drugset / Trial / NCT00209534
A Study of AQUAVAN® Injection in the Presence of Pre-Medication in Patients Undergoing Elective Colonoscopy
Phase 2
Completed
200 enrolled
Eisai Inc.
Bio Analytical Research Corporation · collabHHI Clinical Research (Biostatistics) · collabMDS Pharma Services · collabOmnicare Clinical Research · collabThe Coghlan Group (Plasma Sample Supplies) · collab
RandomizedFactorialOpen-labelTreatment
Summary
This study was designed to assess the safety and efficacy of AQUAVAN® Injection in providing adequate sedation in patients undergoing colonoscopy. 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
- 2003-01
- Primary completion
- —
- Completion
- 2004-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | fospropofol | Small molecule | — | — |