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: Completed Phase 3 study of Conscious Sedation, sponsored by Eisai.
NCT00261599 is a Phase 3 study of Conscious Sedation that has completed, run by Eisai. The registered enrollment target is 300 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00261599 record still lists
NCT00261599 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower).
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 names 20 study sites across 15 states, led by 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.
Where NCT00261599's enrollment target sits among peer trials
300 1122nd of 2000 higher than 840 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
- NCT00353483 · 300 participants
Effect of Neoadjuvant or Adjuvant Systemic Therapy on Breast Cancers, Bone Marrow Cancer Cells, and Circulating Cancer Cells
- NCT00588185 · 300 participants · NA
[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone Pet Imaging in Patients With Progressive Prostate Cancer
- NCT00682032 · 300 participants · NA
The Effect of Beta-glucan in Non-Small Cell Lung Cancer
- NCT00870064 · 300 participants · NA
The Treatment of Type I Open Fractures in Pediatrics
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