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NCT00125398 · ClinicalTrials.gov registry record · Phase 2
GPI 15715 For Sedation in the Intensive Care Unit (ICU) Setting
A Phase 2 study, sponsored by Eisai.
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT00125398 is a Phase 2 study that has completed, run by Eisai. The registered enrollment target is 60 participants.
The verdict
NCT00125398, a Phase 2 study, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
Study Summary
Patients who are in the intensive care unit after surgery and require mechanical breathing support (intubation and ventilation) usually require sedation to avoid agitation and excessive stress responses. Short-acting sedatives such as midazolam and propofol are the drugs typically used for this. Propofol provides for fast sedation and fast recovery from sedation. Midazolam is slower to sedation and slower for recovery, but may provide some advantages over propofol, such as a lower incidence of hypotension (low blood pressure). This study will look at propofol compared to a product with fast sedation and recovery like that of propofol but with less of a chance for hypotension like with midazolam. Patients will be treated with the product for up to 8 hours and then will be monitored for 8 hours following treatment.
Interventions
- DRUG AQUAVAN (fospropofol disodium; GPI 15715 )
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2005-07 |
| Est. Completion | 2007-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00125398
The ClinicalTrials.gov registry entry for NCT00125398 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eisai, which has 287 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which AQUAVAN (fospropofol disodium; GPI 15715 ) is the first listed.
NCT00125398 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00125398 about?
NCT00125398 is a clinical study titled "GPI 15715 For Sedation in the Intensive Care Unit (ICU) Setting". Patients who are in the intensive care unit after surgery and require mechanical breathing support (intubation and ventilation) usually require sedation to avoid agitation and excessive stress responses. Short-acting sedatives such as midazolam and propofol are the drugs typically used for this. Pro...
What is the current status of trial NCT00125398?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2005-07. Estimated completion is 2007-05.
What interventions are being tested in trial NCT00125398?
The interventions under investigation include: AQUAVAN (fospropofol disodium; GPI 15715 ) (DRUG).
Who is sponsoring clinical trial NCT00125398?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
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