FARE Clinical Trial Finder

Simplify your search for a clinical trial and help researchers discover new therapies. The FARE Clinical Trial Finder links patients with food allergy and healthy, non-patient volunteers to actively recruiting food allergy studies.

An Extension Study to Evaluate Maintenance of Efficacy and Long-term Treatment Effect of Oral Budesonide Suspension (OBS) in Adults and Adolescents With Eosinophilic Esophagitis (EoE)

Study Purpose

This is a multicenter, double- blind extension study of Oral Budesonide Suspension (OBS) in adults and adolescents (11 to 55 years of age, inclusive) with Eosinophilic Esophagitis (EoE) who have completed participation in the SHP621-301 induction study (NCT02605837). The primary objective is to evaluate the maintenance of efficacy of OBS over 36 weeks. Maintenance of efficacy will be measured by the peak eosinophilic count and Dysphagia Symptom Questionnaire (DSQ) score.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Interventional
Eligible Ages 11 Years - 55 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Subject completed SHP621-301 induction study. 2. Subject is able to provide written informed consent (subject, parent or legal guardian and, as appropriate, subject assent) to participate in the study before completing any study-related procedures. 3. Subject is male or female aged 11-55 years, inclusive, at time of consent for SHP621-301 study. 4. Subject is willing and able to continue any dietary therapy, environmental therapy, and/or medical regimens (including gastric acid suppression; see exclusions below) in effect at the screening visit (Visit 0). There should be no changes to these regimens during study participation. 5. All female subjects 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 (eg, abstinence, stable oral contraceptives, or double-barrier methods) throughout study participation and for 30 days following the last dose of investigational product. 6. Subject is willing and has an understanding and ability to fully comply with study procedures including DSQ compliance (completed the DSQ on ≥70% of days in any 2 consecutive weeks of the screening period)and restrictions defined in this protocol

Exclusion Criteria:

1. Subject has changes in medications that could affect the study or diet in the weeks since the final treatment evaluation visit (Visit 4) of the SHP621-301 study. 2. Subject using immunomodulatory therapy since the final treatment evaluation visit (Visit 4) of the SHP621-301 study or anticipated use of immunomodulatory therapy during the treatment period (except for any ongoing regimen of allergy shots); any temporary use (≤7 days) or initiation of new steroid treatment during the study should be documented and discussed with the medical monitor prospectively but cannot occur within 4 weeks of scheduled EGDs. 3. Subject using swallowed topical corticosteroid for EoE or systemic corticosteroid for any condition since the final treatment evaluation visit (Visit 4) of the SHP621-301 study or anticipated use during the treatment period; any temporary use (≤7 days) or initiation of new steroid treatment during the study should be documented and discussed with medical monitor prospectively but cannot occur within the 4 weeks of the scheduled EGDs. 4. Subject on inhaled or intranasal steroids and not on a stable dose between the baseline visit (Visit 1) of the SHP621-301 study and the screening EGD of this study. 5. Subject has initiated, discontinued, or changed dosage regimen of proton pump inhibitors (PPIs), H2 antagonists, antacids, antihistamines, or leukotriene inhibitors for any condition (such as gastroesophageal reflux disease, asthma or allergic rhinitis) since the final treatment evaluation visit (Visit 4) of the SHP621-301 study or anticipated changes in the use of such medications during the treatment period. 6. Subject using Cytochrome P450 3A4 inhibitors (eg, ketoconazole, grapefruit juice) since the final treatment evaluation visit (Visit 4) of the SHP621-301 study or anticipated use of such medications during the treatment period. 7. Subject has an appearance on screening EGD of an esophageal stricture (high grade), as defined by the presence of a lesion that does not allow passage of a diagnostic adult upper endoscope (eg, with an insertion tube diameter of >9mm). 8. Subject is on a pure liquid diet or the six-food elimination diet. 9. Subject has presence of esophageal varices at the EGD at the final treatment evaluation visit (Visit 4) of the SHP621-301 study. 10. Subject has any current disease of the gastrointestinal tract, aside from EoE, including eosinophilic gastritis, enteritis, colitis, or proctitis, inflammatory bowel disease, or celiac disease. 11. Subject has other diseases causing or associated with esophageal eosinophilia, including hypereosinophilic syndrome, collagen vascular disease, vasculitis, achalasia, or parasitic infection. 12. Subject has oropharyngeal or esophageal candidiasis that failed to respond to previous treatment. Diagnosis with oropharyngeal or esophageal candidiasis at or since the final treatment evaluation visit (Visit 4) of the SHP621-301 study is not an exclusion as long as the subject received treatment for candidiasis and is expected to respond to treatment. 13. Subject has acute or chronic infection or immunodeficiency condition, including tuberculosis, fungal, bacterial, viral/parasite infection, ocular herpes simplex, or chicken pox/measles. 14. Subject has upper gastrointestinal bleeding identified in the EGD at the final treatment evaluation visit (Visit 4) of the SHP621-301 study or since the final treatment evaluation visit (Visit 4) of the SHP621-301 study. 15. Subject has evidence of active infection with Helicobacter pylori. 16. Subject has evidence of unstable asthma since the final treatment evaluation visit (Visit 4) of the SHP621-301 study. 17. Subject is female and pregnant or nursing. 18. Subject has a history of intolerance, hypersensitivity, or idiosyncratic reaction to budesonide (or any other corticosteroids), or to any other ingredients of the study medication. 19. Subject has a history or high risk of noncompliance with treatment or regular clinic visits. 20. Subject is on sucralfate or anticipates using sucralfate during the treatment period.

