Phase
Condition
Esophageal Disorders
Heartburn (Pediatric)
Heartburn
Treatment
Full dose Pantoprazole plus matching placebo
Half Dose Pantoprazole plus matching placebo
Clinical Study ID
Ages 1-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants must have a documented erosive lesion with an Los Angeles (LA) Grade ofA to D prior to starting Proton Pump Inhibitor treatment:
Capable of giving signed informed consent/assent
Willingness and ability of the participant or parent/legal guardian to complete theeDiary
Willing and able to comply with all scheduled visits, treatment plan, laboratorytests, lifestyle considerations, and other study procedures, including the use ofthe eDiary.
Male and female participants aged 1 to 17 years.
Minimum body weight 7 kilogram and weight at least at the 5th percentile per theCenter for Disease Control standard age and weight chart, for the participant's age.
To be considered a female of non childbearing potential, the participant must meetat least 1 of the following criteria :
Premenarchal: The investigator (or other appropriate staff) must discuss theparticipant's premenarchal status with the participant and parent/legal guardian atoffice visits and during telephone contacts, as participants who achieve menarcheduring the study would no longer be considered "female participants of nonchildbearing potential" and must comply with the protocol requirements applicable towomen of childbearing potential.
Exclusion
Exclusion Criteria:
Previous administration of an investigational drug or vaccine within 30 days (or asdetermined by the local requirement) or 5 half-lives preceding the first dose ofstudy intervention used in this study (whichever is longer).
Children that may be at high risk from procedural sedation should be carefullyevaluated. Participants with a history of complications during prior proceduralsedation
History or presence of upper gastrointestinal anatomic or motor disorders
Family history of malignant hyperthermia
Known hypersensitivity to any Proton Pump Inhibitor, including pantoprazole or toany substituted benzimidazole or to any of the excipients.
Any disorder requiring chronic (daily) use of warfarin, heparin, otheranticoagulants, methotrexate, atazanavir or nelfinavir, clopidogrel, or potentinhibitors or inducers of CYP2C19 (eg, phenytoin, sulfamethoxazole, valproic acid,carbamazepine, and griseofulvin).
Serum creatine kinase levels >3 x upper limit of normal.
Known history of human immunodeficiency virus or clinical manifestations of acquiredimmune deficiency syndrome.
Active malignancy of any type, or history of a malignancy. Participants with ahistory of malignancies that have been surgically removed or eradicated byirradiation or chemotherapy and who have no evidence of recurrence for at least 5years before Screening are acceptable.
Diagnosed as having or has received treatment for esophageal, gastric, pyloricchannel, or duodenal ulceration within 30 days before the Screening visit.
Alanine aminotransferase or blood urea nitrogen >2.0 upper limit of normal orestimated creatinine >1.5 X upper limit of normal for age or any other laboratoryabnormality considered by the Investigator to be clinically significant within 14days before the Baseline Visit (Day 1).
Other acute or chronic medical or psychiatric condition including recent (within thepast year) or active suicidal ideation or behavior or laboratory abnormality thatmay increase the risk associated with study participation or study interventionadministration or may interfere with the interpretation of study results and, in thejudgment of the investigator, would make the participant inappropriate for entryinto this study.
Has, in the Investigator's opinion, a serious chronic condition (eg, diabetes,epilepsy), which is either not stable or not well controlled and may interfere withthe conduct of the study.
Has any condition possibly affecting drug absorption (eg, gastrectomy).
Prior or Concomitant Therapy:
Frequent, repeated use of oral or parenteral glucocorticoids (eg, prednisone,prednisolone, dexamethasone). Steroid inhalers and topical steroids may be used.
Pregnant female participants; breastfeeding female participants.
