Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00209573
Status:
COMPLETED
Last Update Posted:
2008-11-07
First Post:
2005-09-13
Brief Title:
A Study of AQUAVAN Injection Versus Midazolam HCl for Sedation in Patients Undergoing Elective Colonoscopy
Sponsor:
Eisai Inc
Organization:
Eisai Inc
Study Overview
Official Title:
A Phase III Randomized Open-Label Study to Assess the Safety and Efficacy of AQUAVAN Injection Versus Midazolam HCl for Sedation in Patients Undergoing Colonoscopy Procedures
Status:
COMPLETED
Status Verified Date:
2008-11
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 demonstrate that AQUAVAN is effective in providing adequate sedation in 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 patients vital signs and depth of sedation After the procedure the patient physician and an evaluator were asked to complete satisfaction surveys
Detailed Description:
This is a randomized open-label study designed to assess the safety and efficacy of AQUAVAN Injection versus midazolam HCl following pretreatment with an analgesic fentanyl citrate injection in producing sedation in patients undergoing colonoscopy Randomization will be stratified by site Following completion of pre-procedure sedation assessments patients will be randomly assigned to 1 of the 2 iv treatment groups at a 31 AQUAVAN Injection midazolam HCl allocation ratio All study patients irrespective of treatment group assignment will receive fentanyl citrate injection as an analgesic pretreatment Supplemental doses of fentanyl citrate injection may be administered if the patient reports pain or if inadequate analgesia is present as demonstrated by increased heart rate andor blood pressure in the presence of adequate sedation At no time should fentanyl citrate injection be administered to increase sedation levels AQUAVAN Injection and midazolam HCl will be administered to induce a state of adequate sedation defined as a Modified Observers Assessment of Alertness Sedation OAAS score of 4 or less Supplemental doses will be administered to increase depth or duration of sedation Supplemental doses will not be administered if the Modified OAAS score is 2 or less or if there is no purposeful response to stimulation The depth of sedation will be measured by the Modified OAAS scale a validated measure Patient and Investigator assessments will be used to confirm the depth of sedation provided met the goals of sedation reduction of anxiet and reduced awareness
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