Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00209534
Status:
COMPLETED
Last Update Posted:
2009-12-04
First Post:
2005-09-13
Brief Title:
A Study of AQUAVAN Injection in the Presence of Pre-Medication in Patients Undergoing Elective Colonoscopy
Sponsor:
Eisai Inc
Organization:
Eisai Inc
Study Overview
Official Title:
A Phase 2 Two Part Study of AQUAVAN Injection in the Presence of Pre-Medication in Patients Undergoing Elective Colonoscopy
Status:
COMPLETED
Status Verified Date:
2009-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 patients vital signs and depth of sedation After the procedure the patient physician and an evaluator were asked to complete satisfaction surveys
Detailed Description:
Randomized open label multi-center adaptive dose ranging study in which several dose levels of AQUAVAN Injection and fentanyl citrate injection will be investigated to produce a desired sedation level in patients undergoing elective colonoscopy A desired sedative dosedose range and dosing paradigm will be identified based on pre-set criteria using the Modified Observers Assessment of AlertnessSedation OAAS The desired sedative dosedose range and dosing paradigm of AQUAVAN Injection is defined as one that consistently provides mild to moderate sedation Modified OAAS between 2 and 4 inclusive in a majority of patients who are pre-medicated with fentanyl citrate injection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None