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

AN EXPLORATORY, MULTICENTER, RANDOMIZED, DOUBLE BLIND STUDY OF CLINICAL OUTCOMES, TOLERABILITY, AND SAFETY OF 2 DOSES OF ORAL PANTOPRAZOLE IN PEDIATRIC PARTICIPANTS AGED 1 TO 11 YEARS AND 12 TO 17 YEARS WHO REQUIRE MAINTENANCE THERAPY FOR HEALED EROSIVE ESOPHAGITIS

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.

Study Overview

• Status: Recruiting
• Conditions: Esophagitis
• Intervention / Treatment: Drug: Full dose Pantoprazole plus matching placebo; Drug: Half Dose Pantoprazole plus matching placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• Belgium
  • Brussel, Belgium, 1090
    • Recruiting
    • UZ Brussel
• Bosnia and Herzegovina
  • Banja Luka, Bosnia and Herzegovina, 78000
    • Recruiting
    • University Clinical Center of the Republic of Srpska
• Georgia
  • Tbilisi, Georgia, 0114
    • Recruiting
    • New Hospitals
  • Tbilisi, Georgia, 0159
    • Recruiting
    • LTD Imedi Clinic
  • Tbilisi, Georgia, 0171
    • Recruiting
    • Georgian-American Family Medicine Clinic
  • Tbilisi, Georgia, Georgia
    • Recruiting
    • Evex clinic after I. Tsitsishvili
  • Tbilisi, Georgia, 0159
    • Recruiting
    • Pediatric Clinic after G. Zhvania
• Hungary
  • Budapest, Hungary, 1089
    • Not yet recruiting
    • Heim Pal Pediatric Hospital
  • Debrecen, Hungary, 4032
    • Not yet recruiting
    • Debreceni Egyetem Klinikai Kozpont
  • Csongrád
    • Szeged, Csongrád, Hungary, 6726
      • Not yet recruiting
      • Szegedi Tudomanyegyetem
• India
  • Gujarat
    • Surat, Gujarat, India, 395009
      • Not yet recruiting
      • Gujarat Hospital - Gastro & Vascular Centre
  • Maharashtra
    • Aurangabad, Maharashtra, India, 431005
      • Not yet recruiting
      • Sanjeevani Children's Hospital
  • Rajasthan
    • Jaipur, Rajasthan, India, 302001
      • Not yet recruiting
      • SR Kalla Memorial Gastro & General Hospital
  • Telangana
    • Secunderabad, Telangana, India, 500003
      • Not yet recruiting
      • Yashoda Hospitals
• Puerto Rico
  • Caguas, Puerto Rico, 00725
    • Recruiting
    • Hospital HIMA San Pablo Caguas
  • Guaynabo, Puerto Rico, 00969
    • Recruiting
    • Chiara Biaggi de Casenave, MD
• Serbia
  • Belgrade, Serbia, 11000
    • Recruiting
    • University Children's Hospital
  • Kragujevac, Serbia, 34000
    • Recruiting
    • University Clinical Center of Kragujevac
• Slovakia
  • Banska Bystrica, Slovakia, 974 09
    • Recruiting
    • Detska fakultna nemocnica s poliklinikou Banska Bystrica
  • Bratislava, Slovakia, 83340
    • Recruiting
    • Narodny ustav detskych chorob
  • Martin, Slovakia, 036 59
    • Recruiting
    • Univerzitna nemocnica Martin, Klinika deti a dorastu
  • Nitra, Slovakia, 94901
    • Recruiting
    • KM Management, spol. s r.o.,
• Turkey
  • Izmir, Turkey, 35180
    • Recruiting
    • SBU Izmir Tepecik EAH
• United Kingdom
  • Carshalton, United Kingdom, SM5 1AA
    • Recruiting
    • Queen Mary's Hospital for Children, Epsom and St Helier University Hospitals NHS Trust
  • London, United Kingdom, SE5 9RS
    • Recruiting
    • King's College Hospital NHS Foundation Trust
  • London, United Kingdom, SE1 7EH
    • Recruiting
    • Evelina London Children's Hospital
  • London, United Kingdom, NW3 2QG
    • Recruiting
    • Royal Free Hospital
  • London, United Kingdom, WC1N 3JH
    • Recruiting
    • Great Ormond Street Hospital For Children NHS Foundation Trust
  • London, United Kingdom, WC1N 3JH
    • Not yet recruiting
    • Great Ormond Street Hospital For Children NHS Foundation Trust
• United States
  • California
    • Orange, California, United States, 92868
      • Not yet recruiting
      • Childrens Hospital of Orange County
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Recruiting
      • Nemours Children's Specialty Care
    • Jacksonville, Florida, United States, 32207
      • Recruiting
      • Baptist/Wolfson's Children's Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Children's Healthcare of Atlanta-Egleston
    • Atlanta, Georgia, United States, 30329
      • Recruiting
      • Children's Healthcare of Atlanta - Center for Advanced Pediatrics
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • The University of Chicago Medical Center
    • Peoria, Illinois, United States, 61636
      • Recruiting
      • Methodist Medical Center of Illinois
    • Peoria, Illinois, United States, 61603
      • Recruiting
      • Methodist Medical Center of Illinois
    • Peoria, Illinois, United States, 61602
      • Recruiting
      • Unity Point Health Pediatric Gastroenterology
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic Rochester
  • New York
    • Rochester, New York, United States, 14642
      • Recruiting
      • University of Rochester Medical Center
    • Rochester, New York, United States, 14642
      • Recruiting
      • University of Rochester Medical Center Clinical Research Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • Recruiting
      • UPMC Children's Hospital of Pittsburgh
  • Texas
    • Dallas, Texas, United States, 75235
      • Recruiting
      • Children's Health / Children's Medical Center
  • West Virginia
    • Huntington, West Virginia, United States, 25701
      • Recruiting
      • Cabell Huntington Hospital Endoscopy Suite (Endoscopy Only)
    • Huntington, West Virginia, United States, 25701
      • Recruiting
      • University Physicians and Surgeons, Inc dba Marshall Health
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Recruiting
      • University Hospital and UW Health Clinics
    • Madison, Wisconsin, United States, 53718
      • Recruiting
      • UW Health E Terrace Dr Medical Center
    • Middleton, Wisconsin, United States, 53562
      • Recruiting
      • UW Health 2275 Deming Way Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants must have a documented erosive lesion with an Los Angeles (LA) Grade of A 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 the eDiary
• Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures, including the use of the eDiary.
• Male and female participants aged 1 to 17 years.
• Minimum body weight 7 kilogram and weight at least at the 5th percentile per the Center 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 meet at least 1 of the following criteria :
• Premenarchal: The investigator (or other appropriate staff) must discuss the participant's premenarchal status with the participant and parent/legal guardian at office visits and during telephone contacts, as participants who achieve menarche during the study would no longer be considered "female participants of non childbearing potential" and must comply with the protocol requirements applicable to women of childbearing potential.

