Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00235976
Status:
COMPLETED
Last Update Posted:
2006-07-21
First Post:
2005-10-07
Brief Title:
The Efficacy and Safety of Gantacurium Chloride for Injection in Tracheal Intubation in Healthy Adult Patients Undergoing Surgery Under General Anesthesia
Sponsor:
Avera Pharmaceuticals
Organization:
Avera Pharmaceuticals
Study Overview
Official Title:
A Multicenter Randomized Controlled Observer-Blinded Dose-Response Study to Evaluate the Efficacy in Tracheal Intubation and Safety of Gantacurium Chloride for Injection in Healthy Adult Patients Undergoing Surgery With General Anesthesia
Status:
COMPLETED
Status Verified Date:
2006-07
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:
This is a multicenter randomized controlled observer-blinded dose-response study to evaluate the efficacy in tracheal intubation and safety of gantacurium chloride for injection in healthy adult patients undergoing surgery with general anesthesia
Gantacurium chloride for injection previously referred to as AV430A is a new investigational non-depolarizing ultra-short acting neuromuscular blocking agent NMB Preliminary results in animals and healthy human subjects Phase 1 studies in adult volunteers suggest that gantacurium chloride for injection may provide a useful adjunct to general anesthesia by permitting rapid intubation This Phase 2 study will provide more definitive information on the ultra-short acting profile of the compound by determining the quality of intubation in patients at 60 seconds as assessed by a blinded intubator In addition the safety of the compound will be assessed In this study the efficacy and safety of gantacurium chloride for injection will also be compared to a reference drug succinylcholine and to placebo
The primary objective of this study is to determine the dose-response relationship of gantacurium chloride for injection on tracheal intubation conditions after a single rapid bolus intravenous iv dose as a component of a propofolopioid induction-intubation sequence and to assess the safety profile of this compound
Gantacurium chloride for injection previously referred to as AV430A is a new investigational non-depolarizing ultra-short acting neuromuscular blocking agent NMB Preliminary results in animals and healthy human subjects Phase 1 studies in adult volunteers suggest that gantacurium chloride for injection may provide a useful adjunct to general anesthesia by permitting rapid intubation This Phase 2 study will provide more definitive information on the ultra-short acting profile of the compound by determining the quality of intubation in patients at 60 seconds as assessed by a blinded intubator In addition the safety of the compound will be assessed In this study the efficacy and safety of gantacurium chloride for injection will also be compared to a reference drug succinylcholine and to placebo
The primary objective of this study is to determine the dose-response relationship of gantacurium chloride for injection on tracheal intubation conditions after a single rapid bolus intravenous iv dose as a component of a propofolopioid induction-intubation sequence and to assess the safety profile of this compound
Detailed Description:
None
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