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
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 |
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).
- - 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).
- - All female participants must have a negative serum pregnancy test (beta-human chorionic gonadotropin [β-hCG]) prior to enrollment into the study.
- - Participant is willing and has an understanding and ability to fully comply with study procedures and restrictions defined in this protocol.
- - 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.
- - 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).
- - 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).
- - 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).
- - 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
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. |
NCT02605837 |
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. |
Study Director |
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) |
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.
Status
Address
Children's Hospital
Birmingham, Alabama, 35233
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Bozeman Health Deaconess Hospital
Bozeman, Montana, 59718
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Phoenix Childrens Hospital
Phoenix, Arizona, 85016
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Del Sol Research Management
Tucson, Arizona, 85710
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Adobe Clinical Research LLC
Tucson, Arizona, 85712
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Arkansas Gastroenterology
North Little Rock, Arkansas, 72117
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GW Research, Inc.
Chula Vista, California, 91910
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Rady Children's Hospital San Diego
San Diego, California, 92123
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Colorado Children's Hospital
Aurora, Colorado, 80045
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Address
Asthma and Allergy Associates PC
Colorado Springs, Colorado, 80907
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Rocky Mountain Pediatric Gastroenterology
Lone Tree, Colorado, 80124
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Rocky Mountain Clinical Research LLC
Wheat Ridge, Colorado, 80033
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Connecticut Clinical Research Foundation
Bristol, Connecticut, 06010
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Connecticut GI, PC - Research Division
Farmington, Connecticut, 06032
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Connecticut Children's Medical Center
Hartford, Connecticut, 06106
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Nature Coast Clinical Research LLC
Inverness, Florida, 34452
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Address
Borland Groover Clinic
Jacksonville, Florida, 32256
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Address
Arnold Palmer Hospital For Children
Orlando, Florida, 32806
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Address
Accord Clinical Research LLC
Port Orange, Florida, 32129
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Address
Children's Center for Digestive Health Care
Atlanta, Georgia, 30342
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Address
Gastroenterology Associates of Central Georgia, LLC
Macon, Georgia, 31201
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Address
Gastrointestinal Specialists of Georgia
Marietta, Georgia, 30060
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Address
Grand Teton Research Group, PLLC
Idaho Falls, Idaho, 83404
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Address
Ann and Robert H Lurie Childrens Hospital of Chicago
Chicago, Illinois, 60611
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Address
Northwestern University
Chicago, Illinois, 60611
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Address
Center for Children's Digestive Health
Park Ridge, Illinois, 60068
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Address
University of Illinois College of Medicine at Peoria Pediatric Subspecialty Clinic
Peoria, Illinois, 61603
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Address
OSF St Francis Medical Center
Peoria, Illinois, 61637
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Address
Indiana University
Indianapolis, Indiana, 46202
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Address
Gastroenterology of Southern Indiana
New Albany, Indiana, 47150
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Address
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
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Address
Cotton O'Neil Clinical Research Center
Topeka, Kansas, 66606
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Address
Gastroenterology Associates LLC
Baton Rouge, Louisiana, 70809
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Address
Clinical Trials Management LLC
Metairie, Louisiana, 70006
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Address
Louisiana Research Center LLC
Shreveport, Louisiana, 71105
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Address
Clinical Trials of America LA LLC - PPDS
West Monroe, Louisiana, 71291
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Address
Tufts Medical Center
Boston, Massachusetts, 00211
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Address
Boston Children's Hospital
Boston, Massachusetts, 02115
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Address
Brigham and Womens Hospital
Boston, Massachusetts, 02115
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Address
University of Michigan
Ann Arbor, Michigan, 48109
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Address
Clinical Research Institute of Michigan
Chesterfield, Michigan, 48047
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Address
West Michigan Clinical Research
Wyoming, Michigan, 49519
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Address
University of Minnesota
Minneapolis, Minnesota, 55454
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Address
Minnesota Gastroenterology PA
Plymouth, Minnesota, 55446
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Address
Mayo Clinic
Rochester, Minnesota, 55905
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Address
South Jersey Gastroenterology
Marlton, New Jersey, 08053
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Address
Long Island Gastrointestinal Research Group LLP
Great Neck, New York, 11023
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Address
Mount Sinai Hospital
New York, New York, 10029
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Address
Asheville Gastroenterology Associates PA
Asheville, North Carolina, 28801
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Address
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
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Address
Clinical Research of Charlotte
Charlotte, North Carolina, 28277
Status
Address
Clinical Trials of America-NC, LLC - PPDS
Mount Airy, North Carolina, 27030
Status
Address
Consultants For Clinical Research Inc
Cincinnati, Ohio, 45219
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Address
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
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Address
University of Cincinnati
Cincinnati, Ohio, 45267
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Address
Cleveland Clinic
Cleveland, Ohio, 44195
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Address
Gastrointestinal and Liver Diseases Consultants PC
Dayton, Ohio, 45415
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Address
Great Lakes Gastroenterology
Mentor, Ohio, 44060
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Address
Digestive Disease Specialists, Inc.
Oklahoma City, Oklahoma, 73112
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Address
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
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Address
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
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Address
Greenville Hospital System
Greenville, South Carolina, 29605
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Address
Greenville Hospital System
Greenville, South Carolina, 29615
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Address
Gastro One
Germantown, Tennessee, 38138
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Address
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
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Address
San Antonio Military Medical Center
Fort Sam Houston, Texas, 78234
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Address
Baylor College of Medicine
Houston, Texas, 77030
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Address
Houston Endoscopy and Research Center
Houston, Texas, 77079
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Address
Digestive Health Center
Pasadena, Texas, 77505
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Address
Texas Digestive Disease Consultants
Southlake, Texas, 76092
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Address
Advanced Research Institute
Ogden, Utah, 84092
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Address
Primary Children's Hospital, University of Utah
Salt Lake City, Utah, 84113
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Address
Advanced Research Institute
Sandy, Utah, 84092
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Address
Emeritas Research Group
Lansdowne Town Center, Virginia, 20176
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Address
Blue Ridge Medical Research
Lynchburg, Virginia, 24502
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Address
Carilion Clinic
Roanoke, Virginia, 24013
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Address
University of Wisconsin
Madison, Wisconsin, 53792