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT02736409

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
Phase 3

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Shire

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Shire Physician
Principal Investigator Affiliation Shire

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Industry
Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Eosinophilic Esophagitis (EoE)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Children's Hospital, Birmingham, Alabama

Status

Not yet recruiting

Address

Children's Hospital

Birmingham, Alabama, 35233

Site Contact

Jennifer Bray

jlbray@uabmc.edu

205-975-2758

Phoenix Childrens Hospital, Phoenix, Arizona

Status

Recruiting

Address

Phoenix Childrens Hospital

Phoenix, Arizona, 85016

Site Contact

Jamie Smith

jsmith3@phoenixchildrens.com

602-933-3020

Del Sol Research Management, Tucson, Arizona

Status

Recruiting

Address

Del Sol Research Management

Tucson, Arizona, 85710

Site Contact

Maria Gallegos

mgallegos@delsolresearch.com

520-257-3881

Adobe Clinical Research LLC, Tucson, Arizona

Status

Recruiting

Address

Adobe Clinical Research LLC

Tucson, Arizona, 85712

Site Contact

Lori Botello

lori@adobegastro.com

520-318-1236

Arkansas Gastroenterology, North Little Rock, Arkansas

Status

Recruiting

Address

Arkansas Gastroenterology

North Little Rock, Arkansas, 72117

Site Contact

Amie Crow

amie@arkgi.net

501-945-9300

GW Research, Inc., Chula Vista, California

Status

Recruiting

Address

GW Research, Inc.

