Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT00458614 · ClinicalTrials.gov registry record · Phase 1

Pharmacokinetic Study of Lansoprazole in Cystic Fibrosis

A Phase 1 study, sponsored by Arkansas Children's Hospital Research Institute.

Completed
Registry status
Phase 1
Development phase
18
Enrollment target

NCT00458614 is a Phase 1 study that has completed, run by Arkansas Children's Hospital Research Institute. The registered enrollment target is 18 participants.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT00458614, a Phase 1 study, has completed, sponsored by Arkansas Children's Hospital Research Institute.

COMPLETED
Registry status
Phase 1
Development phase
18 participants
Enrollment target

Study Summary

The disposition of a number of drugs has been reported to be altered in patients with Cystic Fibrosis (CF). Changes in pharmacokinetic parameters observed included increased volumes of distribution and increased clearance of renally eliminated drugs. The purpose of this this study is to characterize the pharmacokinetics of IV lansoprazole and its metabolites in normal healthy children and children with Cystic Fibrosis (CF) ages 2 to \< 10 years. It is suspected that children with CF will have a more rapid clearance as compared to healthy children.

Interventions

  • DRUG Lansoprazole

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2006-06
Est. Completion 2007-04
Phase Phase 1

What the Registry Record Tells You About NCT00458614

The ClinicalTrials.gov registry entry for NCT00458614 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Arkansas Children's Hospital Research Institute, which has 97 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Lansoprazole is the first listed.

NCT00458614 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00458614 about?

NCT00458614 is a clinical study titled "Pharmacokinetic Study of Lansoprazole in Cystic Fibrosis". The disposition of a number of drugs has been reported to be altered in patients with Cystic Fibrosis (CF). Changes in pharmacokinetic parameters observed included increased volumes of distribution and increased clearance of renally eliminated drugs. The purpose of this this study is to characterize...

What is the current status of trial NCT00458614?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2006-06. Estimated completion is 2007-04.

What interventions are being tested in trial NCT00458614?

The interventions under investigation include: Lansoprazole (DRUG).

Who is sponsoring clinical trial NCT00458614?

This trial is sponsored by Arkansas Children's Hospital Research Institute, which has 97 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.