Local Anesthetic Properties of Neosaxitoxin

This study has been completed.
Sponsor:
Information provided by:
University of Chile
ClinicalTrials.gov Identifier:
NCT00273065
First received: January 4, 2006
Last updated: February 16, 2007
Last verified: February 2007

January 4, 2006
February 16, 2007
May 2005
Not Provided
  • Neural blockade of five parameters:
  • sensory threshold for warm
  • sensory threshold for cold
  • pain thresholds for heat
  • pain thresholds for cold
  • mechanical touch perception threshold
  • Measurements at 1,3,6,9,12,16,24 and 48 hrs after the injections
Same as current
Complete list of historical versions of study NCT00273065 on ClinicalTrials.gov Archive Site
  • Pain on injection (VAS Score 0-10)
  • Blood sample at 1 hour
  • Orine sample at 4 hours after the injection, in order to determine amounts of neosaxitoxin
Same as current
Not Provided
Not Provided
 
Local Anesthetic Properties of Neosaxitoxin
Phase 1 Study of Local Infiltration of Neosaxitoxin as a Local Anesthetic

The purpose of this study is to evaluate the local anesthetic properties of neosaxitoxin in humans

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Healthy Volunteers
Drug: Neosaxitoxin
Not Provided
Rodriguez-Navarro AJ, Lagos N, Lagos M, Braghetto I, Csendes A, Hamilton J, Figueroa C, Truan D, Garcia C, Rojas A, Iglesias V, Brunet L, Alvarez F. Neosaxitoxin as a local anesthetic: preliminary observations from a first human trial. Anesthesiology. 2007 Feb;106(2):339-45.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
September 2005
Not Provided

Inclusion Criteria:

  • Healthy males with the abilities to understand and respond the tests to perform

Exclusion Criteria:

  • Use of any oral analgesics at least ten days before the study
  • Drugs abuse history
  • Showing at the clinical examination any signal of psychiatric disorder
Male
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Chile
 
NCT00273065
HCUCH-AR-NEOSAX-0001
Not Provided
Not Provided
University of Chile
Not Provided
Principal Investigator: Alberto Rodriguez-Navarro, MD University of Chile
Principal Investigator: Nestor Lagos, PhD Faculty of Medicine, University of Chile
University of Chile
February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP