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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

Study Summary

This trial will help researchers understand how well the drug works in children and teens, and how safe it is.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clearance (CL) of Pantoprazole
Volume of Distribution (Vd) of Pantoprazole
Secondary outcome measures
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
4,567 Previous Clinical Trials
10,911,855 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,474 Previous Clinical Trials
8,093,023 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment in this medical trial open at the present time?

"According to clinicaltrials.gov, this study is presently seeking participants which it first posted on May 9th 2017 and most recently updated November 8th 2022."

Answered by AI

To what extent does this experiment have capacity for participants?

"Affirmative. The information hosted on clinicaltrials.gov reveals this medical research is currently searching for participants, with the initial posting occurring 9th May 2017 and the latest update taking place 8th November 2022. 24 individuals are needed to be recruited between two distinct sites."

Answered by AI

Is there an age restriction on participation in this experiment?

"Patients that meet the requirements for participating in this medical trial must be between 1 year and 16 years old. In contrast, there are 19 trials available to those younger than 18 while 70 are catered towards elderly patients over 65."

Answered by AI

What prerequisites must participants fulfill to be accepted into this trial?

"24 individuals may be eligible to partake in this research study, provided they have been diagnosed with gastroesophageal reflux disease and are aged between one year old and sixteen years of age."

Answered by AI

What disorders have been alleviated by intravenous pantoprazole?

"Intravenous pantoprazole is an ideal solution for treating erosive esophagitis. It can also be beneficial in managing gastroesophageal reflux disorder, when patients are unable to take delayed-release tablets of pantoprazole, and situations where reducing gastric acid output is advised."

Answered by AI

What tangible goals is this medical study attempting to accomplish?

"The primary aim of this trial, which has a duration of two days, is to measure the volume distribution of IV pantoprazole. Quantitative descriptors will be used to analyse secondary outcomes such as maximum plasma concentration and area under the 0-24 hour time profile."

Answered by AI

Is there any potential harm associated with intravenous pantoprazole?

"The safety of IV pantoprazole is rated 3, as it has achieved Phase 4 status - a benchmark indicating its approval by the relevant medical authorities."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
PREA, PK And Safety PASS Study Of IV Pantoprazole In Pediatric Subjects
2017. "PREA, PK And Safety PASS Study Of IV Pantoprazole In Pediatric Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02401035.
~2 spots leftby Apr 2025
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