Is unwilling or unable to comply with the Lifestyle Considerations section
Study Design
Study Description
Connect with a study center
UZ Brussel
Brussel, 1090
BelgiumSite Not Available
University clinical center of the Republic of Srpska
Banja Luka, 78000
Bosnia and HerzegovinaSite Not Available
University clinical center of the Republic of Srpska
Banja Luka 3204541, 78000
Bosnia and HerzegovinaSite Not Available
Evex clinic after I. Tsitsishvili
Tbilisi, Georgia
GeorgiaSite Not Available
Georgian-American Family Medicine Clinic
Tbilisi, 0171
GeorgiaSite Not Available
JSC Georgian Clinics
Tbilisi, 0159
GeorgiaSite Not Available
LTD Imedi Clinic
Tbilisi, 0159
GeorgiaSite Not Available
New Hospitals
Tbilisi, 0114
GeorgiaSite Not Available
Pediatric Clinic after G. Zhvania
Tbilisi, 0159
GeorgiaSite Not Available
Evex clinic after I. Tsitsishvili
Tbilisi 611717, Georgia
GeorgiaSite Not Available
Georgian-American Family Medicine Clinic
Tbilisi 611717, 0171
GeorgiaSite Not Available
JSC Georgian Clinics
Tbilisi 611717, 0159
GeorgiaSite Not Available
LTD Imedi Clinic
Tbilisi 611717, 0159
GeorgiaSite Not Available
Szegedi Tudományegyetem
Szeged, Csongrád 6726
HungarySite Not Available
Heim Pal Pediatric Hospital
Budapest, 1089
HungarySite Not Available
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032
HungarySite Not Available
Gujarat Hospital - Gastro & Vascular Centre
Surat, Gujarat 395009
IndiaSite Not Available
Sanjeevani Children's Hospital
Aurangabad, Maharashtra 431005
IndiaSite Not Available
SR Kalla Memorial Gastro & General Hospital
Jaipur, Rajasthan 302001
IndiaSite Not Available
SR Kalla Memorial Gastro & General Hospital
Jaipur 1269515, Rajasthan 1258899 302001
IndiaSite Not Available
Yashoda Hospitals
Secunderabad, Telangana 500003
IndiaSite Not Available
Medical college and Hospital
Kolkata, WEST Bengal 700073
IndiaSite Not Available
Medical college and Hospital
Kolkata 1275004, West Bengal 1252881 700073
IndiaSite Not Available
Hospital HIMA San Pablo Caguas
Caguas, 00725
Puerto RicoSite Not Available
Hospital HIMA San Pablo Caguas
Caguas 4563008, 00725
Puerto RicoSite Not Available
Chiara Biaggi de Casenave, MD
Guaynabo, 00969
Puerto RicoSite Not Available
Chiara Biaggi de Casenave, MD
Guaynabo 4565119, 00969
Puerto RicoSite Not Available
Caribbean Clinical Research, LLC
Ponce, 00716
Puerto RicoSite Not Available
Puerto Rico Consortium for Clinical Investigation
San Juan, 00936-3475
Puerto RicoSite Not Available
University Children's Hospital
Belgrade, 11000
SerbiaSite Not Available
University Children's Hospital
Belgrade 792680, 11000
SerbiaSite Not Available
University Clinical Center of Kragujevac
Kragujevac, 34000
SerbiaSite Not Available
University Clinical Center of Kragujevac
Kragujevac 789128, 34000
SerbiaSite Not Available
Detska fakultna nemocnica s poliklinikou Banska Bystrica
Banska Bystrica, 974 09
SlovakiaSite Not Available
CLINIQ s.r.o.
