drugset / Trial / NCT00209573
A Study of AQUAVAN® Injection Versus Midazolam HCl for Sedation in Patients Undergoing Elective Colonoscopy
Phase 3
Completed
270 enrolled
Eisai Inc.
Bio Analytical Research Corporation · collabCoghlan Group (Plasma Sample Supplies) · collabMDS Pharma Services · collabPPD Development, LP · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This study was designed to demonstrate that AQUAVAN® is effective in providing adequate sedation in patients undergoing colonoscopy as well as to assess the safety profile of AQUAVAN versus that of midazolam. Prior to the procedure, patients received fentanyl citrate for pain management followed five minutes later by AQUAVAN® Injection for sedation. Throughout the procedure, study personnel assessed the patient's vital signs and depth of sedation. After the procedure, the patient, physician, and an evaluator were asked to complete satisfaction surveys.
Timeline
- Start
- 2004-09
- Primary completion
- —
- Completion
- 2004-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | fospropofol | Small molecule | — | Intravenous |