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.

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

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:

  • - 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

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:
NCT03245840

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.

Blue Ridge Medical Research, Lynchburg, Virginia

Status

Recruiting

Address

Blue Ridge Medical Research

Lynchburg, Virginia, 24502

Site Contact

Site Contact

l.clark@gastrocentralva.com

434-455-8670

Emeritas Research Group, Lansdowne Town Center, Virginia

Status

Recruiting

Address

Emeritas Research Group

Lansdowne Town Center, Virginia, 20176

Site Contact

Site Contact

emeritasrg@gmail.com

703-723-3670 #223

Primary Children's Hospital, Salt Lake City, Utah

Status

Recruiting

Address

Primary Children's Hospital

Salt Lake City, Utah, 84132

Site Contact

Site Contact

molly.ogorman@hsc.utah.edu

801-587-7484

Advanced Research Institute, Ogden, Utah

Status

Recruiting

Address

Advanced Research Institute

Ogden, Utah, 84405

Site Contact

Site Contact

jlowe@advresearch.org

801-409-2040

Houston Endoscopy and Research Center, Houston, Texas

Status

Recruiting

Address

Houston Endoscopy and Research Center

Houston, Texas, 77079

Site Contact

Site Contact

houston_endoscopy@yahoo.com

713-932-6446

Mentor, Ohio

Status

Recruiting

Address

Great Lakes Gastroenterology Research, LLC - ClinEdge - PPDS

Mentor, Ohio, 44060

Site Contact

Site Contact

kafried@roadrunner.com

440-205-1225 #219

Dayton Gastroenterology Inc, Dayton, Ohio

Status

Recruiting

Address

Dayton Gastroenterology Inc

Dayton, Ohio, 45440

Site Contact

Site Contact

sdellon@daytongastro.com

937-320-5050 #3031

University of Cincinnati, Cincinnati, Ohio

Status

Recruiting

Address

University of Cincinnati

Cincinnati, Ohio, 45267

Site Contact

Site Contact

kunnatva@ucmail.uc.edu

513-584-2363

Clinical Research of Charlotte, Charlotte, North Carolina

Status

Recruiting

Address

Clinical Research of Charlotte

Charlotte, North Carolina, 28277

Site Contact

Site Contact

djohnston@asthmanc.com

980-999-2054 #304

Chapel Hill, North Carolina

Status

Recruiting

Address

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514

Site Contact

Site Contact

edellon@med.unc.edu

919-966-7957

Great Neck, New York

Status

Recruiting

Address

Long Island Gastrointestinal Research Group LLP

Great Neck, New York, 11023

Tufts Medical Center, Boston, Massachusetts

Status

Recruiting

Address

Tufts Medical Center

Boston, Massachusetts, 00211

Site Contact

Site Contact

drjohnleung@gmail.com

617-636-2379

Gastroenterology Associates LLC, Baton Rouge, Louisiana

Status

Recruiting

Address

Gastroenterology Associates LLC

Baton Rouge, Louisiana, 70809

Site Contact

Site contact

palapati@tddctx.com

225-927-1190 #7850

Indiana University, Louisville, Kentucky

Status

Recruiting

Address

Indiana University

Louisville, Kentucky, 40202

Site Contact

Site Contact

jmwo@iu.edu

317-948-9227

Cotton O'Neil Clinical Research Center, Topeka, Kansas

Status

Recruiting

Address

Cotton O'Neil Clinical Research Center

Topeka, Kansas, 66606

Site Contact

Site Contact

cubaum@stormontvail.org

785-270-8604

Iowa City, Iowa

Status

Recruiting

Address

University of Iowa Stead Family Children's Hospital

Iowa City, Iowa, 52242

Aquiant Research, New Albany, Indiana

Status

Recruiting

Address

Aquiant Research

New Albany, Indiana, 47150

Site Contact

Site Contact

kysteve2005@yahoo.com

812-206-1702

Northwestern University, Chicago, Illinois

Status

Recruiting

Address

Northwestern University

Chicago, Illinois, 60611

Site Contact

Site Contact

i-hirano@northwestern.edu

312-695-4036

Macon, Georgia

Status

Recruiting

Address

Gastroenterology Associates of Central Georgia, LLC

Macon, Georgia, 31201

Site Contact

Site Contact

gisedghi@aol.com

478-464-2600

Atlanta, Georgia

Status

Recruiting

Address

Childrens Center For Digestive Healthcare

Atlanta, Georgia, 30342

Site Contact

Site Contact

bgold@gicareforkids.com

404-503-2279

Orlando Health, Orlando, Florida

Status

Recruiting

Address

Orlando Health

Orlando, Florida, 32806

Site Contact

Site Contact

yamen.smadi@orlandohealth.com

321-841-1077

Connecticut GI, PC - Research Division, Farmington, Connecticut

Status

Recruiting

Address

Connecticut GI, PC - Research Division

Farmington, Connecticut, 06032

Site Contact

Site Contact

spsillas@connecticutgi.org

860-409-4567 #108

Connecticut Clinical Research Foundation, Bristol, Connecticut

Status

Recruiting

Address

Connecticut Clinical Research Foundation

Bristol, Connecticut, 06010

Site Contact

Site Contact

zakko@bristolhospital.org

860-585-3838

Lone Tree, Colorado

Status

Recruiting

Address

Rocky Mountain Pediatric Gastroenterology

Lone Tree, Colorado, 80124

Site Contact

Site Contact

theodore.stathos@rmpgi.com

303-790-1515

Asthma and Allergy Associates PC - CRN, Colorado Springs, Colorado

Status

Recruiting

Address

Asthma and Allergy Associates PC - CRN

Colorado Springs, Colorado, 80907

Site Contact

Site Contact

dsoteres@aacos.com

719-473-0872

Colorado Children's Hospital, Aurora, Colorado

Status

Recruiting

Address

Colorado Children's Hospital

Aurora, Colorado, 80045

Arkansas Gastroenterology, North Little Rock, Arkansas

Status

Recruiting

Address

Arkansas Gastroenterology

North Little Rock, Arkansas, 72117

Site Contact

Site Contact

murphy@arkgi.net

501-945-9300

Del Sol Research Management, Tucson, Arizona

Status

Recruiting

Address

Del Sol Research Management

Tucson, Arizona, 85712

Site Contact

Site Contact

Ggottlieb@delsolresearch.com

520-257-3881

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.