Exclusion Criteria:

• Previous administration of an investigational drug or vaccine within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).
• Children that may be at high risk from procedural sedation should be carefully evaluated. Participants with a history of complications during prior procedural sedation
• 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 to any substituted benzimidazole or to any of the excipients.
• Any disorder requiring chronic (daily) use of warfarin, heparin, other anticoagulants, methotrexate, atazanavir or nelfinavir, clopidogrel, or potent inhibitors 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 acquired immune deficiency syndrome.
• Active malignancy of any type, or history of a malignancy. Participants with a history of malignancies that have been surgically removed or eradicated by irradiation or chemotherapy and who have no evidence of recurrence for at least 5 years before Screening are acceptable.
• Diagnosed as having or has received treatment for esophageal, gastric, pyloric channel, or duodenal ulceration within 30 days before the Screening visit.
• Alanine aminotransferase or blood urea nitrogen >2.0 upper limit of normal or estimated creatinine >1.5 X upper limit of normal for age or any other laboratory abnormality considered by the Investigator to be clinically significant within 14 days before the Baseline Visit (Day 1).
• Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or study intervention administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into 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 with the 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1 Full Dose Pantoprazole and matching placebo; Full Healing Dose of pantoprazole	Drug: Full dose Pantoprazole plus matching placebo; Full healing dose of pantoprazole plus matching placebo
Active Comparator: Arm 2 Half Dose Pantoprazole and matching placebo; Half Healing Dose of pantoprazole	Drug: Half Dose Pantoprazole plus matching placebo; Half healing dose of pantoprazole plus matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with endoscopically confirmed maintenance of healing of erosive esophagitis at Week 24, considering patients with excessive use of rescue medication as treatment failures	Endoscopically confirmed maintenance of healing of erosive esophagitis at Week 24.	Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Change From Baseline in Physical Examinations and Vital Signs	Safety and tolerability will be assessed by physical examinations, blood pressure, and pulse rate.	Baseline up to 36 weeks
Incidence of Adverse Events (AEs)		Baseline up to 36 weeks
Number of Participants With Change From Baseline in Laboratory Tests Results	Safety and tolerability will be assessed by clinical laboratory measurements	Baseline up to 36 weeks

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2022
• Primary Completion (Estimated): December 9, 2027
• Study Completion (Estimated): December 9, 2027

Study Registration Dates

• First Submitted: March 26, 2021
• First Submitted That Met QC Criteria: March 26, 2021
• First Posted (Actual): March 29, 2021

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: esophagitis; Erosive
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Esophageal Diseases; Esophagitis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Pantoprazole
• Other Study ID Numbers: B1791094; 2020-005030-15 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No