Bratislava, 811 09
SlovakiaSite Not Available
Narodny ustav detskych chorob
Bratislava, 83340
SlovakiaSite Not Available
Univerzitna nemocnica Martin, Klinika deti a dorastu
Martin, 036 59
SlovakiaSite Not Available
Univerzitna nemocnica Martin, Klinika deti a dorastu
Martin 3058780, 036 59
SlovakiaSite Not Available
KM Management, spol. s r.o.,
Nitra, 94901
SlovakiaSite Not Available
KM Management, spol. s r.o.,
Nitra 3058531, 94901
SlovakiaSite Not Available
SBU Izmir Tepecik EAH
Izmir, 35180
TurkeySite Not Available
T.C. Saglik Bakanligi - Izmir Sehir Hastanesi
Izmir, 35540
TurkeySite Not Available
MDX Klinik Arastirma Egitim ve Danismanlik Ltd
Istanbul 745044, 34880
Turkey (Türkiye)Site Not Available
Izmir Saglik Bilimleri University Tepecik Training And Research Hospital
Izmir 311046, 35340
Turkey (Türkiye)Site Not Available
T.C. Saglik Bakanligi - Izmir Sehir Hastanesi
Izmir 311046, 35540
Turkey (Türkiye)Site Not Available
Queen Mary's Hospital for Children, Epsom and St Helier University Hospitals NHS Trust
Carshalton, SM5 1AA
United KingdomSite Not Available
Evelina London Children's Hospital
London, SE1 7EH
United KingdomSite Not Available
Great Ormond Street Hospital For Children NHS Foundation Trust
London, WC1N 3JH
United KingdomSite Not Available
King's College Hospital NHS Foundation Trust
London, SE5 9RS
United KingdomSite Not Available
Royal Free Hospital
London, NW3 2QG
United KingdomSite Not Available
Evelina London Children's Hospital
London 2643743, SE1 7EH
United KingdomSite Not Available
Great Ormond Street Hospital For Children NHS Foundation Trust
London 2643743, WC1N 3JH
United KingdomSite Not Available
Guys & St Thomas Nhs Foundation
London 2643743, SE1 9RT
United KingdomSite Not Available
King's College Hospital NHS Foundation Trust
London 2643743, SE5 9RS
United KingdomSite Not Available
Childrens Hospital of Orange County
Orange, California 92868
United StatesSite Not Available
Baptist/Wolfson's Children's Hospital
Jacksonville, Florida 32207
United StatesSite Not Available
Nemours Children's Specialty Care
Jacksonville, Florida 32207
United StatesSite Not Available
Baptist/Wolfson's Children's Hospital
Jacksonville 4160021, Florida 4155751 32207
United StatesSite Not Available
Nemours Children's Health, Jacksonville
Jacksonville 4160021, Florida 4155751 32207
United StatesSite Not Available
Children's Healthcare of Atlanta - Center for Advanced Pediatrics
Atlanta, Georgia 30329
United StatesSite Not Available
Children's Healthcare of Atlanta-Egleston
Atlanta, Georgia 30322
United StatesSite Not Available
The University of Chicago Medical Center
Chicago, Illinois 60637
United StatesSite Not Available
Methodist Medical Center of Illinois
Peoria, Illinois 61603
United StatesSite Not Available
Unity Point Health Pediatric Gastroenterology
Peoria, Illinois 61602
United StatesSite Not Available
Mayo Clinic Rochester
Rochester, Minnesota 55905
United StatesSite Not Available
University of Rochester Medical Center
Rochester, New York 14642
United StatesSite Not Available
University of Rochester Medical Center Clinical Research Center
Rochester, New York 14642
United StatesSite Not Available
University of Rochester
Rochester 5134086, New York 5128638 14627
United StatesSite Not Available
University of Rochester Medical Center Clinical Research Center
Rochester 5134086, New York 5128638 14642
United StatesSite Not Available
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania 15224
United StatesSite Not Available
Children's Health / Children's Medical Center
Dallas, Texas 75235
United StatesSite Not Available
Cabell Huntington Hospital Endoscopy Suite (Endoscopy Only)
Huntington, West Virginia 25701
United StatesSite Not Available
University Physicians and Surgeons, Inc dba Marshall Health
Huntington, West Virginia 25701
United StatesSite Not Available
UW Health E Terrace Dr Medical Center
Madison, Wisconsin 53718
United StatesSite Not Available
University Hospital and UW Health Clinics
Madison, Wisconsin 53792
United StatesSite Not Available
UW Health 2275 Deming Way Clinic
Middleton, Wisconsin 53562
United StatesSite Not Available
Board of Regents of the University of Wisconsin System
Madison 5261457, Wisconsin 5279468 53715
United StatesSite Not Available
UW Health E Terrace Dr Medical Center
Madison 5261457, Wisconsin 5279468 53718
United StatesSite Not Available
University Hospital and UW Health Clinics
Madison 5261457, Wisconsin 5279468 53792
United StatesSite Not Available
UW Health 2275 Deming Way Clinic
Middleton 5262838, Wisconsin 5279468 53562
United StatesSite Not Available

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