Chula Vista, California, 91910

Site Contact

Gregory Wiener

Rady Children's Hospital San Diego, San Diego, California

Status

Recruiting

Address

Rady Children's Hospital San Diego

San Diego, California, 92123

Site Contact

Maira Suarez

MSuarez2@rchsd.org

858-966-8152

Colorado Children's Hospital, Aurora, Colorado

Status

Recruiting

Address

Colorado Children's Hospital

Aurora, Colorado, 80045

Site Contact

Calies Menard-Katcher

Asthma and Allergy Associates PC, Colorado Springs, Colorado

Status

Recruiting

Address

Asthma and Allergy Associates PC

Colorado Springs, Colorado, 80907

Site Contact

Fellicia Grimes

fgrimes@aacos.com

(719) 473-8330 x6

Lone Tree, Colorado

Status

Recruiting

Address

Rocky Mountain Pediatric Gastroenterology

Lone Tree, Colorado, 80124

Site Contact

Cassie Timm

ctimm.rmpgi@gmail.com

303-790-1515

Rocky Mountain Clinical Research LLC, Wheat Ridge, Colorado

Status

Withdrawn

Address

Rocky Mountain Clinical Research LLC

Wheat Ridge, Colorado, 80033

Connecticut Clinical Research Foundation, Bristol, Connecticut

Status

Recruiting

Address

Connecticut Clinical Research Foundation

Bristol, Connecticut, 06010

Site Contact

Cecile Guttermuth

cgutterm@bristolhospital.org

860-585-3838

Connecticut GI, PC - Research Division, Farmington, Connecticut

Status

Recruiting

Address

Connecticut GI, PC - Research Division

Farmington, Connecticut, 06032

Site Contact

Rachel Tedesco

rtedesco@connecticutgi.org

860-409-4567 #108

Connecticut Children's Medical Center, Hartford, Connecticut

Status

Recruiting

Address

Connecticut Children's Medical Center

Hartford, Connecticut, 06106

Site Contact

Miriam Lincoln

mlincoln@connecticutchildrens.org

860-545-9540

Nature Coast Clinical Research LLC, Inverness, Florida

Status

Recruiting

Address

Nature Coast Clinical Research LLC

Inverness, Florida, 34452

Site Contact

Susan Budzinski

sbudzinski@encoredocs.com

352-341-2100

Arnold Palmer Hospital For Children, Orlando, Florida

Status

Recruiting

Address

Arnold Palmer Hospital For Children

Orlando, Florida, 32806

Site Contact

Linda Tilme,

linda.tilme@orlandohealth.com

321-841-1361

Accord Clinical Research LLC, Port Orange, Florida

Status

Withdrawn

Address

Accord Clinical Research LLC

Port Orange, Florida, 32129

Atlanta, Georgia

Status

Recruiting

Address

Children's Center for Digestive Health Care

Atlanta, Georgia, 30342

Site Contact

Angela Stallworth Stallworth

astallworth@gicareforkids.com

404-503-2279

Macon, Georgia

Status

Recruiting

Address

Gastroenterology Associates of Central Georgia, LLC

Macon, Georgia, 31201

Site Contact

Karen Shadwick

kshadwick@gaocg.com

478-464-2600 #115

Grand Teton Research Group, PLLC, Idaho Falls, Idaho

Status

Recruiting

Address

Grand Teton Research Group, PLLC

Idaho Falls, Idaho,

Site Contact

Ana Goetsch

ana@gtrgi.org

208-528-4256

Northwestern University, Chicago, Illinois

Status

Recruiting

Address

Northwestern University

Chicago, Illinois, 60611

Site Contact

Angelika Zalewski

angelika.zalewski@northwestern.edu

312-695-4054

Peoria, Illinois

Status

Recruiting

Address

University of Illinois College of Medicine at Peoria Pediatric Subspecialty Clinic

