Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00209560
Status:
TERMINATED
Last Update Posted:
2015-01-09
First Post:
2005-09-13
Brief Title:
A Study of AQUAVAN Injection in the Presence of Pre-Medication in Patients Undergoing Minor Surgical Procedures
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 Minor Surgical Procedures
Status:
TERMINATED
Status Verified Date:
2014-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the safety tolerability and efficacy of AQUAVAN Injection when used for mild-to-moderate sedation in patients undergoing minor surgical procedures
Detailed Description:
Randomized open label multi-centermidazolam 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 minor surgical andor therapeutic procedures 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 majority of patients who are pre-medicated with fentanyl citrate injection
Midazolam is the most widely used iv agent for minimal-to-moderate sedation The dose range of midazolam to induce minimal to moderate sedation was based on standard clinical practice
new paragraph All patients were pre-medicated with fentanyl citrate as an analgesic
The outpatient setting has become increasingly popular for various types of medical procedures requiring sedation In outpatient minor surgical procedures sedation agents are used to provide mild-to-moderate sedation and are used with other medicines for pain management Surgeons have searched for alternative treatments to use in the outpatient setting that would provide a faster recovery time with minimal post-procedure amnesia This injection is used following pretreatment with fentanyl citrate for pain management
Midazolam is the most widely used iv agent for minimal-to-moderate sedation The dose range of midazolam to induce minimal to moderate sedation was based on standard clinical practice
new paragraph All patients were pre-medicated with fentanyl citrate as an analgesic
The outpatient setting has become increasingly popular for various types of medical procedures requiring sedation In outpatient minor surgical procedures sedation agents are used to provide mild-to-moderate sedation and are used with other medicines for pain management Surgeons have searched for alternative treatments to use in the outpatient setting that would provide a faster recovery time with minimal post-procedure amnesia This injection is used following pretreatment with fentanyl citrate for pain management
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