Phase
Condition
Esophageal Disorders
Heartburn (Pediatric)
Heartburn
Treatment
Vonoprazan
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
The participant is ≥18 years of age at the time of informed consent signing.
In the opinion of the investigator or subinvestigators, the participant is capableof understanding and complying with protocol requirements, including completion andcompliance with the electronic diary. The diary must be completed on at least 11 ofthe last 14 days in the 2 weeks prior to Visit 2 (Day -1).
The participant signs and dates a written informed consent form (ICF) and anyrequired privacy authorization prior to the initiation of any study procedures.
The participant has a peak eosinophil count of at least 15 eos/hpf [X 400] from atleast 2 of the 3 esophageal levels on screening endoscopy as measured in at least 6biopsies, at least 2 each from the proximal, mid, and distal segments of theesophagus based on central reading.
The participant has 4 or more days with dysphagia episodes documented via electronicdiary in the 2 weeks prior to Visit 2 (Day -1).
The participant must remain on a stable diet for at least 6 weeks prior to theScreening Period and is expected to remain on a stable diet during the course of thestudy; stable diet is defined as not initiating new elimination diets orreintroducing previously eliminated foods.
A female participant of childbearing potential who is or may be sexually active witha non-sterilized male partner agrees to routinely use adequate contraception fromthe signing of informed consent until 4 weeks after the last dose of study drug.
Exclusion
Exclusion Criteria:
The participant is on a pure liquid diet.
The participant has documented erosive esophagitis at the screening endoscopy.
The participant has other known causes of esophageal eosinophilia or either of thefollowing conditions: hypereosinophilic syndrome, or eosinophilic granulomatosiswith polyangiitis (Churg-Strauss Syndrome).
The participant has a documented diagnosis of eosinophilic gastritis, duodenitis,jejunitis, ileitis, proctitis, or colitis.
The participant has endoscopic Barrett's esophagus (>1 cm of columnar-linedesophagus) or dysplastic changes in the esophagus.
The participant has a history of achalasia, Crohn's disease, ulcerative colitis, orceliac disease.
The participant has a known active Helicobacter pylori infection.
The participant has any other clinically significant structural conditions affectingthe esophagus, including: esophageal varices, viral or fungal infection, and historyof radiation therapy, radiofrequency ablation, endoscopic mucosal resection,cryotherapy to the esophagus, caustic or physiochemical trauma (includingsclerotherapy or esophageal variceal band ligation), or esophageal surgery.
The participant has a history of surgery or non-EoE endoscopic intervention, such asgastric bypass, fundoplication, gastric sleeve, or a history of gastric or duodenalsurgery (except endoscopic removal of benign polyps).
The participant has gastric ulcer(s) or duodenal ulcer(s) within 4 weeks before thefirst dose of study drug.
The participant has had clinically significant upper or lower gastrointestinalbleeding within 4 weeks prior to the Screening Period.
The participant has esophageal stricture(s) unable to be passed with an 8 to 10 mmendoscope, clinically requires dilation, or has a history of dilation within the 3months prior to the Screening Period.
Use of prescription or non-prescription PPIs or PCABs within 2 months prior to theScreening Period.
Use of swallowed topical corticosteroid or budesonide oral suspension for EoE within 2 months prior to the Screening Period.
Use of systemic corticosteroid for any condition within 3 months prior to theScreening Period.
Use of inhaled or nasal glucocorticoids within 3 months prior to the ScreeningPeriod, except stable dose for at least 3 months prior to the Screening Period forany condition (should not be changed during the study).
Use of dupilumab within 3 months prior to the Screening Period.
The participant has received any investigational compound within 30 days or anyinvestigational biologic within 3 months prior to the start of the Screening Period (including those in post-marketing studies) or vonoprazan in a clinical trial at anytime. A participant who has been screen failed from another clinical study and whohas not been dosed may be considered for enrollment in this study.
The participant has used immunomodulatory therapy within 3 months prior to theScreening Period or anticipates using immunomodulatory therapy during the study (except for any ongoing regimen of allergy therapy).
The participant is a study site employee, an immediate family member, is in adependent relationship with a study site employee who is involved in the conduct ofthis study (eg, spouse, parent, child, sibling), or who may have consented underduress.
The participant has a history of hypersensitivity or allergies to vonoprazan (including the formulation excipients: D-mannitol, microcrystalline cellulose,hydroxypropyl cellulose, ascorbic acid, fumaric acid, croscarmellose sodium,magnesium stearate, hypromellose, macrogol 8000, titanium oxide, or red ferricoxide). Skin testing may be performed according to local standard practice toconfirm hypersensitivity.
The participant has a history of alcohol abuse, illegal drug use, drug addiction orregularly consumes alcohol within the 12 months prior to the Screening Period (basedon self-report). Participants must have a negative urine drug screen fornon-prescribed medications at screening. Participants taking prescription drugs willbe allowed. Occasional, recreational use of cannabis is allowed. However,participants with a cannabis use disorder (eg, frequent use, functional-socialimpairment, withdrawal symptoms) per the opinion of the investigator should beexcluded.
The participant is taking any excluded medications or treatments listed in theprotocol.
