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: Completed Phase 1 study, sponsored by Arkansas Children's Hospital Research Institute.
NCT00458614 is a Phase 1 study that has completed, run by Arkansas Children's Hospital Research Institute. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00458614 record still lists
NCT00458614 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 1 intervention - of which Lansoprazole is the first listed.
NCT00458614 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00458614's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01245179 · 18 participants · Phase 1
Study of Panobinostat (LBH589) in Patients With Sickle Cell Disease
- NCT01999361 · 18 participants · NA
Prevention of de Novo Allosensitization in Islet Transplant Recipients Following Complete Graft Loss
- NCT02359825 · 18 participants · Phase 1
Nerve Repair Using Hydrophilic Polymers to Promote Immediate Fusion of Severed Axons and Swift Return of Function
- NCT02870244 · 18 participants · Phase 1
Adoptive T Cell Immunotherapy for Advanced Melanoma Using Engineered Lymphocytes
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia