A Double-blind, Randomized, Multicenter, 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

NCT01127438 Phase 4 COMPLETED Results posted

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.

Details

Lead sponsor	Eisai Inc.
Phase	Phase 4
Status	COMPLETED
Enrolment	153
Start date	2010-04
Completion	2011-06

Conditions

• Sedation

Interventions

• fospropofol disodium Subgroup 1 Lower Dose
• fospropofol disodium Subgroup 1 Approved Dose
• fospropofol disodium Subgroup 2 Lower Dose
• fospropofol disodium Subgroup 2 Approved Dose
• fospropofol disodium Subgroup 3 Lower Dose
• fospropofol disodium Subgroup 3 Approved Dose

Primary outcomes

• Number of Participants With Sedation Success — Day 1
  Sedation success was defined as subjects who met the following 4 criteria: had 3 consecutive Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scores at or less than 4 after administration of sedative medication, completed the procedure, did not require the use of alternative sedative medication, and did not require manual/mechanical ventilation. The MOAA/S score was used to clinically rate the level of sedation using a score of 0 to 5 based on the subject's level of responsiveness. A high score on the MOAA/S scale indicated a lower level of sedation.

Countries

United States