pennsylvania State University, The Milton S. Hershey Medical Center, Hershey

44106

Rainbow Babies & Children's Hospital, Cleveland

49503

DeVos Children's Hospital, Grand Rapids

84112

University of Utah Health Sciences Center, Salt Lake City

Sponsors
All Listed Sponsors
lead

Forest Laboratories

INDUSTRY