drugset / Trial / NCT01127438
A Dose-ranging Study to Evaluate the Safety and Efficacy of LUSEDRA (Fospropofol Disodium) as an Intravenous Sedative for Diagnostic or Therapeutic Colonoscopy in Adult Special Populations
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of this study is to evaluate the safety and efficacy of LUSEDRA (fospropofol disodium) and to determine whether a dose lower than currently approved can provide effective moderate sedation required to complete diagnostic or therapeutic procedures.
Timeline
- Start
- 2010-04
- Primary completion
- 2011-06
- Completion
- 2011-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | fospropofol | Small molecule | 3.9 mg/kg | Intravenous |
| Comparator | fospropofol | Small molecule | 4.875 mg/kg | Intravenous |
| Comparator | fospropofol | Small molecule | 6.5 mg/kg | Intravenous |
| Comparator | fospropofol | Small molecule | 297.5 mg | Intravenous |
| Comparator | fospropofol | Small molecule | 385 mg | Intravenous |
Indications
No indication recorded.