OBS in Adolescent and Adults With EOE: A Phase II, Randomized, Double-Blind, Placebo Controlled, Study With an Open Label Extension

PHASE2CompletedINTERVENTIONAL
Enrollment

93

Participants

Timeline

Start Date

July 23, 2012

Primary Completion Date

October 30, 2014

Study Completion Date

October 30, 2014

Conditions
Eosinophilic Esophagitis (EoE)
Interventions
DRUG

Oral Budesonide Suspension (MB-9)

OBS suspension to be taken bid over a 16 week course of double blind therapy and OBS suspension to be taken qd to bid during a 24 week optional open label extension period

DRUG

Placebo

Trial Locations (23)

19104

University of Pennsylvania, Philadelphia

24013

Carilion Pediatric Gastroenterology, Roanoke

27599

University of North Carolina at Chapel Hill, Chapel Hill

29615

Children's Center for Digestive Health, Greenville

30342

Children's Center for Digestive Healthcare, Atlanta

37232

Vanderbilt University Medical Center, Nashville

44060

Great Lakes Gastroenterology, Mentor

45229

The Cincinnati Center for Eosinophilic Disorders, Cincinnati

46202

Indiana University Health University Hospital, Indianapolis

Riley Hospital for Children, Indianapolis

52242

University of Iowa Hospitals and Clinics, Iowa City

55905

The Mayo Clinic, Rochester

60068

Center for Children's Digestive Health, Park Ridge

60611

Northwestern Scool of Medicine, Chicago

60614

Children's Memorial Hospital, Chicago

80045

The Children's Hospital, Aurora

84132

University of Utah Healthcare, Salt Lake City

85016

Phoenix Children's Hospital, Phoenix

92123

UCSD Rady Children's Hospital, San Diego

92868

Children's Hospital of Orange County, Orange

02111

Tufts Medical Center, Boston

02115

Children's Hospital Boston, Boston

02903

Rhode Island Hospital, Providence

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY