Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00125398
Status:
COMPLETED
Last Update Posted:
2008-11-07
First Post:
2005-07-28
Brief Title:
GPI 15715 For Sedation in the Intensive Care Unit ICU Setting
Sponsor:
Eisai Inc
Organization:
Eisai Inc
Study Overview
Official Title:
A Phase II Randomized Open-Label Study to Examine the Safety and Efficacy of GPI 15715 for Sedation of Patients Requiring Intubation and Mechanical Ventilation in the Intensive Care Unit Setting
Status:
COMPLETED
Status Verified Date:
2008-11
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:
Patients who are in the intensive care unit after surgery and require mechanical breathing support intubation and ventilation usually require sedation to avoid agitation and excessive stress responses Short-acting sedatives such as midazolam and propofol are the drugs typically used for this Propofol provides for fast sedation and fast recovery from sedation Midazolam is slower to sedation and slower for recovery but may provide some advantages over propofol such as a lower incidence of hypotension low blood pressure This study will look at propofol compared to a product with fast sedation and recovery like that of propofol but with less of a chance for hypotension like with midazolam Patients will be treated with the product for up to 8 hours and then will be monitored for 8 hours following treatment
Detailed Description:
Patients who are intubated and ventilated and will require up to 8 hours of sedation in the ICU are eligible for participation in this study Patients will be randomized to receive 1 of 3 treatments One treatment is standard of care a propofol infusion The other two treatment arms are infusions of GPI 15715 AQUAVAN one with a bolus and one without
Patients will be treated for up to 8 hours and monitored for eight hours post treatment If there are signs of agitation during the up to 8 hour treatment period the infusion of the sedative medicine will be increased according to protocol
Blood samples will be obtained periodically during the course of the study for safety evaluation and pharmacokinetic assessments When the patient is ready for extubation or the end of the 8 hour study period has been reached the infusion of the sedative agent will be discontinued and the patient will be monitored for 8 hours post treatment
Guilford Pharmaceuticals was acquired by MGI PHARMA on October 3 2005
Patients will be treated for up to 8 hours and monitored for eight hours post treatment If there are signs of agitation during the up to 8 hour treatment period the infusion of the sedative medicine will be increased according to protocol
Blood samples will be obtained periodically during the course of the study for safety evaluation and pharmacokinetic assessments When the patient is ready for extubation or the end of the 8 hour study period has been reached the infusion of the sedative agent will be discontinued and the patient will be monitored for 8 hours post treatment
Guilford Pharmaceuticals was acquired by MGI PHARMA on October 3 2005
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Sedation in an ICU Setting | None | None | None |
| GPI 3000-0413 | None | None | None |