COMPLETED

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-01-13

Study Completion:2025-12-16

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT04821310

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Year to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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.	* 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). * 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

Inclusion Criteria

Exclusion 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.

* 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).
* 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

Contacts and Locations

Principal Investigator

Pfizer CT.gov Call Center

STUDY_DIRECTOR

Pfizer

Study Locations (Sites)

Baptist/Wolfson's Children's Hospital

Jacksonville, Florida, 32207

United States

Nemours Children's Health, Jacksonville

Jacksonville, Florida, 32207

United States

University of Rochester

Rochester, New York, 14627

United States

University of Rochester Medical Center Clinical Research Center

Rochester, New York, 14642

United States

Board of Regents of the University of Wisconsin System

Madison, Wisconsin, 53715

United States

UW Health E Terrace Dr Medical Center

Madison, Wisconsin, 53718

United States

University Hospital and UW Health Clinics

Madison, Wisconsin, 53792

United States

UW Health 2275 Deming Way Clinic

Middleton, Wisconsin, 53562

United States

Collaborators and Investigators

Sponsor: Pfizer

Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-13

Study Completion Date2025-12-16

Study Record Updates

Study Start Date2022-01-13

Study Completion Date2025-12-16

Terms related to this study

Keywords Provided by Researchers

Erosive
esophagitis

Additional Relevant MeSH Terms

Esophagitis