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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Esophagitis

Treatments: Drug: Half Dose Pantoprazole plus matching placebo; Drug: Full dose Pantoprazole plus matching placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04821310

2023-508770-28-00 (Registry Identifier)

B1791094

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 1 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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43 participants in 2 patient groups

Arm 1 Full Dose Pantoprazole and matching placebo

Active Comparator group

Description:

Full Healing Dose of pantoprazole

Treatment:

Drug: Full dose Pantoprazole plus matching placebo

Arm 2 Half Dose Pantoprazole and matching placebo

Active Comparator group

Description:

Half Healing Dose of pantoprazole

Treatment:

Drug: Half Dose Pantoprazole plus matching placebo