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

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.

Conditions

Esophagitis

Study Overview

Study Details

Study overview

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.

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

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

Condition
Esophagitis
Intervention / Treatment

-

Contacts and Locations

Orange

Childrens Hospital of Orange County, Orange, California, United States, 92868

Jacksonville

Baptist/Wolfson's Children's Hospital, Jacksonville, Florida, United States, 32207

Jacksonville

Nemours Children's Specialty Care, Jacksonville, Florida, United States, 32207

Atlanta

Children's Healthcare of Atlanta-Egleston, Atlanta, Georgia, United States, 30322

Atlanta

Children's Healthcare of Atlanta - Center for Advanced Pediatrics, Atlanta, Georgia, United States, 30329

Chicago

The University of Chicago Medical Center, Chicago, Illinois, United States, 60637

Peoria

Unity Point Health Pediatric Gastroenterology, Peoria, Illinois, United States, 61602

Peoria

Methodist Medical Center of Illinois, Peoria, Illinois, United States, 61603

Peoria

Methodist Medical Center of Illinois, Peoria, Illinois, United States, 61636

Rochester

Mayo Clinic Rochester, Rochester, Minnesota, United States, 55905

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

1 Year to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Pfizer,

Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

2027-12-09