Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01887743 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics of Pantoprazole and CYP2C19 Activity in Children and Adolescents With GERD: A Pilot Study
A Phase 1 study, sponsored by Children's Mercy Hospital Kansas City.
- Completed
- Registry status
- Phase 1
- Development phase
- 71
- Enrollment target
NCT01887743 is a Phase 1 study that has completed, run by Children's Mercy Hospital Kansas City. The registered enrollment target is 71 participants.
The verdict
NCT01887743, a Phase 1 study, has completed, sponsored by Children's Mercy Hospital Kansas City.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 71 participants
- Enrollment target
Study Summary
The World Health Organization has declared childhood obesity to be "one of the most serious public health challenges of the 21st century," (http://www.who.int/dietphysicalactivity/childhood). Given that obese children are generally excluded from clinical trials, little to no information exists regarding the impact of obesity on drug disposition and drug action, creating a gap in physicians' knowledge on how to appropriately select the dose of many critical medications (e.g., anticancer agents), so as to prevent toxicity associated with overdosing, while avoiding the harms of under-treatment. The proposed study will examine the effect of obesity on the metabolism of a commonly used medication, the proton pump inhibitor pantoprazole, by exploring the relationships between age, obesity, basal metabolic rate and genetic control of the enzyme primarily responsible for pantoprazole metabolism. We will also validate a simple breath test that can be used to predict pantoprazole dose requirement for obese children. The study is designed to test the following experimental hypotheses:\[13C\]-pantoprazole pharmacokinetic parameters are not different between non-obese and obese children and adolescents, collectively (both age groups combined) or stratified by age group (SA 1) \[13C\]-pantoprazole pharmacokinetic parameters or DOB values (and thus, CYP2C19 activity) are not different between males and females (SA 1 \& 2) \[13C\]-pantoprazole pharmacokinetic parameters and DOB (Delta over baseline) values (and thus, CYP2C19 activity) are independent of age over the age range of 6 to 17 years (SA 1 \& 2) Obesity does not alter the relative contributions of CYP2C19-dependent and non-CYP2C19-dependent (i.e., CYP3A4) metabolism of pantoprazole, as measured by the urinary ratio of 4-hydroxy-pantoprazole to pantoprazole sulfone (SA 1 \& 2) The \[13C\]-pantoprazole breath test, by determining DOB at discrete time point(s), is a non-invasive measure of CYP2C19 phenotype (SA 2) Clearance
Interventions
- DRUG Pantoprazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2013-06 |
| Est. Completion | 2015-10 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01887743
The ClinicalTrials.gov registry entry for NCT01887743 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 71 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Mercy Hospital Kansas City, which has 184 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Pantoprazole is the first listed.
NCT01887743 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01887743 about?
NCT01887743 is a clinical study titled "Pharmacokinetics of Pantoprazole and CYP2C19 Activity in Children and Adolescents With GERD: A Pilot Study". The World Health Organization has declared childhood obesity to be "one of the most serious public health challenges of the 21st century," (http://www.who.int/dietphysicalactivity/childhood). Given that obese children are generally excluded from clinical trials, little to no information exists regar...
What is the current status of trial NCT01887743?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 71 participants. The study started on 2013-06. Estimated completion is 2015-10.
What interventions are being tested in trial NCT01887743?
The interventions under investigation include: Pantoprazole (DRUG).
Who is sponsoring clinical trial NCT01887743?
This trial is sponsored by Children's Mercy Hospital Kansas City, which has 184 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.