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.

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

Study Purpose

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

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

  • - 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.
Exclusion Criteria
  • - Participant has any condition or abnormality (including laboratory abnormalities), current or past, that, in the opinion of the principal investigator or medical monitor, would compromise the safety of the participant or interfere with or complicate the assessment of signs or symptoms of EoE.
Such conditions may include psychiatric problems; neurologic deficits or disease; developmental delay; cardiovascular, metabolic, or pulmonary disease; or previous gastroesophageal surgery. These should be discussed with the medical monitor.
  • - Participant has used immunomodulatory therapy within 8 weeks prior to the qualifying EGD or between the qualifying EGD and baseline visit (Visit 1) or anticipates using immunomodulatory therapy during the treatment period (except for any ongoing regimen of allergy shots).
Use of long-acting immunomodulatory therapy (for example, Rituxan) within 3 months of the qualifying EGD should be reviewed with the medical monitor.
  • - Participant has been using swallowed topical corticosteroid for EoE or systemic corticosteroid for any condition within the 4 weeks prior to the qualifying EGD, between the qualifying EGD and baseline visit (Visit 1), or anticipates use during the treatment period; any temporary use (less than or equal to [<=]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 the final EGD.
  • - Participant has been on inhaled steroids and has not been on stable treatment for >=3 months prior to screening visit (Visit -1).
Participants on inhaled steroids need to stay on a stable treatment during study participation. Participant has been on intranasal steroids and has not been on stable treatment for a minimum of 4 weeks prior to the qualifying EGD. After the qualifying EGD, participants with seasonal allergic rhinitis may resume (or discontinue) intranasal corticosteroids based on the participant's usual treatment regimen for allergy season.
  • - Participant has initiated, discontinued, or changed dosage regimen of PPIs, H2 antagonists, antacids, or leukotriene inhibitors for any condition (such as gastroesophageal reflux disease, asthma or allergic rhinitis) within the 4 weeks prior to the qualifying EGD, between the qualifying EGD and baseline visit (Visit 1), or anticipates changes in the use of such medications during the treatment period.
  • - Participant has been using cytochrome P450 3A4 (CYP450 3A4) inhibitors (for example, ketoconazole, grapefruit juice) within the 2 weeks prior to the baseline visit (Visit 1) or within 5 half-lives (whichever is greater) or anticipates using such medications during the treatment period.
  • - Participant has an appearance on qualifying 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 (for example, with an insertion tube diameter of greater than [>]9 millimeter [mm]).
  • - Participant is on a pure liquid diet or the 6-food elimination diet.
  • - Participant has had an esophageal dilation within the 3 months prior to screening (Visit -1).
  • - Participant has presence of esophageal varices at the screening endoscopy.
  • - Participant has any current disease of the gastrointestinal tract, aside from EoE, including eosinophilic gastritis, enteritis, colitis, or proctitis; inflammatory bowel disease; or celiac disease.
  • - Participant has other diseases causing or associated with EoE, including hypereosinophilic syndrome, collagen vascular disease, vasculitis, achalasia, or parasitic infection.
  • - Participant has current evidence of oropharyngeal or esophageal candidiasis.
  • - Participant has a potentially serious acute or chronic viral infection or immunodeficiency condition, including tuberculosis, fungal, bacterial, viral/parasite infection, ocular herpes simplex, herpes esophagitis, or chicken pox/measles.
  • - Participant has upper gastrointestinal bleeding within 4 weeks prior to the screening visit (Visit - 1) or between the screening visit and baseline visit (Visit 1).
  • - Participant has evidence of active infection with Helicobacter pylori.
  • - Participant has evidence of unstable asthma within 4 weeks prior to the screening visit (Visit -1) and between the screening visit and baseline visit (Visit 1).
  • - Participant is female and pregnant or nursing.
  • - Participant has a history of intolerance, hypersensitivity, or idiosyncratic reaction to budesonide (or any other corticosteroids) or to any other ingredients of the investigational product.
  • - Participant has taken part and received intervention in an interventional study related to EoE (except for an interventional study for a topical swallowed steroid) within 6 months prior to the screening visit (Visit -1), or any investigational study within 30 days prior to the screening visit (Visit -1).
An investigational topical swallowed steroid must have been discontinued at least 30 days prior to the screening visit (Visit -1).
  • - Participant has a history or high risk of noncompliance with treatment or regular clinic visits.
  • - Participant has previously completed, discontinued, or withdrawn from this study.
  • - Participant has participated in a previous clinical study involving oral budesonide suspension (OBS) (SHP621).
  • - Participant anticipates using sucralfate during the study.

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:
NCT02605837

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
Study Director
Principal Investigator Affiliation Shire

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

Agency Class
Industry
Overall Status Active, not 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

Address

Children's Hospital

Birmingham, Alabama, 35233

Phoenix Childrens Hospital, Phoenix, Arizona

Status

Address

Phoenix Childrens Hospital

Phoenix, Arizona, 85016

Del Sol Research Management, Tucson, Arizona

Status

Address

Del Sol Research Management

Tucson, Arizona, 85710

Adobe Clinical Research LLC, Tucson, Arizona

Status

Address

Adobe Clinical Research LLC

Tucson, Arizona, 85712

Arkansas Gastroenterology, North Little Rock, Arkansas

Status

Address

Arkansas Gastroenterology

North Little Rock, Arkansas, 72117

GW Research, Inc., Chula Vista, California

Status

Address

GW Research, Inc.

