Phase
Condition
Esophageal Disorders
Heartburn (Pediatric)
Heartburn
Treatment
Budesonide oral suspension
Clinical Study ID
Ages 11-55 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant completed the SHP621-302 (NCT02736409) extension study and is consideredby the investigator to potentially benefit from continued BOS investigationaltreatment.
Participant is able to provide written informed consent (participant, parent orlegal guardian and, as appropriate, participant assent) to participate in the studybefore completing any study-related procedures.
Females of childbearing potential must agree to continue acceptable birth controlmeasures (example (e.g.): abstinence, surgically sterile male partner, stable oralcontraceptives, or double-barrier methods) throughout study participation.
Participant is willing and has an understanding and ability to fully comply withstudy procedures and restrictions as defined in protocol.
Exclusion
Exclusion Criteria:
Participant has changes in medications or diet during the SHP621-302 (NCT02736409)study that could affect participation in this continuation study.
Participant anticipates using swallowed topical corticosteroid for EoE or systemiccorticosteroid for any condition during the treatment period; any temporary use (less than or equal to [≤] 7 days) or initiation of new steroid treatment during thestudy should be documented and discussed with the medical monitor prospectively butshould be avoided within 4 weeks of the scheduled esophagogastroduodenoscopy (EGDs).
Participant anticipates use of Cytochrome P450 3A4 inhibitors (e.g., ketoconazole,grapefruit juice) during the continuation study.
Participant has an appearance at the EGD at the final treatment evaluation visit ofSHP621-302 (NCT02736409) (Visit 8) of an esophageal stricture (high grade), asdefined by the presence of a lesion that does not allow passage of a diagnosticadult upper endoscope (e.g., with an insertion tube diameter of greater than (>) 9millimeter [mm]).
Participant has presence of esophageal varices at the EGD at the final treatmentevaluation visit (Visit 8) of the SHP621-302 (NCT02736409) study.
Participant has any current disease of the gastrointestinal tract, aside from EoE,including eosinophilic gastritis, enteritis, colitis, or proctitis, inflammatorybowel disease, or celiac disease.
Participant has other diseases causing or associated with esophageal eosinophilia,including hypereosinophilic syndrome, collagen vascular disease, vasculitis,achalasia, or parasitic infection.
Participant has oropharyngeal or esophageal candidiasis that failed to respond toprevious treatment. Diagnosis with oropharyngeal or esophageal candidiasis at orsince the final treatment evaluation visit (Visit 8) of the SHP621-302 (NCT02736409)study is not an exclusion as long as the participant is expected to respond totreatment.
Participant has a potentially serious acute or chronic infection or immunodeficiencycondition, including tuberculosis, fungal, bacterial, viral/parasite infection,ocular herpes simplex, or chicken pox/measles.
Participant has upper gastrointestinal bleeding identified at the EGD at the finaltreatment evaluation visit (Visit 8) of the SHP621-302 (NCT02736409) study.
Participant has evidence of active infection with Helicobacter pylori.
Participant has evidence of unstable asthma.
Participant is female and pregnant or nursing.
Participant has a history of intolerance, hypersensitivity, or idiosyncraticreaction to budesonide (or any other corticosteroids), or to any other ingredientsof the study medication.
Participant has a history or high risk of noncompliance with treatment or regularclinic visits.
