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.

Del Sol Research Management, Tucson, Arizona

Status

Recruiting

Address

Del Sol Research Management

Tucson, Arizona, 85710

Site Contact

Elvia Parra

Eparra@delsolresearch.com

520-257-3881

Arkansas Gastroenterology, North Little Rock, Arkansas

Status

Recruiting

Address

Arkansas Gastroenterology

North Little Rock, Arkansas, 72205

Site Contact

Robert Murphy

murphy@arkgi.net

1 866-842-5335

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

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

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

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

Dana Alexander

danaa@dhcla.com

225-231-8783

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

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

Great Lakes Gastroenterology, Mentor, Ohio

Status

Recruiting

Address

Great Lakes Gastroenterology

Mentor, Ohio, 44060

Site Contact

Keith Friedenberg

kafried@roadrunner.com

1 866-842-5335

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

Advanced Research Institute, Ogden, Utah

Status

Recruiting

Address

Advanced Research Institute

Ogden, Utah, 84405

Site Contact

Nephi Georgi

nephi@advresearch.org

801-409-2040

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