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

NCT02401035 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2024-04-09

Study results available
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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.

Conditions

  • Gastroesophageal Reflux Disease

Interventions

DRUG

IV pantoprazole

Patients will receive 10 mg, 20 mg, or 40 mg IV pantoprazole determined by weight

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-09
Primary Completion
2021-06-18
Completion
2021-06-18
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Bosnia and Herzegovina
  • Georgia
  • Germany
  • Italy
  • Serbia
  • Slovakia
  • Ukraine

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02401035 on ClinicalTrials.gov