Phase
Condition
Esophageal Disorders
Heartburn
Heartburn (Pediatric)
Treatment
APT-1011 3 mg HS
Clinical Study ID
Ages > 12 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male or female ≥12 years of age at the time of informed consent
- Signed ICF and willing and able to adhere to all procedures; signed assent form andparent/guardian ICF must also be collected for adolescents
- Confirmed medical history of EoE
- Adult and adolescent patients who are unable or ineligible to enroll in an APT-1011clinical study or have failed available treatment options
- Willing and able to adhere to the treatment regimen and visit schedule
Exclusion
Exclusion Criteria:
- Have known contraindication, hypersensitivity, or intolerance to corticosteroids
- Have signs and symptoms of adrenal suppression or hypercorticism
- Use of potent CYP3A4 inhibitors (e.g., ritonavir and ketoconazole) are prohibited
- Have current alcohol or drug abuse in the opinion of the Investigator
- Female patients who are pregnant, breastfeeding, or planning to become pregnant whileparticipating in the program
- Female patients of child-bearing potential who are unable to comply with adequatecontraception use during the program
Study Design
Study Description
Connect with a study center
Del Sol Research Management LLC
Tucson, Arizona 85715
United StatesPlanned
Arkansas Gastroenterology
North Little Rock, Arkansas 72117
United StatesPlanned
Camarillo Endoscopy Center
Camarillo, California 93012
United StatesPlanned
Ventura County Gastroenterology Medical Group Camarillo
Camarillo, California 93012
United StatesPlanned
FOMAT Medical Research
Glendale, California 91204
United StatesPlanned
United Medical Doctors
Murrieta, California 92563
United StatesPlanned
Medical Associates Research Group
San Diego, California 92123
United StatesPlanned
Peak Gastroenterology Associates
Colorado Springs, Colorado 80907
United StatesPlanned
Western States Clinical Research Inc
Wheat Ridge, Colorado 80033
United StatesPlanned
Nuvance Health Medical Practice Ct, Inc.
Danbury, Connecticut 06810
United StatesPlanned
Western Connecticut Health Network
Danbury, Connecticut 006810
United StatesPlanned
Medical Research Center of Connecticut
Hamden, Connecticut 06518-3694
United StatesPlanned
Nature Coast Clinical Research
Inverness, Florida 34452
United StatesPlanned
Endoscopic Research, Inc.
Orlando, Florida 32803
United StatesPlanned
Summit Clinical Research
Athens, Georgia 30607
United StatesPlanned
Riley Children's Hospital at Indiana University Health
Peoria, Illinois 61637
United StatesSite Not Available
University of Iowa Hospitals and Clinics
Iowa City, Iowa 52242
United StatesPlanned
MGG Group Co., Inc.
Chevy Chase, Maryland 20815
United StatesPlanned
Gastro Center of Maryland
Columbia, Maryland 21045
United StatesPlanned
Boston Specialists
Boston, Massachusetts 02111
United StatesPlanned
Clinical Research Institute of Michigan LLC
Chesterfield, Michigan 48047
United StatesPlanned
Henry Ford Health System
Novi, Michigan 48377
United StatesPlanned
Henry Ford Medical Center
Novi, Michigan 48377
United StatesPlanned
West Michigan Clinical Research Center
Wyoming, Michigan 49519
United StatesPlanned
MNGI Digestive Health, P.A.
Minneapolis, Minnesota 55413
United StatesPlanned
Minnesota Gastroenterology PA Plymouth Endoscopy Center Clinic
Plymouth, Minnesota 55446
United StatesPlanned
Clinical Research Professionals
Chesterfield, Missouri 63005
United StatesPlanned
Bozeman Health Clinical Research
Bozeman, Montana 59715
United StatesPlanned
Clinical and Translational Research Center (CTRC)
Chapel Hill, North Carolina 27599
United StatesPlanned
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599
United StatesPlanned
Carolina Research
Greenville, North Carolina 27834
United StatesPlanned
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio 45236
United StatesPlanned
Gastro Health Research
Cincinnati, Ohio 45219
United StatesPlanned
Great Lakes Gastroenterology
Mentor, Ohio 44060
United StatesPlanned
Northshore Gastroenterology Research LLC
Westlake, Ohio 44145
United StatesPlanned
Vital Prospects Clinical Research Institute, P.C.
Tulsa, Oklahoma 74136
United StatesPlanned
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesPlanned
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesPlanned
Digestive Disease Associates LTD
Wyomissing, Pennsylvania 19610
United StatesPlanned
Regional Gastroenterology Associates of Lancaster, Ltd.
Wyomissing, Pennsylvania 19610
United StatesPlanned
Rapid City Medical Center LLP
Rapid City, South Dakota 57701
United StatesPlanned
GI Alliance
Garland, Texas 75044
United StatesPlanned
Digestive Health Associates of Texas-Rockwall
Richardson, Texas 75082
United StatesSite Not Available
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