Chula Vista, California, 91910

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

Status

Address

Rady Children's Hospital San Diego

San Diego, California, 92123

Colorado Children's Hospital, Aurora, Colorado

Status

Address

Colorado Children's Hospital

Aurora, Colorado, 80045

Asthma and Allergy Associates PC, Colorado Springs, Colorado

Status

Address

Asthma and Allergy Associates PC

Colorado Springs, Colorado, 80907

Lone Tree, Colorado

Status

Address

Rocky Mountain Pediatric Gastroenterology

Lone Tree, Colorado, 80124

Rocky Mountain Clinical Research LLC, Wheat Ridge, Colorado

Status

Address

Rocky Mountain Clinical Research LLC

Wheat Ridge, Colorado, 80033

Connecticut Clinical Research Foundation, Bristol, Connecticut

Status

Address

Connecticut Clinical Research Foundation

Bristol, Connecticut, 06010

Connecticut GI, PC - Research Division, Farmington, Connecticut

Status

Address

Connecticut GI, PC - Research Division

Farmington, Connecticut, 06032

Connecticut Children's Medical Center, Hartford, Connecticut

Status

Address

Connecticut Children's Medical Center

Hartford, Connecticut, 06106

Nature Coast Clinical Research LLC, Inverness, Florida

Status

Address

Nature Coast Clinical Research LLC

Inverness, Florida, 34452

Borland Groover Clinic, Jacksonville, Florida

Status

Address

Borland Groover Clinic

Jacksonville, Florida, 32256

Arnold Palmer Hospital For Children, Orlando, Florida

Status

Address

Arnold Palmer Hospital For Children

Orlando, Florida, 32806

Accord Clinical Research LLC, Port Orange, Florida

Status

Address

Accord Clinical Research LLC

Port Orange, Florida, 32129

Atlanta, Georgia

Status

Address

Children's Center for Digestive Health Care

Atlanta, Georgia, 30342

Macon, Georgia

Status

Address

Gastroenterology Associates of Central Georgia, LLC

Macon, Georgia, 31201

Gastrointestinal Specialists of Georgia, Marietta, Georgia

Status

Address

Gastrointestinal Specialists of Georgia

Marietta, Georgia, 30060

Grand Teton Research Group, PLLC, Idaho Falls, Idaho

Status

Address

Grand Teton Research Group, PLLC

Idaho Falls, Idaho, 83404

Chicago, Illinois

Status

Address

Ann and Robert H Lurie Childrens Hospital of Chicago

Chicago, Illinois, 60611

Northwestern University, Chicago, Illinois

Status

Address

Northwestern University

Chicago, Illinois, 60611

Center for Children's Digestive Health, Park Ridge, Illinois

Status

Address

Center for Children's Digestive Health

Park Ridge, Illinois, 60068

Peoria, Illinois

Status

Address

University of Illinois College of Medicine at Peoria Pediatric Subspecialty Clinic

