drugset / Trial / NCT00209599
A Study of AQUAVAN® Injection Versus Midazolam HCl for Sedation in Elderly Patients Undergoing Elective Colonoscopy
Phase 2
Terminated
100 enrolled
Eisai Inc.
Covance · collabPPD Development, LP · collabQuest Pharmaceutical Services · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This study was designed to demonstrate that AQUAVAN® is effective in providing adequate sedation in elderly 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
- 2005-02
- Primary completion
- —
- Completion
- 2005-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | fospropofol | Small molecule | — | Intravenous |