NCT02401035

PREA, PK And Safety PASS Study Of IV Pantoprazole In Pediatric Subjects

AN OPEN-LABEL, MULTICENTER STUDY TO EVALUATE THE PHARMACOKINETICS OF SINGLE AND MULTIPLE INTRAVENOUS DOSES OF PANTOPRAZOLE IN TWO AGE COHORTS OF HOSPITALIZED PEDIATRIC SUBJECTS 1 TO 16 YEARS OF AGE WHO ARE CANDIDATES FOR ACID SUPPRESSION THERAPY

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 1 Year – 16 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to characterize the pharmacokinetics (PK) and safety of intravenous (IV) pantoprazole in patients 1 to 16 years old who are candidates for acid suppression therapy.

Detailed description

In hospitalized pediatric subjects, age 1 to 16 years who in the judgment of the investigator are candidates for acid suppression therapy, the following are the objectives of this trial: Primary Objectives To characterize the PK of single and multiple IV doses of pantoprazole in pediatric subjects aged 1 to less than 2 years old. To characterize the PK of single and multiple IV doses of pantoprazole in pediatric subjects aged 2 to 16 years old. Secondary Objectives To determine the safety, tolerability, and PK of single and multiple IV doses of pantoprazole in each of the independent age cohorts. To assess the CYP2C19 genotype in pediatric subjects receiving IV pantoprazole, to determine the presence of the gene for the major enzyme responsible for metabolism of pantoprazole.

Conditions

• Gastroesophageal Reflux Disease

Interventions

Type	Name	Description
DRUG	IV pantoprazole	Patients will receive 10 mg, 20 mg, or 40 mg IV pantoprazole determined by weight

Timeline

• Start date: 2017-05-09
• Primary completion: 2021-06-18
• Completion: 2021-06-18
• First posted: 2015-03-27
• Last updated: 2024-04-09
• Results posted: 2024-04-09

Locations

19 sites across 9 countries: United States, Argentina, Bosnia and Herzegovina, Georgia, Germany, Italy, Serbia, Slovakia, Ukraine

Regulatory

• FDA-regulated drug study