Peoria, Illinois, 61603

Indiana University, Indianapolis, Indiana

Status

Recruiting

Address

Indiana University

Indianapolis, Indiana, 46202

Site Contact

Anita Gupta

anigupta@iu.edu

317-948-4272

Aquiant Research, New Albany, Indiana

Status

Recruiting

Address

Aquiant Research

New Albany, Indiana, 47150

Site Contact

Debra Walker

dwalker@aquiant.com

812-206-1702

Gastroenterology of Southern Indiana, New Albany, Indiana

Status

Recruiting

Address

Gastroenterology of Southern Indiana

New Albany, Indiana, 47150

Site Contact

Debra Walker

dwalker@aquiant.com

812-206-1702

University of Iowa Hospitals and Clinics, Iowa City, Iowa

Status

Recruiting

Address

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242

Site Contact

Ethan Hoover

ethan-hoover@uiowa.edu

319-384-9756

Cotton O'Neil Clinical Research Center, Topeka, Kansas

Status

Recruiting

Address

Cotton O'Neil Clinical Research Center

Topeka, Kansas, 66606

Site Contact

Heather Hirst

hhirst@stormontvail.org

785-368-0482

Gastroenterology Associates LLC, Baton Rouge, Louisiana

Status

Recruiting

Address

Gastroenterology Associates LLC

Baton Rouge, Louisiana, 70809

Site Contact

Satyaprasad Alapati

Clinical Trials Management LLC, Metairie, Louisiana

Status

Recruiting

Address

Clinical Trials Management LLC

Metairie, Louisiana, 70006

Site Contact

Rose Roche

rroche@clinicaltrialsmgt.com

504-455-1310

Louisiana Research Center LLC, Shreveport, Louisiana

Status

Recruiting

Address

Louisiana Research Center LLC

Shreveport, Louisiana, 71105

Site Contact

Veronica Greer

vgreer@gis.md

318-213-3453

Clinical Trials of America LA LLC - PPDS, West Monroe, Louisiana

Status

Recruiting

Address

Clinical Trials of America LA LLC - PPDS

West Monroe, Louisiana, 71291

Site Contact

Sandi Garner

sgarner@ctamerica.net

318-355-3702

Tufts Medical Center, Boston, Massachusetts

Status

Recruiting

Address

Tufts Medical Center

Boston, Massachusetts, 02111

Site Contact

Teresa Brown

tbrown6@tuftsmedicalcenter.org

617-636-4941

Brigham and Womens Hospital, Boston, Massachusetts

Status

Recruiting

Address

Brigham and Womens Hospital

Boston, Massachusetts, 02115

Site Contact

Stacey Brown

sbrown25@partners.org

617-732-7432

University of Michigan, Ann Arbor, Michigan

Status

Recruiting

Address

University of Michigan

Ann Arbor, Michigan, 48109

Site Contact

Val Metko

vmetko@med.umich.edu

734-845-5114

Clinical Research Institute of Michigan, Chesterfield, Michigan

Status

Recruiting

Address

Clinical Research Institute of Michigan

Chesterfield, Michigan, 48047

Site Contact

Aaron Ryder Ryder

aryder@researchmi.com

586-598-3329

Minnesota Gastroenterology PA, Plymouth, Minnesota

Status

Recruiting

Address

Minnesota Gastroenterology PA

Plymouth, Minnesota, 55446

Site Contact

Carlie Leyde

carlie.leyde@mngastro.com

612-870-5560

Mayo Clinic, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic

Rochester, Minnesota, 55905

Site Contact

Debra Geno

geno.debra@mayo.edu

507-538-0367

Bozeman Health Deaconess Hospital, Bozeman, Montana

Status

Recruiting

Address

Bozeman Health Deaconess Hospital

Bozeman, Montana, 59718

Site Contact

Chelsea Stewart

cstewart@crgmt.com

406-585-2444

South Jersey Gastroenterology, Marlton, New Jersey

Status

Withdrawn

Address

South Jersey Gastroenterology

Marlton, New Jersey, 08053

Great Neck, New York

Status

Recruiting

Address

Long Island Gastrointestinal Research Group LLP

Great Neck, New York, 11023

Site Contact

Christine Raiser-Vignola

christineraiser@ligiresearch.com

516-482-5976

Asheville Gastroenterology Associates PA, Asheville, North Carolina

Status

Recruiting

Address

Asheville Gastroenterology Associates PA

Asheville, North Carolina, 28801

Chapel Hill, North Carolina

Status

Recruiting

Address

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514

Site Contact

Catherine Bracken

catherine_bracken@med.unc.edu

919-843-7684

Clinical Research of Charlotte, Charlotte, North Carolina

Status

Recruiting

Address

Clinical Research of Charlotte

Charlotte, North Carolina, 28277

Site Contact

Rebecca Schreiner

