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NCT01260142 · ClinicalTrials.gov registry record · Phase 4
A PK/PD Study of Fospropofol Disodium Compared With Propofol Injectable Emulsion
A Phase 4 study, sponsored by Eisai.
- Completed
- Registry status
- Phase 4
- Development phase
- 36
- Enrollment target
NCT01260142: Completed Phase 4 study, sponsored by Eisai.
NCT01260142 is a Phase 4 study that has completed, run by Eisai. The registered enrollment target is 36 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01260142, a Phase 4 study, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 36 participants
- Enrollment target
Study Summary
This study is designed to characterize the pharmacokinetic and pharmacodynamic effect of fospropofol disodium in comparison to propofol. In addition, the study will compare the maximum sedative effect, safety and tolerability of fospropofol disodium and propofol.
Primary Outcome
AUC(0-inf) is a measure of drug concentration equal to the area under the plasma concentration-time profile from time 0 to infinity. An arterial line (A-line) and venous line (V-line) were placed prior to dosing during each treatment period and used to collect blood samples for plasma concentration measurements at specific time points. Plasma arterial and venous concentrations of fospropofol were quantified by high-performance liquid chromatography with mass spectrometric detection (LC-MS/MS). T
Interventions
- DRUG Fospropofol disodium, propofol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2010-11 |
| Est. Completion | 2011-03 |
| Phase | Phase 4 |
What the finished NCT01260142 record still lists
NCT01260142 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which Fospropofol disodium, propofol is the first listed.
NCT01260142 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01260142 about?
NCT01260142 is a clinical study titled "A PK/PD Study of Fospropofol Disodium Compared With Propofol Injectable Emulsion". This study is designed to characterize the pharmacokinetic and pharmacodynamic effect of fospropofol disodium in comparison to propofol. In addition, the study will compare the maximum sedative effect, safety and tolerability of fospropofol disodium and propofol.
What is the current status of trial NCT01260142?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 36 participants. The study started on 2010-11. Estimated completion is 2011-03.
What interventions are being tested in trial NCT01260142?
The interventions under investigation include: Fospropofol disodium, propofol (DRUG).
Who is sponsoring clinical trial NCT01260142?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01260142's enrollment target sits among peer trials
36 1490th of 2000 higher than 495 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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