Oral Budesonide Suspension (OBS) in Adolescent and Adult Subjects (11 to 55 Years of Age, Inclusive) With Eosinophilic Esophagitis: A Phase 3 Randomized, Double-blind, Placebo-controlled Study

Status: Completed
Location: See all (77) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

A study in adolescents and adults with eosinophilic esophagitis (EoE) to measure the histologic response and determine if any reduction in dysphagia is achieved.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 11
Maximum Age: 55
Healthy Volunteers: No
View:

• Participants is able to provide written informed consent (participant, parent or legal guardian, and, as appropriate, participant assent) to participate in the study before completing any study-related procedures.

• Participant is male or female aged 11-55 years, inclusive, at time of consent.

• Participant has histologic evidence of eosinophilic esophagitis (EoE) with a peak eosinophil count of greater than or equal to (>=) 15/ high-powered field (HPF), from 2 of 3 (proximal, mid-, and/or distal) levels of the esophagus at the screening endoscopy.

• Participant has a history of clinical symptoms of esophageal dysfunction (for example, eating problems, abdominal pain, heartburn, dysphagia, vomiting, food impaction, weight loss) intermittently or continuously at screening (Visit -1).

• Participants must have experienced dysphagia (response of yes to question 2 on Dysphagia Symptom Questionnaire [DSQ]) on a minimum of 4 days and completed the DSQ on >= 70 percent (%) of days in any 2 consecutive weeks of the screening period and in the last 2 weeks prior to the baseline visit (Visit 1).

• Participant must not have PPI-responsive EoE based on esophageal biopsies performed after the patient has been on at least 8 weeks of high-dose PPI therapy (high-dose therapy refers to the total daily dose, which may have been administered as a once or twice daily dosing regimen). This may occur at the time of the qualifying esophagogastroduodenoscopy (EGD) (in which case the same proton pump inhibitor (PPI) regimen must be continued), or this may have been done previously (in which case PPI therapy may have been stopped if there was no response to therapy based on esophageal biopsy results). If PPI responsiveness was excluded by a previous EGD and biopsy, the historical EGD and biopsy must have been performed after the patient had been on a minimum of 6 weeks of high-dose PPI therapy.

• Participant will be on a stable (no changes) diet >=3 months prior to the screening visit (Visit -1).

• Participant is willing and able to continue any dietary therapy, environmental therapy, and/or medical regimens (including gastric acid suppression) in effect at the screening visit (Visit -1). There should be no change to these regimens during study participation.

• All female participants must have a negative serum pregnancy test (beta-human chorionic gonadotropin [β-hCG]) prior to enrollment into the study. Females of childbearing potential must agree to continue acceptable birth control measures (for example, abstinence, stable oral contraceptives, or double-barrier methods) throughout study participation.

• Participant is willing and has an understanding and ability to fully comply with study procedures and restrictions defined in this protocol.

Locations
United States
Alabama
Children's Hospital
Birmingham
Arkansas
Arkansas Gastroenterology
North Little Rock
Arizona
Phoenix Childrens Hospital
Phoenix
Adobe Clinical Research LLC
Tucson
Del Sol Research Management
Tucson
California
GW Research, Inc.
Chula Vista
Rady Children's Hospital San Diego
San Diego
Colorado
Colorado Children's Hospital
Aurora
Asthma and Allergy Associates PC
Colorado Springs
Rocky Mountain Pediatric Gastroenterology
Lone Tree
Rocky Mountain Clinical Research LLC
Wheat Ridge
Connecticut
Connecticut Clinical Research Foundation
Bristol
Connecticut GI, PC - Research Division
Farmington
Connecticut Children's Medical Center
Hartford
Florida
Nature Coast Clinical Research LLC
Inverness
Borland Groover Clinic
Jacksonville
Arnold Palmer Hospital For Children
Orlando
Accord Clinical Research LLC
Port Orange
Georgia
Children's Center for Digestive Health Care
Atlanta
Gastroenterology Associates of Central Georgia, LLC
Macon
Gastrointestinal Specialists of Georgia
Marietta
Iowa
University of Iowa Hospitals and Clinics
Iowa City
Idaho
Grand Teton Research Group, PLLC
Idaho Falls
Illinois
Ann and Robert H Lurie Childrens Hospital of Chicago
Chicago
Northwestern University
Chicago
Center for Children's Digestive Health
Park Ridge
OSF St Francis Medical Center
Peoria
University of Illinois College of Medicine at Peoria Pediatric Subspecialty Clinic
Peoria
Indiana
Indiana University
Indianapolis
Gastroenterology of Southern Indiana
New Albany
Kansas
Cotton O'Neil Clinical Research Center
Topeka
Louisiana
Gastroenterology Associates LLC
Baton Rouge
Clinical Trials Management LLC
Metairie
Louisiana Research Center LLC
Shreveport
Clinical Trials of America LA LLC - PPDS
West Monroe
Massachusetts
Boston Children's Hospital
Boston
Brigham and Womens Hospital
Boston
Tufts Medical Center
Boston
Michigan
University of Michigan
Ann Arbor
Clinical Research Institute of Michigan
Chesterfield
West Michigan Clinical Research
Wyoming
Minnesota
University of Minnesota
Minneapolis
Minnesota Gastroenterology PA
Plymouth
Mayo Clinic
Rochester
Montana
Bozeman Health Deaconess Hospital
Bozeman
North Carolina
Asheville Gastroenterology Associates PA
Asheville
University of North Carolina at Chapel Hill
Chapel Hill
Clinical Research of Charlotte
Charlotte
Clinical Trials of America-NC, LLC - PPDS
Mount Airy
New Jersey
South Jersey Gastroenterology
Marlton
New York
Long Island Gastrointestinal Research Group LLP
Great Neck
Mount Sinai Hospital
New York
Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati
Consultants For Clinical Research Inc
Cincinnati
University of Cincinnati
Cincinnati
Cleveland Clinic
Cleveland
Gastrointestinal and Liver Diseases Consultants PC
Dayton
Great Lakes Gastroenterology
Mentor
Oklahoma
Digestive Disease Specialists, Inc.
Oklahoma City
Pennsylvania
Children's Hospital of Philadelphia
Philadelphia
University of Pennsylvania
Philadelphia
South Carolina
Greenville Hospital System
Greenville
Greenville Hospital System
Greenville
Tennessee
Gastro One
Germantown
Vanderbilt University Medical Center
Nashville
Texas
San Antonio Military Medical Center
Fort Sam Houston
Baylor College of Medicine
Houston
Houston Endoscopy and Research Center
Houston
Digestive Health Center
Pasadena
Texas Digestive Disease Consultants
Southlake
Utah
Advanced Research Institute
Ogden
Primary Children's Hospital, University of Utah
Salt Lake City
Advanced Research Institute
Sandy
Virginia
Emeritas Research Group
Lansdowne Town Center
Blue Ridge Medical Research
Lynchburg
Carilion Clinic
Roanoke
Wisconsin
University of Wisconsin
Madison
Time Frame
Start Date: December 7, 2015
Completion Date: February 15, 2019
Participants
Target number of participants: 318
Treatments
Experimental: Oral Budesonide Suspension (OBS)
Participants will receive Oral Budesonide Suspension (OBS) 10 milliliter (ml) of 0.2 milligram per milliliter (mg/ml) twice daily up to 16 weeks.
Placebo Comparator: Placebo
Participants will receive oral dose of 10 ml of placebo matched with the experimental drug twice daily up to 16 weeks.
Sponsors
Leads: Shire

This content was sourced from clinicaltrials.gov

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