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Proton Pump Inhibitor

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

Phase 4
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0.25, 1 to 2, 3 to 4, and 5 to 6 hours post-dose on day 1; 0.25, 0.5, 1 to 2, 3 to 4, and 5 to 6, 8, and 12 hours post-dose on day 2; 0.25, 0.5, 1, 2, 4, 8, and 12 hours post-dose on day 7
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial studies how pantoprazole, given directly into the bloodstream, works in children aged 1 to 16 who need to reduce stomach acid. The goal is to understand how the drug moves through their bodies and how safe it is. Pantoprazole helps by stopping the production of stomach acid. Pantoprazole has been used for many years and is approved in over 100 countries.

Eligible Conditions
  • Acid Reflux

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0.25, 0.5, 1 to 2, 3 to 4, and 5 to 6, 8, and 12 hours post-dose on day 2; 0.25, 0.5, 1, 2, 4, 8, and 12 hours post dose on day 7
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0.25, 0.5, 1 to 2, 3 to 4, and 5 to 6, 8, and 12 hours post-dose on day 2; 0.25, 0.5, 1, 2, 4, 8, and 12 hours post dose on day 7 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Clearance (CL) of Pantoprazole
Volume of Distribution (Vd) of Pantoprazole
Secondary study objectives
Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Pantoprazole: Multiple Dose
Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Pantoprazole: Single Dose
Area Under the Plasma Concentration-time Profile From Time Zero to 24 Hour (AUC24) of Pantoprazole: Multiple Dose
+10 more

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: IV pantoprazoleExperimental Treatment1 Intervention
Patients will receive 10 mg, 20 mg, or 40 mg IV pantoprazole determined by weight.

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,675 Previous Clinical Trials
28,717,162 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,556 Previous Clinical Trials
25,758,018 Total Patients Enrolled
~2 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
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