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Proton Pump Inhibitor

IV pantoprazole for Acid Reflux

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

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

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
4,635 Previous Clinical Trials
17,736,666 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,525 Previous Clinical Trials
14,909,229 Total Patients Enrolled
~2 spots leftby Oct 2025
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