Oral Budesonide Suspension (OBS) in Adolescent and Adult Subjects (11-40 Years of Age)With Eosinophilic Esophagitis: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study With an Open Label Extension

Status: Completed
Location: See all (23) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a clinical trial to test an experimental drug for the treatment of Eosinophilic Esophagitis (EoE)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 11
Maximum Age: 40
Healthy Volunteers: No
View:

• Males and Females, age 11-40

• Histologic evidence of EoE

• History of clinical symptoms of EoE including dysphagia

• Willing to continue with dietary, environmental or medical therapy

• Ability to read and understand english

• Written Consent

Locations
United States
Arizona
Phoenix Children's Hospital
Phoenix
California
Children's Hospital of Orange County
Orange
UCSD Rady Children's Hospital
San Diego
Colorado
The Children's Hospital
Aurora
Georgia
Children's Center for Digestive Healthcare
Atlanta
Iowa
University of Iowa Hospitals and Clinics
Iowa City
Illinois
Children's Memorial Hospital
Chicago
Northwestern Scool of Medicine
Chicago
Center for Children's Digestive Health
Park Ridge
Indiana
Indiana University Health University Hospital
Indianapolis
Riley Hospital for Children
Indianapolis
Massachusetts
Children's Hospital Boston
Boston
Tufts Medical Center
Boston
Minnesota
The Mayo Clinic
Rochester
North Carolina
University of North Carolina at Chapel Hill
Chapel Hill
Ohio
The Cincinnati Center for Eosinophilic Disorders
Cincinnati
Great Lakes Gastroenterology
Mentor
Pennsylvania
University of Pennsylvania
Philadelphia
Rhode Island
Rhode Island Hospital
Providence
South Carolina
Children's Center for Digestive Health
Greenville
Tennessee
Vanderbilt University Medical Center
Nashville
Utah
University of Utah Healthcare
Salt Lake City
Virginia
Carilion Pediatric Gastroenterology
Roanoke
Time Frame
Start Date: July 23, 2012
Completion Date: October 30, 2014
Participants
Target number of participants: 93
Treatments
Experimental: Oral Budesonide Suspension
Taken once or twice daily for up to 40 weeks
Placebo Comparator: Matching Placebo
Taken once or twice daily for 20 weeks
Sponsors
Leads: Shire

This content was sourced from clinicaltrials.gov

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