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NCT00125424 · ClinicalTrials.gov registry record · Phase 2
Study of AQUAVAN® Injection (AQUAVAN; Fospropofol Disodium) for Sedation During Colonoscopy
A Phase 2 study, sponsored by Eisai.
- Completed
- Registry status
- Phase 2
- Development phase
- 125
- Enrollment target
NCT00125424 is a Phase 2 study that has completed, run by Eisai. The registered enrollment target is 125 participants.
The verdict
NCT00125424, a Phase 2 study, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 125 participants
- Enrollment target
Study Summary
Very often, patients receive sedative medication before a diagnostic, therapeutic, or surgical procedure to help them relax, keep them calm, and to relieve them from pain. This is called procedural sedation. During procedural (mild to moderate) sedation, a patient is first given a pain-relief medication (analgesic) and then a medication to help him/her relax and keep him/her calm (sedative). Propofol is the drug commonly used for sedation because it releases immediately into the blood stream and causes fast sedation. AQUAVAN (fospropofol disodium) is made as a slow release version of propofol, allowing for fast sedation and possibly faster recovery and discharge. This study is intended to compare several different doses of AQUAVAN in patients having a colonoscopy in order to find the right dose that will get patients to a level of mild to moderate (procedural) sedation.
Interventions
- DRUG AQUAVAN® (fospropofol disodium) Injection
- DRUG Midazolam HCl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2005-07 |
| Est. Completion | 2005-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00125424
The ClinicalTrials.gov registry entry for NCT00125424 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 125 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 2 interventions - of which AQUAVAN® (fospropofol disodium) Injection is the first listed.
NCT00125424 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00125424 about?
NCT00125424 is a clinical study titled "Study of AQUAVAN® Injection (AQUAVAN; Fospropofol Disodium) for Sedation During Colonoscopy". Very often, patients receive sedative medication before a diagnostic, therapeutic, or surgical procedure to help them relax, keep them calm, and to relieve them from pain. This is called procedural sedation. During procedural (mild to moderate) sedation, a patient is first given a pain-relief medica...
What is the current status of trial NCT00125424?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 125 participants. The study started on 2005-07. Estimated completion is 2005-09.
What interventions are being tested in trial NCT00125424?
The interventions under investigation include: AQUAVAN® (fospropofol disodium) Injection (DRUG), Midazolam HCl (DRUG).
Who is sponsoring clinical trial NCT00125424?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
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