Protonix Treatment of Maintenance of Healing in Pediatric Participants Aged 1-11 Years and 12-17 Years

Last updated: October 11, 2024
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

2

Condition

Heartburn (Pediatric)

Heartburn

Esophageal Disorders

Treatment

Full dose Pantoprazole plus matching placebo

Half Dose Pantoprazole plus matching placebo

Clinical Study ID

NCT04821310
B1791094
2023-508770-28-00
2020-005030-15
  • Ages 1-17
  • All Genders

Study Summary

The purpose of this study is to explore the outcomes, tolerability and safety of 2 different doses of oral pantoprazole (full healing dose, half healing dose), assigned based upon weight, for the maintenance of healing of erosive esophagitis in pediatric participants aged 1 to 17 years with endoscopically-confirmed, healed erosive esophagitis.

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

Total Participants: 110
Treatment Group(s): 2
Primary Treatment: Full dose Pantoprazole plus matching placebo
Phase: 2
Study Start date:
January 13, 2022
Estimated Completion Date:
December 09, 2027

Study Description

Explore the outcomes, tolerability and safety of 2 different doses of oral pantoprazole (full healing dose, half healing dose), assigned based upon weight, for the maintenance of healing of erosive esophagitis in pediatric participants aged 1 to 17 years with endoscopically-confirmed, healed erosive esophagitis.

Connect with a study center

  • UZ Brussel

    Brussel, 1090
    Belgium

    Active - Recruiting

  • University clinical center of the Republic of Srpska

    Banja Luka, 78000
    Bosnia and Herzegovina

    Terminated

  • Evex clinic after I. Tsitsishvili

    Tbilisi, Georgia
    Georgia

    Active - Recruiting

  • Georgian-American Family Medicine Clinic

    Tbilisi, 0171
    Georgia

    Active - Recruiting

  • JSC Georgian Clinics

    Tbilisi, 0159
    Georgia

    Active - Recruiting

  • LTD Imedi Clinic

    Tbilisi, 0159
    Georgia

    Terminated

  • New Hospitals

    Tbilisi, 0114
    Georgia

    Active - Recruiting

  • Pediatric Clinic after G. Zhvania

    Tbilisi, 0159
    Georgia

    Active - Recruiting

  • Szegedi Tudományegyetem

    Szeged, Csongrád 6726
    Hungary

    Site Not Available

  • Heim Pal Pediatric Hospital

    Budapest, 1089
    Hungary

    Site Not Available

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032
    Hungary

    Site Not Available

  • Gujarat Hospital - Gastro & Vascular Centre

    Surat, Gujarat 395009
    India

    Site Not Available

  • Sanjeevani Children's Hospital

    Aurangabad, Maharashtra 431005
    India

    Site Not Available

  • SR Kalla Memorial Gastro & General Hospital

    Jaipur, Rajasthan 302001
    India

    Active - Recruiting

  • Yashoda Hospitals

    Secunderabad, Telangana 500003
    India

    Site Not Available

  • Medical college and Hospital

    Kolkata, WEST Bengal 700073
    India

    Site Not Available

  • Hospital HIMA San Pablo Caguas

    Caguas, 00725
    Puerto Rico

    Active - Recruiting

  • Chiara Biaggi de Casenave, MD

    Guaynabo, 00969
    Puerto Rico

    Active - Recruiting

  • Caribbean Clinical Research, LLC

    Ponce, 00716
    Puerto Rico

    Site Not Available

  • Puerto Rico Consortium for Clinical Investigation

    San Juan, 00936-3475
    Puerto Rico

    Active - Recruiting

  • University Children's Hospital

    Belgrade, 11000
    Serbia

    Active - Recruiting

  • University Clinical Center of Kragujevac

    Kragujevac, 34000
    Serbia

    Active - Recruiting

  • Detska fakultna nemocnica s poliklinikou Banska Bystrica

    Banska Bystrica, 974 09
    Slovakia

    Active - Recruiting

  • CLINIQ s.r.o.

    Bratislava, 811 09
    Slovakia

    Active - Recruiting

  • Narodny ustav detskych chorob

    Bratislava, 83340
    Slovakia

    Active - Recruiting

  • Univerzitna nemocnica Martin, Klinika deti a dorastu

    Martin, 036 59
    Slovakia

    Active - Recruiting

  • KM Management, spol. s r.o.,

    Nitra, 94901
    Slovakia

    Active - Recruiting

  • SBU Izmir Tepecik EAH

    Izmir, 35180
    Turkey

    Active - Recruiting

  • T.C. Saglik Bakanligi - Izmir Sehir Hastanesi

    Izmir, 35540
    Turkey

    Active - Recruiting

  • Queen Mary's Hospital for Children, Epsom and St Helier University Hospitals NHS Trust

    Carshalton, SM5 1AA
    United Kingdom

    Active - Recruiting

  • Evelina London Children's Hospital

    London, SE1 7EH
    United Kingdom

    Active - Recruiting

  • Great Ormond Street Hospital For Children NHS Foundation Trust

    London, WC1N 3JH
    United Kingdom

    Site Not Available

  • King's College Hospital NHS Foundation Trust

    London, SE5 9RS
    United Kingdom

    Active - Recruiting

  • Royal Free Hospital

    London, NW3 2QG
    United Kingdom

    Active - Recruiting

  • Childrens Hospital of Orange County

    Orange, California 92868
    United States

    Site Not Available

  • Baptist/Wolfson's Children's Hospital

    Jacksonville, Florida 32207
    United States

    Active - Recruiting

  • Nemours Children's Specialty Care

    Jacksonville, Florida 32207
    United States

    Active - Recruiting

  • Children's Healthcare of Atlanta - Center for Advanced Pediatrics

    Atlanta, Georgia 30329
    United States

    Active - Recruiting

  • Children's Healthcare of Atlanta-Egleston

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • The University of Chicago Medical Center

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • Methodist Medical Center of Illinois

    Peoria, Illinois 61636
    United States

    Active - Recruiting

  • Unity Point Health Pediatric Gastroenterology

    Peoria, Illinois 61602
    United States

    Active - Recruiting

  • Mayo Clinic Rochester

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • University of Rochester Medical Center

    Rochester, New York 14642
    United States

    Active - Recruiting

  • University of Rochester Medical Center Clinical Research Center

    Rochester, New York 14642
    United States

    Active - Recruiting

  • UPMC Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania 15224
    United States

    Active - Recruiting

  • Children's Health / Children's Medical Center

    Dallas, Texas 75235
    United States

    Active - Recruiting

  • Cabell Huntington Hospital Endoscopy Suite (Endoscopy Only)

    Huntington, West Virginia 25701
    United States

    Active - Recruiting

  • University Physicians and Surgeons, Inc dba Marshall Health

    Huntington, West Virginia 25701
    United States

    Active - Recruiting

  • UW Health E Terrace Dr Medical Center

    Madison, Wisconsin 53718
    United States

    Active - Recruiting

  • University Hospital and UW Health Clinics

    Madison, Wisconsin 53792
    United States

    Active - Recruiting

  • UW Health 2275 Deming Way Clinic

    Middleton, Wisconsin 53562
    United States

    Active - Recruiting

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