rschreiner@crcharlotte.com

980-999-2055

Mount Airy, North Carolina

Status

Recruiting

Address

Clinical Trials of America-NC, LLC - PPDS

Mount Airy, North Carolina, 27030

Site Contact

Donna Rice

drice@ctamerica.net

336-768-3456

Consultants For Clinical Research Inc, Cincinnati, Ohio

Status

Recruiting

Address

Consultants For Clinical Research Inc

Cincinnati, Ohio, 45219

Site Contact

Kim Lyons

klyons@ccrstudy.com

513-872-4549

Cincinnati, Ohio

Status

Recruiting

Address

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

Site Contact

Tal Cohen

tal.cohen@cchmc.org

513-803-3078

University of Cincinnati, Cincinnati, Ohio

Status

Recruiting

Address

University of Cincinnati

Cincinnati, Ohio, 45267

Site Contact

Elizabeth Stambrook

liz.stambrook@uchealth.com

513-584-2363

Cleveland Clinic, Cleveland, Ohio

Status

Recruiting

Address

Cleveland Clinic

Cleveland, Ohio, 44195

Site Contact

Paula Freeman-Vida

freemap@ccf.org

216-444-8562

Dayton, Ohio

Status

Recruiting

Address

Gastrointestinal and Liver Diseases Consultants PC

Dayton, Ohio, 45415

Site Contact

Steven Dellon

Great Lakes Gastroenterology, Mentor, Ohio

Status

Recruiting

Address

Great Lakes Gastroenterology

Mentor, Ohio, 44060

Site Contact

Debbie Donohue

ddonohue@glmrx.com

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania

Status

Recruiting

Address

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

Site Contact

Megan Lewis

lewismo@email.chop.edu

215-590-2459

University of Pennsylvania, Philadelphia, Pennsylvania

Status

Recruiting

Address

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Site Contact

Maureen DeMarshall

demarshm@mail.med.upenn.edu

215-349-8546

Greenville Hospital System, Greenville, South Carolina

Status

Completed

Address

Greenville Hospital System

Greenville, South Carolina, 29615

Gastro One, Germantown, Tennessee

Status

Recruiting

Address

Gastro One

Germantown, Tennessee, 38138

Site Contact

Ziad Younes

Vanderbilt University Medical Center, Nashville, Tennessee

Status

Recruiting

Address

Vanderbilt University Medical Center

Nashville, Tennessee, 37212

Site Contact

Tina Higginbotham

tina.higginbotham@vanderbilt.edu

615-322-4643

San Antonio Military Medical Center, Fort Sam Houston, Texas

Status

Recruiting

Address

San Antonio Military Medical Center

Fort Sam Houston, Texas, 78234

Site Contact

Sara De La Cruz

sara.s.delacruz.ctr@mail.mil

210-916-3879

Baylor College of Medicine, Houston, Texas

Status

Withdrawn

Address

Baylor College of Medicine

Houston, Texas, 77030

Houston Endoscopy and Research Center, Houston, Texas

Status

Recruiting

Address

Houston Endoscopy and Research Center

Houston, Texas, 77079

Site Contact

Normie Stewart-Brown

n.stewartbrown@workmail.com

713-932-6446

Digestive Health Center, Pasadena, Texas

Status

Not yet recruiting

Address

Digestive Health Center

Pasadena, Texas, 77505

Site Contact

Steven Fein

Texas Digestive Disease Consultants, Southlake, Texas

Status

Recruiting

Address

Texas Digestive Disease Consultants

Southlake, Texas, 76092

Site Contact

Shawnna Bowers

Primary Children's Hospital, Salt Lake City, Utah

Status

Recruiting

Address

Primary Children's Hospital

Salt Lake City, Utah, 84113

Site Contact

Rebbecca Perez

rebbecca.perez@hsc.utah.edu

801-587-7759

Advanced Research Institute, Sandy, Utah

Status

Completed

Address

Advanced Research Institute

Sandy, Utah, 84092

Emeritas Research Group, Lansdowne Town Center, Virginia

Status

Recruiting

Address

Emeritas Research Group

Lansdowne Town Center, Virginia, 20176

Blue Ridge Medical Research, Lynchburg, Virginia

Status

Recruiting

Address

Blue Ridge Medical Research

Lynchburg, Virginia, 24502

Site Contact

Larry Clark

Carilion Clinic, Roanoke, Virginia

Status

Recruiting

Address

Carilion Clinic

Roanoke, Virginia, 24013

Site Contact

Christy Florow

cmflorow@carilionclinic.org

540-985-9723

University of Wisconsin, Madison, Wisconsin

Status

Withdrawn

Address

University of Wisconsin

Madison, Wisconsin, 53792

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.