Peoria, Illinois, 61603

OSF St Francis Medical Center, Peoria, Illinois

Status

Address

OSF St Francis Medical Center

Peoria, Illinois, 61637

Indiana University, Indianapolis, Indiana

Status

Address

Indiana University

Indianapolis, Indiana, 46202

Gastroenterology of Southern Indiana, New Albany, Indiana

Status

Address

Gastroenterology of Southern Indiana

New Albany, Indiana, 47150

University of Iowa Hospitals and Clinics, Iowa City, Iowa

Status

Address

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242

Cotton O'Neil Clinical Research Center, Topeka, Kansas

Status

Address

Cotton O'Neil Clinical Research Center

Topeka, Kansas, 66606

Gastroenterology Associates LLC, Baton Rouge, Louisiana

Status

Address

Gastroenterology Associates LLC

Baton Rouge, Louisiana, 70809

Clinical Trials Management LLC, Metairie, Louisiana

Status

Address

Clinical Trials Management LLC

Metairie, Louisiana, 70006

Louisiana Research Center LLC, Shreveport, Louisiana

Status

Address

Louisiana Research Center LLC

Shreveport, Louisiana, 71105

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

Status

Address

Clinical Trials of America LA LLC - PPDS

West Monroe, Louisiana, 71291

Tufts Medical Center, Boston, Massachusetts

Status

Address

Tufts Medical Center

Boston, Massachusetts, 00211

Boston Children's Hospital, Boston, Massachusetts

Status

Address

Boston Children's Hospital

Boston, Massachusetts, 02115

Brigham and Womens Hospital, Boston, Massachusetts

Status

Address

Brigham and Womens Hospital

Boston, Massachusetts, 02115

University of Michigan, Ann Arbor, Michigan

Status

Address

University of Michigan

Ann Arbor, Michigan, 48109

Clinical Research Institute of Michigan, Chesterfield, Michigan

Status

Address

Clinical Research Institute of Michigan

Chesterfield, Michigan, 48047

West Michigan Clinical Research, Wyoming, Michigan

Status

Address

West Michigan Clinical Research

Wyoming, Michigan, 49519

University of Minnesota, Minneapolis, Minnesota

Status

Address

University of Minnesota

Minneapolis, Minnesota, 55454

Minnesota Gastroenterology PA, Plymouth, Minnesota

Status

Address

Minnesota Gastroenterology PA

Plymouth, Minnesota, 55446

Mayo Clinic, Rochester, Minnesota

Status

Address

Mayo Clinic

Rochester, Minnesota, 55905

Bozeman Health Deaconess Hospital, Bozeman, Montana

Status

Address

Bozeman Health Deaconess Hospital

Bozeman, Montana, 59718

South Jersey Gastroenterology, Marlton, New Jersey

Status

Address

South Jersey Gastroenterology

Marlton, New Jersey, 08053

Great Neck, New York

Status

Address

Long Island Gastrointestinal Research Group LLP

Great Neck, New York, 11023

Mount Sinai Hospital, New York, New York

Status

Address

Mount Sinai Hospital

New York, New York, 10029

Asheville Gastroenterology Associates PA, Asheville, North Carolina

Status

Address

Asheville Gastroenterology Associates PA

Asheville, North Carolina, 28801

Chapel Hill, North Carolina

Status

Address

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514

Clinical Research of Charlotte, Charlotte, North Carolina

Status

Address

Clinical Research of Charlotte

Charlotte, North Carolina, 28277

Mount Airy, North Carolina

Status

Address

Clinical Trials of America-NC, LLC - PPDS

Mount Airy, North Carolina, 27030

Consultants For Clinical Research Inc, Cincinnati, Ohio

Status

Address

Consultants For Clinical Research Inc

Cincinnati, Ohio, 45219

Cincinnati, Ohio

Status

Address

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

University of Cincinnati, Cincinnati, Ohio

Status

Address

University of Cincinnati

Cincinnati, Ohio, 45267

Cleveland Clinic, Cleveland, Ohio

Status

Address

Cleveland Clinic

Cleveland, Ohio, 44195

Dayton, Ohio

Status

Address

Gastrointestinal and Liver Diseases Consultants PC

Dayton, Ohio, 45415

Great Lakes Gastroenterology, Mentor, Ohio

Status

Address

Great Lakes Gastroenterology

Mentor, Ohio, 44060

Digestive Disease Specialists, Inc., Oklahoma City, Oklahoma

Status

Address

Digestive Disease Specialists, Inc.

Oklahoma City, Oklahoma, 73112

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania

Status

Address

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

University of Pennsylvania, Philadelphia, Pennsylvania

Status

Address

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Greenville Hospital System, Greenville, South Carolina

Status

Address

Greenville Hospital System

Greenville, South Carolina, 29605

Greenville Hospital System, Greenville, South Carolina

Status

Address

Greenville Hospital System

Greenville, South Carolina, 29615

Gastro One, Germantown, Tennessee

Status

Address

Gastro One

Germantown, Tennessee, 38138

Vanderbilt University Medical Center, Nashville, Tennessee

Status

Address

Vanderbilt University Medical Center

Nashville, Tennessee, 37212

San Antonio Military Medical Center, Fort Sam Houston, Texas

Status

Address

San Antonio Military Medical Center

Fort Sam Houston, Texas, 78234

Baylor College of Medicine, Houston, Texas

Status

Address

Baylor College of Medicine

Houston, Texas, 77030

Houston Endoscopy and Research Center, Houston, Texas

Status

Address

Houston Endoscopy and Research Center

Houston, Texas, 77079

Digestive Health Center, Pasadena, Texas

Status

Address

Digestive Health Center

Pasadena, Texas, 77505

Texas Digestive Disease Consultants, Southlake, Texas

Status

Address

Texas Digestive Disease Consultants

Southlake, Texas, 76092

Advanced Research Institute, Ogden, Utah

Status

Address

Advanced Research Institute

Ogden, Utah, 84092

Salt Lake City, Utah

Status

Address

Primary Children's Hospital, University of Utah

Salt Lake City, Utah, 84113

Advanced Research Institute, Sandy, Utah

Status

Address

Advanced Research Institute

Sandy, Utah, 84092

Emeritas Research Group, Lansdowne Town Center, Virginia

Status

Address

Emeritas Research Group

Lansdowne Town Center, Virginia, 20176

Blue Ridge Medical Research, Lynchburg, Virginia

Status

Address

Blue Ridge Medical Research

Lynchburg, Virginia, 24502

Carilion Clinic, Roanoke, Virginia

Status

Address

Carilion Clinic

Roanoke, Virginia, 24013

University of Wisconsin, Madison, Wisconsin

Status

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.