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

Completed · Phase 2 · Has a placebo group

Conditions studied: Eosinophilic Esophagitis (EoE)

In brief

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

Key facts

Study ID

NCT01642212

Run by

Shire

People needed

93

Starts

2012-07-23

Expected to finish

2014-10-30

Last updated by the study team

2021-06-08

Who can join

Age: 11 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Any Medical condition that may compromise the safety of the subjects or interfere with the signs and symptoms of EoE
• Use of immunomodulatory therapy
• Current use of swallowed corticosteroids
• Esophageal strictures,varices or upper GI bleed
• Other current diseases of the GI tract
• Current viral infection or immunodeficiency condition
• Pregnancy
• Hypersensitivity to budesonide
• History of non compliance

Where it is running

• Phoenix Children's Hospital — Phoenix, Arizona, United States
• Children's Hospital of Orange County — Orange, California, United States
• UCSD Rady Children's Hospital — San Diego, California, United States
• The Children's Hospital — Aurora, Colorado, United States
• Children's Center for Digestive Healthcare — Atlanta, Georgia, United States
• Northwestern Scool of Medicine — Chicago, Illinois, United States
• Children's Memorial Hospital — Chicago, Illinois, United States
• Center for Children's Digestive Health — Park Ridge, Illinois, United States
• Indiana University Health University Hospital — Indianapolis, Indiana, United States
• Riley Hospital for Children — Indianapolis, Indiana, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Children's Hospital Boston — Boston, Massachusetts, United States
• The Mayo Clinic — Rochester, Minnesota, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• The Cincinnati Center for Eosinophilic Disorders — Cincinnati, Ohio, United States
• Great Lakes Gastroenterology — Mentor, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• Children's Center for Digestive Health — Greenville, South Carolina, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• University of Utah Healthcare — Salt Lake City, Utah, United States
• Carilion Pediatric Gastroenterology — Roanoke, Virginia, United States

Full record on ClinicalTrials.gov

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