Phase
Condition
Heartburn (Pediatric)
Heartburn
Esophageal Disorders
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
BelgiumActive - Recruiting
University clinical center of the Republic of Srpska
Banja Luka, 78000
Bosnia and HerzegovinaTerminated
Evex clinic after I. Tsitsishvili
Tbilisi, Georgia
GeorgiaActive - Recruiting
Georgian-American Family Medicine Clinic
Tbilisi, 0171
GeorgiaActive - Recruiting
JSC Georgian Clinics
Tbilisi, 0159
GeorgiaActive - Recruiting
LTD Imedi Clinic
Tbilisi, 0159
GeorgiaTerminated
New Hospitals
Tbilisi, 0114
GeorgiaActive - Recruiting
Pediatric Clinic after G. Zhvania
Tbilisi, 0159
GeorgiaActive - Recruiting
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
IndiaActive - Recruiting
Yashoda Hospitals
Secunderabad, Telangana 500003
IndiaSite Not Available
Medical college and Hospital
Kolkata, WEST Bengal 700073
IndiaSite Not Available
Hospital HIMA San Pablo Caguas
Caguas, 00725
Puerto RicoActive - Recruiting
Chiara Biaggi de Casenave, MD
Guaynabo, 00969
Puerto RicoActive - Recruiting
Caribbean Clinical Research, LLC
Ponce, 00716
Puerto RicoSite Not Available
Puerto Rico Consortium for Clinical Investigation
San Juan, 00936-3475
Puerto RicoActive - Recruiting
University Children's Hospital
Belgrade, 11000
SerbiaActive - Recruiting
University Clinical Center of Kragujevac
Kragujevac, 34000
SerbiaActive - Recruiting
Detska fakultna nemocnica s poliklinikou Banska Bystrica
Banska Bystrica, 974 09
SlovakiaActive - Recruiting
CLINIQ s.r.o.
Bratislava, 811 09
SlovakiaActive - Recruiting
Narodny ustav detskych chorob
Bratislava, 83340
SlovakiaActive - Recruiting
Univerzitna nemocnica Martin, Klinika deti a dorastu
Martin, 036 59
SlovakiaActive - Recruiting
KM Management, spol. s r.o.,
Nitra, 94901
SlovakiaActive - Recruiting
SBU Izmir Tepecik EAH
Izmir, 35180
TurkeyActive - Recruiting
T.C. Saglik Bakanligi - Izmir Sehir Hastanesi
Izmir, 35540
TurkeyActive - Recruiting
Queen Mary's Hospital for Children, Epsom and St Helier University Hospitals NHS Trust
Carshalton, SM5 1AA
United KingdomActive - Recruiting
Evelina London Children's Hospital
London, SE1 7EH
United KingdomActive - Recruiting
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 KingdomActive - Recruiting
Royal Free Hospital
London, NW3 2QG
United KingdomActive - Recruiting
Childrens Hospital of Orange County
Orange, California 92868
United StatesSite Not Available
Baptist/Wolfson's Children's Hospital
Jacksonville, Florida 32207
United StatesActive - Recruiting
Nemours Children's Specialty Care
Jacksonville, Florida 32207
United StatesActive - Recruiting
Children's Healthcare of Atlanta - Center for Advanced Pediatrics
Atlanta, Georgia 30329
United StatesActive - Recruiting
Children's Healthcare of Atlanta-Egleston
Atlanta, Georgia 30322
United StatesActive - Recruiting
The University of Chicago Medical Center
Chicago, Illinois 60637
United StatesActive - Recruiting
Methodist Medical Center of Illinois
Peoria, Illinois 61636
United StatesActive - Recruiting
Unity Point Health Pediatric Gastroenterology
Peoria, Illinois 61602
United StatesActive - Recruiting
Mayo Clinic Rochester
Rochester, Minnesota 55905
United StatesActive - Recruiting
University of Rochester Medical Center
Rochester, New York 14642
United StatesActive - Recruiting
University of Rochester Medical Center Clinical Research Center
Rochester, New York 14642
United StatesActive - Recruiting
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania 15224
United StatesActive - Recruiting
Children's Health / Children's Medical Center
Dallas, Texas 75235
United StatesActive - Recruiting
Cabell Huntington Hospital Endoscopy Suite (Endoscopy Only)
Huntington, West Virginia 25701
United StatesActive - Recruiting
University Physicians and Surgeons, Inc dba Marshall Health
Huntington, West Virginia 25701
United StatesActive - Recruiting
UW Health E Terrace Dr Medical Center
Madison, Wisconsin 53718
United StatesActive - Recruiting
University Hospital and UW Health Clinics
Madison, Wisconsin 53792
United StatesActive - Recruiting
UW Health 2275 Deming Way Clinic
Middleton, Wisconsin 53562
United StatesActive - Recruiting
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