Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00273065
Status:
COMPLETED
Last Update Posted:
2007-02-19
First Post:
2006-01-04
Brief Title:
Local Anesthetic Properties of Neosaxitoxin
Sponsor:
University of Chile
Organization:
University of Chile
Study Overview
Official Title:
Phase 1 Study of Local Infiltration of Neosaxitoxin as a Local Anesthetic
Status:
COMPLETED
Status Verified Date:
2007-02
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 evaluate the local anesthetic properties of neosaxitoxin in humans
Detailed Description:
Neosaxitoxin is a phycotoxins that reversible block the voltage-gated sodium channels at neuronal level Its activity is express as blocking the axonal conduction stopping the propagation of the nerve impulse The objective of the present work is to evaluate the neosaxitoxin efficacy and safety as local anesthetic in a human trial
Methods Randomized double-blind placebo-controlled trial with 10 healthy volunteers The anesthetic effect will be evaluated using a standardized human sensory and pain model TSA Neurosensory analyser and Von Frey Technique will be used to evaluate five parameters sensory threshold for warm and cold pain thresholds for heat and cold and mechanical touch perception threshold
Methods Randomized double-blind placebo-controlled trial with 10 healthy volunteers The anesthetic effect will be evaluated using a standardized human sensory and pain model TSA Neurosensory analyser and Von Frey Technique will be used to evaluate five parameters sensory threshold for warm and cold pain thresholds for heat and cold and mechanical touch perception threshold
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