A Study in Adolescents and Adults With Eosinophilic Esophagitis (EoE) Measuring Histologic Response and Determine if Reduction in Dysphagia is Achieved

PHASE3CompletedINTERVENTIONAL
Enrollment

318

Participants

Timeline

Start Date

December 7, 2015

Primary Completion Date

January 24, 2019

Study Completion Date

February 15, 2019

Conditions
Eosinophilic Esophagitis (EoE)
Interventions
DRUG

Oral Budesonide Suspension (OBS)

Oral Budesonide Suspension (OBS) 10 milliliter (ml) of 0.2 milligram per milliliter (mg/ml) twice daily up to 16 weeks.

DRUG

Placebo

Oral dose of 10 ml of placebo matched with the experimental drug.

Trial Locations (77)

10029

Mount Sinai Hospital, New York

11023

Long Island Gastrointestinal Research Group LLP, Great Neck

19104

Children's Hospital of Philadelphia, Philadelphia

University of Pennsylvania, Philadelphia

20176

Emeritas Research Group, Lansdowne Town Center

24013

Carilion Clinic, Roanoke

24502

Blue Ridge Medical Research, Lynchburg

27030

Clinical Trials of America-NC, LLC - PPDS, Mount Airy

27514

University of North Carolina at Chapel Hill, Chapel Hill

28277

Clinical Research of Charlotte, Charlotte

28801

Asheville Gastroenterology Associates PA, Asheville

29605

Greenville Hospital System, Greenville

29615

Greenville Hospital System, Greenville

30060

Gastrointestinal Specialists of Georgia, Marietta

30342

Children's Center for Digestive Health Care, Atlanta

31201

Gastroenterology Associates of Central Georgia, LLC, Macon

32129

Accord Clinical Research LLC, Port Orange

32256

Borland Groover Clinic, Jacksonville

32806

Arnold Palmer Hospital For Children, Orlando

34452

Nature Coast Clinical Research LLC, Inverness

35233

Children's Hospital, Birmingham

37212

Vanderbilt University Medical Center, Nashville

38138

Gastro One, Germantown

44060

Great Lakes Gastroenterology, Mentor

44195

Cleveland Clinic, Cleveland

45219

Consultants For Clinical Research Inc, Cincinnati

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

45267

University of Cincinnati, Cincinnati

45415

Gastrointestinal and Liver Diseases Consultants PC, Dayton

46202

Indiana University, Indianapolis

47150

Gastroenterology of Southern Indiana, New Albany

48047

Clinical Research Institute of Michigan, Chesterfield

48109

University of Michigan, Ann Arbor

49519

West Michigan Clinical Research, Wyoming

52242

University of Iowa Hospitals and Clinics, Iowa City

53792

University of Wisconsin, Madison

55446

Minnesota Gastroenterology PA, Plymouth

55454

University of Minnesota, Minneapolis

55905

Mayo Clinic, Rochester

59718

Bozeman Health Deaconess Hospital, Bozeman

60068

Center for Children's Digestive Health, Park Ridge

60611

Ann and Robert H Lurie Childrens Hospital of Chicago, Chicago

Northwestern University, Chicago

61603

University of Illinois College of Medicine at Peoria Pediatric Subspecialty Clinic, Peoria

61637

OSF St Francis Medical Center, Peoria

66606

Cotton O'Neil Clinical Research Center, Topeka

70006

Clinical Trials Management LLC, Metairie

70809

Gastroenterology Associates LLC, Baton Rouge

71105

Louisiana Research Center LLC, Shreveport

71291

Clinical Trials of America LA LLC - PPDS, West Monroe

72117

Arkansas Gastroenterology, North Little Rock

73112

Digestive Disease Specialists, Inc., Oklahoma City

76092

Texas Digestive Disease Consultants, Southlake

77030

Baylor College of Medicine, Houston

77079

Houston Endoscopy and Research Center, Houston

77505

Digestive Health Center, Pasadena

78234

San Antonio Military Medical Center, Fort Sam Houston

80033

Rocky Mountain Clinical Research LLC, Wheat Ridge

80045

Colorado Children's Hospital, Aurora

80124

Rocky Mountain Pediatric Gastroenterology, Lone Tree

80907

Asthma and Allergy Associates PC, Colorado Springs

83404

Grand Teton Research Group, PLLC, Idaho Falls

84092

Advanced Research Institute, Ogden

Advanced Research Institute, Sandy City

84113

Primary Children's Hospital, University of Utah, Salt Lake City

85016

Phoenix Childrens Hospital, Phoenix

85710

Del Sol Research Management, Tucson

85712

Adobe Clinical Research LLC, Tucson

91910

GW Research, Inc., Chula Vista

92123

Rady Children's Hospital San Diego, San Diego

06010

Connecticut Clinical Research Foundation, Bristol

06032

Connecticut GI, PC - Research Division, Farmington

06106

Connecticut Children's Medical Center, Hartford

00211

Tufts Medical Center, Boston

02115

Boston Children's Hospital, Boston

Brigham and Womens Hospital, Boston

08053

South Jersey Gastroenterology, Marlton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY

NCT02605837 - A Study in Adolescents and Adults With Eosinophilic Esophagitis (EoE) Measuring Histologic Response and Determine if Reduction in Dysphagia is Achieved | Biotech Hunter | Biotech Hunter