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NCT00668902 · ClinicalTrials.gov registry record · NA

Rapid Screening Phenotype Test To Evaluate CYP 2C19 Enzyme Activity Using Stable Isotope [13C]Pantoprazole

A NA study, sponsored by Indiana University.

Completed
Registry status
NA
Development phase
25
Enrollment target

NCT00668902: Completed NA study, sponsored by Indiana University.

NCT00668902 is a NA study that has completed, run by Indiana University. The registered enrollment target is 25 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00668902, a NA study, has completed, sponsored by Indiana University.

COMPLETED
Registry status
NA
Development phase
25 participants
Enrollment target

Study Summary

The purpose of this study is to determine the function of an enzyme that breaks down drugs and helps the removal of drugs from your body. This enzyme is called cytochrome P450 2C19 and is located in your liver. Exposure to other medications or variations in genes that you have inherited from your parents, may speed up or slow the function of this enzyme. As a result, some patients may develop unwanted effects from a drug while some other patients may not get benefit from taking the same drug. The aim of this study is to determine the function of this enzyme in your liver. We will do this by performing a series of breath tests and blood samples after you take pantoprazole. Pantoprazole is approved as an oral and intravenous drug by the Food and Drug Administration (FDA).

Primary Outcome

The stable isotope \[13C\]pantoprazole is O-demethylated by cytochrome P450 CYP2C19 and that the 13CO2 produced and exhaled in breath as a result can serve as a safe, rapid, and noninvasive phenotyping marker of CYP2C19 activity in vivo. Exhaled 13CO2 and 12CO2 were measured by IR spectroscopy before (baseline) and 2.5 to 120 min after dosing. Ratios of 13CO2/12CO2 after \[13C\]pantoprazole relative to 13CO2/12CO2 at baseline were expressed as change over baseline (DOB).

Interventions

  • DRUG [13C]Pantoprazole

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2007-03
Est. Completion 2009-01
Phase NA
Indiana University

890 total trials

What the finished NCT00668902 record still lists

NCT00668902 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 1 intervention - of which [13C]Pantoprazole is the first listed.

NCT00668902 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00668902 about?

NCT00668902 is a clinical study titled "Rapid Screening Phenotype Test To Evaluate CYP 2C19 Enzyme Activity Using Stable Isotope [13C]Pantoprazole". The purpose of this study is to determine the function of an enzyme that breaks down drugs and helps the removal of drugs from your body. This enzyme is called cytochrome P450 2C19 and is located in your liver. Exposure to other medications or variations in genes that you have inherited from your pa...

What is the current status of trial NCT00668902?

This trial is currently completed. It is a NA study. The enrollment target is 25 participants. The study started on 2007-03. Estimated completion is 2009-01.

What interventions are being tested in trial NCT00668902?

The interventions under investigation include: [13C]Pantoprazole (DRUG).

Who is sponsoring clinical trial NCT00668902?

This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00668902's enrollment target sits among peer trials

25 1712th of 2000 higher than 265 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00668902, the US trial registry maintained by the National Library of Medicine. NCT00668902 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.