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

Pfizer55 sites in 9 countries43 target enrollmentJanuary 13, 2022

ConditionsEsophagitis

InterventionsHalf Dose Pantoprazole plus matching placebo Full dose Pantoprazole plus matching placebo

DrugsFull dose Pantoprazole plus matching placebo Half Dose Pantoprazole plus matching placebo

Overview

Phase: Phase 2
Intervention: Half Dose Pantoprazole plus matching placebo
Conditions: Esophagitis
Sponsor: Pfizer
Enrollment: 43
Locations: 55
Primary Endpoint: 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
Status: Terminated
Last Updated: 19 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

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.

Registry

clinicaltrials.gov

Start Date

January 13, 2022

End Date

December 16, 2025

Last Updated

19 days ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

Arm 2 Half Dose Pantoprazole and matching placebo

Half Healing Dose of pantoprazole

Intervention: Half Dose Pantoprazole plus matching placebo

Arm 1 Full Dose Pantoprazole and matching placebo

Full Healing Dose of pantoprazole

Intervention: Full dose Pantoprazole plus matching placebo

Outcomes

Primary Outcomes

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

Time Frame: Week 24

Endoscopically confirmed maintenance of healing of erosive esophagitis at Week 24.

Secondary Outcomes

Number of Participants With Change From Baseline in Physical Examinations and Vital Signs(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(Baseline up to 36 weeks)