Use of Ultrase® MT12 in Young Cystic Fibrosis Children (CF)

PHASE3CompletedINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

April 30, 2009

Primary Completion Date

November 30, 2009

Study Completion Date

November 30, 2009

Conditions
Cystic FibrosisPancreatic Insufficiency
Interventions
DRUG

Ultrase® MT12

Ultrase® MT12 capsules will be given orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose not to exceed 10,000 lipase units/kg/day.

Trial Locations (15)

13203

SUNY Upstate Medical University, Syracuse

15213

Children's Hospital of Pittsburgh of UPMC, Pittsburgh

17033

Pennsylvania State University and the Milton S. Hershey Medical Center, Hershey

23298

Virginia Commonwealth University, Richmond

27710

Duke University Medical Center, Durham

40503

Helen DeVos Children's Hospital-Spectrum Health Research Department, Grand Rapids

44106

Rainbow Babies and Children's Hospital - Cystic Fibrosis Center, Cleveland

45404

Children's Medical Center of Dayton, Dayton

53792

UW Hospital and Clinics, Madison

73104

University of Oklahoma Health Sciences Center, Oklahoma City

73112

Respiratory Diseases of Children and Adolescents, Oklahoma City

80045

The Children's Hospital, Aurora

84108

University of Utah, Salt Lake City

48109-0212

University of Michigan Health System Cystic Fibrosis Center, Ann Arbor

57117-5039

Sanford Children's Specialty Clinic, Sioux Falls

Sponsors
All Listed Sponsors
lead

Forest Laboratories

INDUSTRY