If female, the participant is pregnant, lactating, or intending to become pregnantbefore, during, or within 4 weeks after participating in this study, or intending todonate ova during such time period.
The participant has a history or clinical manifestations of significant centralnervous system, cardiovascular, pulmonary, metabolic, other gastrointestinal,urological, endocrine, or hematological disease that, in the opinion of theinvestigator, would confound the study results or compromise participant safety.
The participant has a history of malignancy (including MALToma) or has been treatedfor malignancy within 5 years prior to the start of the Screening Period (Visit 1).The participant may be included in the study if he/she has recovered from cutaneousbasal cell carcinoma or cervical carcinoma in situ.
The participant has acquired immunodeficiency syndrome or human immunodeficiencyvirus infection, or tests positive for the hepatitis B surface antigen, hepatitis Cvirus (HCV) antibody, or HCV-ribonucleic acid (RNA). However, participants who testpositive for HCV antibody but negative for HCV-RNA are permitted to participate.
The participant has Zollinger-Ellison syndrome or other gastric acid hypersecretoryconditions.
The participant requires hospitalization or has surgery scheduled during the courseof the study or has undergone major surgical procedures within 30 days prior to theScreening Period.
The participant has moderate to severe hepatic impairment (Child-Pugh Class B andChild-Pugh Class C).
The participant has severe renal impairment (estimated glomerular filtration rate <30 mL/min).
The participant has any of the following abnormal laboratory test values at thestart of the Screening Period:
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 × theupper limit of normal (ULN) or total bilirubin >2 × ULN (except participantswith Gilbert Syndrome).
Creatinine levels: >2 mg/dL (>177 μmol/L)
- The participant is refractory to prior PPI therapy as judged by the investigator.
Study Design
Connect with a study center
Preferred Research Partners, Inc
Little Rock, Arkansas 72211
United StatesActive - Recruiting
Preferred Research Partners, Inc
Little Rock 4119403, Arkansas 4099753 72211
United StatesSite Not Available
GW Research, Inc
Chula Vista, California 91910
United StatesActive - Recruiting
Southern California Research Institute Medical Group
Los Angeles, California 90045
United StatesSite Not Available
GW Research, Inc
Chula Vista 5336899, California 5332921 91910
United StatesSite Not Available
Southern California Research Institute Medical Group
Los Angeles 5368361, California 5332921 90045
United StatesSite Not Available
Rocky Mountain Gastroenterology
Lakewood, Colorado 80228
United StatesActive - Recruiting
Western States Clinical Research, Inc.
Wheat Ridge, Colorado 80033
United StatesActive - Recruiting
Rocky Mountain Gastroenterology
Lakewood 5427946, Colorado 5417618 80228
United StatesSite Not Available
Western States Clinical Research, Inc.
Wheat Ridge 5443948, Colorado 5417618 80033
United StatesSite Not Available
Connecticut Clinical Research Institute
Bristol, Connecticut 06010
United StatesActive - Recruiting
Connecticut Clinical Research Institute
Bristol 5282835, Connecticut 4831725 06010
United StatesSite Not Available
Nature Coast Clinical Research
Inverness, Florida 34452
United StatesActive - Recruiting
Encore Borland-Groover Clinical Research
Jacksonville, Florida 32256
United StatesActive - Recruiting
International Center for Research
Tampa, Florida 33614
United StatesActive - Recruiting
Nature Coast Clinical Research
Inverness 4159786, Florida 4155751 34452
United StatesSite Not Available
Encore Borland-Groover Clinical Research
Jacksonville 4160021, Florida 4155751 32256
United StatesSite Not Available
International Center for Research
Tampa 4174757, Florida 4155751 33614
United StatesSite Not Available
Gastroenterology Associates of Central Georgia, LLC
Macon, Georgia 31201
United StatesActive - Recruiting
Gastroenterology Associates of Central Georgia, LLC
Macon 4207400, Georgia 4197000 31201
United StatesSite Not Available
Treasure Valley Medical Research
Boise, Idaho 83706
United StatesActive - Recruiting
Grand Teton Research Group
Idaho Falls, Idaho 83404
United StatesActive - Recruiting
Treasure Valley Medical Research
Boise 5586437, Idaho 5596512 83706
United StatesSite Not Available
Grand Teton Research Group
Idaho Falls 5596475, Idaho 5596512 83404
United StatesSite Not Available
Northwestern Medicine Digestive Health Center
Chicago, Illinois 60611
United StatesActive - Recruiting
GI Alliance - Gurnee
Gurnee, Illinois 60031
United StatesActive - Recruiting
Northwestern Medicine Digestive Health Center
Chicago 4887398, Illinois 4896861 60611
United StatesSite Not Available
GI Alliance - Gurnee
Gurnee 4894861, Illinois 4896861 60031
United StatesSite Not Available
Combined Gastro, LLC