Study Design
Connect with a study center
Children's Hospital
Birmingham, Alabama 35233
United StatesSite Not Available
Phoenix Childrens Hospital
Phoenix, Arizona 85016
United StatesSite Not Available
Del Sol Research Management
Tucson, Arizona 85712
United StatesSite Not Available
Arkansas Gastroenterology
North Little Rock, Arkansas 72117
United StatesSite Not Available
Rady Children's Hospital San Diego
San Diego, California 92123
United StatesSite Not Available
Colorado Children's Hospital
Aurora, Colorado 80045
United StatesSite Not Available
Asthma and Allergy Associates PC
Colorado Springs, Colorado 80907
United StatesSite Not Available
Rocky Mountain Pediatric Gastroenterology
Denver, Colorado 80218
United StatesSite Not Available
Rocky Mountain Pediatric Gastroenterology
Lone Tree, Colorado 80124
United StatesSite Not Available
Connecticut Clinical Research Foundation
Bristol, Connecticut 06010
United StatesSite Not Available
Connecticut GI, PC - Research Division
Farmington, Connecticut 06032
United StatesSite Not Available
Connecticut Children's Medical Center
Hartford, Connecticut 06106
United StatesSite Not Available
Connecticut GI
Hartford, Connecticut 06106
United StatesSite Not Available
Nature Coast Clinical Research LLC
Inverness, Florida 34452
United StatesSite Not Available
Arnold Palmer Hospital for Children
Orlando, Florida 32806
United StatesSite Not Available
Childrens Center For Digestive Healthcare
Atlanta, Georgia 30342
United StatesSite Not Available
Gastroenterology Associates of Central Georgia
Macon, Georgia 31201
United StatesSite Not Available
Grand Teton Research Group
Idaho Falls, Idaho 83404
United StatesSite Not Available
Northwestern University
Chicago, Illinois 60611
United StatesSite Not Available
Gastroenterology of Southern Indiana
New Albany, Indiana 47150
United StatesSite Not Available
University of Iowa Hospitals and Clinics
Iowa City, Iowa 52242
United StatesSite Not Available
Cotton O'Neil Clinical Research Center
Topeka, Kansas 66606
United StatesSite Not Available
Indiana University
Louisville, Kentucky 40202
United StatesSite Not Available
Gastroenterology Associates, LLC
Baton Rouge, Louisiana 70809
United StatesSite Not Available
Clinical Trials Management LLC
Metairie, Louisiana 70006
United StatesSite Not Available
Boston Children's Hospital
Boston, Massachusetts 02115
United StatesSite Not Available
Tufts Medical Center
Boston, Massachusetts 00211
United StatesSite Not Available
Brigham and Womens Hospital
Chestnut Hill, Massachusetts 02467
United StatesSite Not Available
Minnesota Gastroenterology PA
Plymouth, Minnesota 55446
United StatesSite Not Available
Mount Sinai Hospital, Icahn School of Medicine
Astoria, New York 11102
United StatesSite Not Available
Long Island Gastrointestinal Research Group LLP
Great Neck, New York 11023
United StatesSite Not Available
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27514
United StatesSite Not Available
Clinical Research of Charlotte
Charlotte, North Carolina 28277
United StatesSite Not Available
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
United StatesSite Not Available
University of Cincinnati
Cincinnati, Ohio 45267
United StatesSite Not Available
Cleveland Clinic
Cleveland, Ohio 44195
United StatesSite Not Available
Gastrointestinal and Liver Diseases Consultants PC
Dayton, Ohio 45440
United StatesSite Not Available
Great Lakes Gastroenterology
Mentor, Ohio 44060
United StatesSite Not Available
Digestive Disease Specialists, Inc.
Oklahoma City, Oklahoma 73112
United StatesSite Not Available
Greenville Hospital
Greenville, South Carolina 29615
United StatesSite Not Available
Gastro One
Germantown, Tennessee 38138
United StatesSite Not Available
Vanderbilt University Medical Center
Nashville, Tennessee 37212
United StatesSite Not Available
Houston Endoscopy and Research Center
Houston, Texas 77024
United StatesSite Not Available
Advanced Research Institute
Ogden, Utah 84405
United StatesSite Not Available
Primary Children's Hospital, University of Utah
Salt Lake City, Utah 84132
United StatesSite Not Available
Emeritas Research Group
Lansdowne Town Center, Virginia 20176
United StatesSite Not Available
Blue Ridge Medical Research
Lynchburg, Virginia 24502
United StatesSite Not Available
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