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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2006-06 |
| Est. Completion | 2007-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗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.
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