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Continuation Study With Budesonide Oral Suspension (BOS) for Adolescent and Adult Subjects With Eosinophilic Esophagitis (EoE)

Study Purpose

This is a continuation study of Budesonide Oral Suspension (BOS) in adults and adolescents with Eosinophilic Esophagitis (EoE) who have completed participation in the SHP621-302 extension study. The purpose of this study is to see if BOS is safe and well tolerated over the long-term in adolescents and adults with EoE.

Recruitment Criteria

Accepts Healthy Volunteers

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

No
Study Type

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.

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

Inclusion Criteria:

  • - Subject completed the SHP621-302 (NCT02736409) extension study and is considered by the investigator to potentially benefit from continued BOS investigational treatment.
  • - 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.
  • - Females of childbearing potential must agree to continue acceptable birth control measures (example (eg): abstinence, surgically sterile male partner, stable oral contraceptives, or double-barrier methods) throughout study participation.
  • - Subject is willing and has an understanding and ability to fully comply with study procedures and restrictions as defined in protocol.

Exclusion Criteria:

  • - Subject has changes in medications or diet during the SHP621-302 (NCT02736409) study that could affect participation in this continuation study.
  • - Subject anticipates using swallowed topical corticosteroid for EoE or systemic corticosteroid for any condition 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 should be avoided within 4 weeks of the scheduled esophagogastroduodenoscopy (EGDs).
  • - Subject anticipates use of Cytochrome P450 3A4 inhibitors (eg, ketoconazole, grapefruit juice) during the continuation study.
  • - Subject has an appearance at the EGD at the final treatment evaluation visit of SHP621-302 (NCT02736409) (Visit 8) 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 greater than (>) 9 millimeter [mm]).
  • - Subject has presence of esophageal varices at the EGD at the final treatment evaluation visit (Visit 8) of the SHP621-302 (NCT02736409) study.
  • - 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.
  • - Subject has other diseases causing or associated with esophageal eosinophilia, including hypereosinophilic syndrome, collagen vascular disease, vasculitis, achalasia, or parasitic infection.
  • - 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 8) of the SHP621-302 (NCT02736409) study is not an exclusion as long as the subject is expected to respond to treatment.
  • - Subject has a potentially serious acute or chronic infection or immunodeficiency condition, including tuberculosis, fungal, bacterial, viral/parasite infection, ocular herpes simplex, or chicken pox/measles.
  • - Subject has upper gastrointestinal bleeding identified at the EGD at the final treatment evaluation visit (Visit 8) of the SHP621-302 (NCT02736409) study.
  • - Subject has evidence of active infection with Helicobacter pylori.
  • - Subject has evidence of unstable asthma.
  • - Subject is female and pregnant or nursing.
  • - 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.
- Subject has a history or high risk of noncompliance with treatment or regular clinic visits

Trial Details

Trial ID:

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.

NCT03245840
Phase

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 3
Lead Sponsor

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

Shire
Principal Investigator

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

Shire Physician
Principal Investigator Affiliation Shire
Agency Class

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

Industry
Overall Status Active, not recruiting
Countries United States
Conditions

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

Eosinophilic Esophagitis (EoE)
Arms & Interventions

Arms

Experimental: Budesonide Oral Suspension

Participants will be initiated on 10 milliliter (mL) of Budesonide oral suspension (0.2 milligram/mL) twice daily up to 48 months (Visit 8) or early termination (ET).

Interventions

Drug: - Budesonide oral suspension

Budesonide oral suspension (BOS) 10 mL twice daily

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, 85712

Arkansas Gastroenterology, North Little Rock, Arkansas

Status

Address

Arkansas Gastroenterology

North Little Rock, Arkansas, 72117

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

Denver, Colorado

Status

Address

Rocky Mountain Pediatric Gastroenterology

Denver, Colorado, 80218

Connecticut Clinical Research Foundation, Bristol, Connecticut

Status

Address

Connecticut Clinical Research Foundation

Bristol, Connecticut, 06010

Connecticut Children's Medical Center, Hartford, Connecticut

Status

Address

Connecticut Children's Medical Center

Hartford, Connecticut, 06106

Connecticut GI, Hartford, Connecticut

Status

Address

Connecticut GI

Hartford, Connecticut, 06106

Nature Coast Clinical Research LLC, Inverness, Florida

Status

Address

Nature Coast Clinical Research LLC

Inverness, Florida, 34452

Arnold Palmer Hospital for Children, Orlando, Florida

Status

Address

Arnold Palmer Hospital for Children

Orlando, Florida, 32806

Atlanta, Georgia

Status

Address

Childrens Center For Digestive Healthcare

Atlanta, Georgia, 30342

Macon, Georgia

Status

Address

Gastroenterology Associates of Central Georgia

Macon, Georgia, 31201

Grand Teton Research Group, Idaho Falls, Idaho

Status

Address

Grand Teton Research Group

Idaho Falls, Idaho, 83404

Northwestern University, Chicago, Illinois

Status

Address

Northwestern University

Chicago, Illinois, 60611

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

Indiana University, Louisville, Kentucky

Status

Address

Indiana University

Louisville, Kentucky, 40202

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

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, Chestnut Hill, Massachusetts

Status

Address

Brigham and Womens Hospital

Chestnut Hill, Massachusetts, 02467

Minnesota Gastroenterology PA, Plymouth, Minnesota

Status

Address

Minnesota Gastroenterology PA

Plymouth, Minnesota, 55446

Astoria, New York

Status

Address

Mount Sinai Hospital, Icahn School of Medicine

Astoria, New York, 11102

Great Neck, New York

Status

Address

Long Island Gastrointestinal Research Group LLP

Great Neck, New York, 11023

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

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, 45440

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

Greenville Hospital, Greenville, South Carolina

Status

Address

Greenville Hospital

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

Houston Endoscopy and Research Center, Houston, Texas

Status

Address

Houston Endoscopy and Research Center

Houston, Texas, 77024

Advanced Research Institute, Ogden, Utah

Status

Address

Advanced Research Institute

Ogden, Utah, 84405

Salt Lake City, Utah

Status

Address

Primary Children's Hospital, University of Utah

Salt Lake City, Utah, 84132

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

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