Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00261599 · ClinicalTrials.gov registry record · Phase 3
An Effectiveness and Safety Study of AQUAVAN® Injection (Fospropofol Disodium) for Sedation During Colonoscopy
A Phase 3 study of Conscious Sedation, sponsored by Eisai.
- Completed
- Registry status
- Phase 3
- Development phase
- 300
- Enrollment target
- 20
- Study locations
NCT00261599 is a Phase 3 study of Conscious Sedation that has completed, run by Eisai. The registered enrollment target is 300 participants. The trial reports 20 study locations across 15 states.
The verdict
NCT00261599, a Phase 3 study of Conscious Sedation, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 300 participants
- Enrollment target
- 20
- Study locations
Study Summary
Very often patients receive medication before a diagnostic procedure, like a colonoscopy, to help them relax and stay calm during the procedure. This is called procedural or minimal-to-moderate sedation. One product used for sedation is called propofol. AQUAVAN (fospropofol disodium) is made as a water soluble form of propofol allowing for rapid sedation during the entire procedure. This study is designed to test AQUAVAN for sedation during colonoscopy procedures.
Conditions Studied
Interventions
- DRUG AQUAVAN® (fospropofol disodium) Injection
- DRUG Midazolam HCI
Study Locations (20)
Maryland
- Chevy Chase Clinical Research - Chevy Chase
- Maryland Digestive Diseases Center - Laurel
- Shah Associates - Prince Frederick
Indiana
- Welborn Clinic - Evansville
- Indiana University Medical Center/Clarian Health Partner - Indianapolis
Michigan
- Oakland Colon & Rectal Associates - Royal Oak
- Center for Digestive Health - Troy
Tennessee
- Memphis Gastroenterology Group, PC - Germantown
- Gastrointestinal Institute - Nashville
Alabama
- Clinical Research Associates - Huntsville
California
- UCSF-Fresno/University Medical Center - Fresno
Florida
- Borland-Groover Clinic - Jacksonville
Illinois
- Rockford Gastroenterology Associates - Rockford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2006-03 |
| Est. Completion | 2006-10 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00261599
The ClinicalTrials.gov registry entry for NCT00261599 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 300 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 1 condition, with Conscious Sedation appearing as the primary indexed condition, and to 2 interventions - of which AQUAVAN® (fospropofol disodium) Injection is the first listed.
NCT00261599 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Maryland, Indiana, Michigan.
Frequently Asked Questions
What is clinical trial NCT00261599 about?
NCT00261599 is a clinical study titled "An Effectiveness and Safety Study of AQUAVAN® Injection (Fospropofol Disodium) for Sedation During Colonoscopy". Very often patients receive medication before a diagnostic procedure, like a colonoscopy, to help them relax and stay calm during the procedure. This is called procedural or minimal-to-moderate sedation. One product used for sedation is called propofol. AQUAVAN (fospropofol disodium) is made as a wa...
What is the current status of trial NCT00261599?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 300 participants. The study started on 2006-03. Estimated completion is 2006-10.
What conditions does trial NCT00261599 study?
This clinical trial studies the following conditions: Conscious Sedation.
What interventions are being tested in trial NCT00261599?
The interventions under investigation include: AQUAVAN® (fospropofol disodium) Injection (DRUG), Midazolam HCI (DRUG).
Who is sponsoring clinical trial NCT00261599?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00261599 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Conscious Sedation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.