Lafayette, Louisiana 70503
United StatesActive - Recruiting
Tandem Clinical Research GI, LLC
Marrero, Louisiana 70072
United StatesActive - Recruiting
Combined Gastro, LLC
Lafayette 4330145, Louisiana 4331987 70503
United StatesSite Not Available
Tandem Clinical Research GI, LLC
Marrero 4332628, Louisiana 4331987 70072
United StatesSite Not Available
Woodholme Gastroenterology Associates
Glen Burnie, Maryland 21061
United StatesActive - Recruiting
Woodholme Gastroenterology Associates
Glen Burnie 4356188, Maryland 4361885 21061
United StatesSite Not Available
Boston Specialists
Boston, Massachusetts 02111
United StatesActive - Recruiting
Brigham and Women's Hospital
Boston, Massachusetts 02115
United StatesActive - Recruiting
Boston Specialists
Boston 4930956, Massachusetts 6254926 02111
United StatesSite Not Available
Huron Gastroenterology Associates
Ypsilanti, Michigan 48197
United StatesActive - Recruiting
Huron Gastroenterology Associates
Ypsilanti 5015688, Michigan 5001836 48197
United StatesSite Not Available
Advanced Research Institute
Reno, Nevada 89511
United StatesActive - Recruiting
Advanced Research Institute
Reno 5511077, Nevada 5509151 89511
United StatesSite Not Available
Weill Cornell Medicine, New York Presbyterian Hospital
New York, New York 10065
United StatesActive - Recruiting
UNC Clinical & Translational Research Center
Chapel Hill, North Carolina 27514
United StatesActive - Recruiting
UNC Clinical & Translational Research Center
Chapel Hill 4460162, North Carolina 4482348 27514
United StatesSite Not Available
GCGA Physicians, LLC dba/Gastro Health Research
Cincinnati, Ohio 45219
United StatesActive - Recruiting
Great Lakes Gastroenterology Research LLC
Mentor, Ohio 44060
United StatesActive - Recruiting
GCGA Physicians, LLC dba/Gastro Health Research
Cincinnati 4508722, Ohio 5165418 45219
United StatesSite Not Available
Great Lakes Gastroenterology Research LLC
Mentor 5162645, Ohio 5165418 44060
United StatesSite Not Available
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927 19104
United StatesSite Not Available
Galen Medical Group - Galen Digestive Health
Chattanooga, Tennessee 37404
United StatesActive - Recruiting
Quality Medical Research
Nashville, Tennessee 37211
United StatesActive - Recruiting
Galen Medical Group - Galen Digestive Health
Chattanooga 4612862, Tennessee 4662168 37404
United StatesSite Not Available
Quality Medical Research
Nashville 4644585, Tennessee 4662168 37211
United StatesSite Not Available
GI Alliance
Cedar Park, Texas 78613
United StatesActive - Recruiting
The Hospitals of Providence Memorial Campus
El Paso, Texas 79902
United StatesActive - Recruiting
Texas Digestive Specialists
Harlingen, Texas 78550
United StatesActive - Recruiting
Houston Endoscopy and Research Center
Houston, Texas 77079
United StatesActive - Recruiting
Research Physicians Network, LLC
Houston, Texas 77089
United StatesActive - Recruiting
Biopharma Informatic, LLC
McAllen, Texas 78503
United StatesActive - Recruiting
Pearland Physicians
Pearland, Texas 77581
United StatesActive - Recruiting
Gastroenterology Research of San Antonio
San Antonio, Texas 78229
United StatesActive - Recruiting
Texas Gastro Consultants
Tomball, Texas 73375
United StatesActive - Recruiting
GI Alliance
Cedar Park 4679867, Texas 4736286 78613
United StatesSite Not Available
The Hospitals of Providence Memorial Campus
El Paso 5520993, Texas 4736286 79902
United StatesSite Not Available
Texas Digestive Specialists
Harlingen 4696233, Texas 4736286 78550
United StatesSite Not Available
Houston Endoscopy and Research Center
Houston 4699066, Texas 4736286 77079
United StatesSite Not Available
Research Physicians Network, LLC
Houston 4699066, Texas 4736286 77089
United StatesActive - Recruiting
Biopharma Informatic, LLC
McAllen 4709796, Texas 4736286 78503
United StatesSite Not Available
Pearland Physicians
Pearland 4718097, Texas 4736286 77581
United StatesSite Not Available
Gastroenterology Research of San Antonio
San Antonio 4726206, Texas 4736286 78229
United StatesSite Not Available
Texas Gastro Consultants
Tomball 4737094, Texas 4736286 73375
United StatesSite Not Available
Advanced Research Institute
Ogden, Utah 84405
United StatesActive - Recruiting
Care Access - Ogdon
Ogden, Utah 84403
United StatesActive - Recruiting
Advanced Research Institute
Sandy City, Utah 84070
United StatesActive - Recruiting
Advanced Research Institute
Ogden 5779206, Utah 5549030 84405
United StatesActive - Recruiting
Care Access - Ogdon
Ogden 5779206, Utah 5549030 84403
United StatesSite Not Available
Advanced Research Institute
Sandy City 5781061, Utah 5549030 84070
United StatesSite Not Available
Blue Ridge Medical Research
Lynchburg, Virginia 25402
United StatesActive - Recruiting
Blue Ridge Medical Research
Lynchburg 4771075, Virginia 6254928 25402
United StatesSite Not Available

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