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
  Purpose

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


Condition Intervention Phase
Healthy Volunteers
Drug: Neosaxitoxin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Phase 1 Study of Local Infiltration of Neosaxitoxin as a Local Anesthetic

Further study details as provided by University of Chile:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 10
Study Start Date: May 2005
Estimated Study Completion Date: September 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00273065

Locations
Chile
Henry Mayer Center, Hospital Clínico Universidad de Chile
Santiago, Chile, 0
Sponsors and Collaborators
University of Chile
Investigators
Principal Investigator: Alberto Rodriguez-Navarro, MD University of Chile
Principal Investigator: Nestor Lagos, PhD Faculty of Medicine, University of Chile
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00273065     History of Changes
Other Study ID Numbers: HCUCH-AR-NEOSAX-0001
Study First Received: January 4, 2006
Last Updated: February 16, 2007
Health Authority: Chile: Instituto de Salud Pública de Chile

Keywords provided by University of Chile:
Local Anesthetic
Neosaxitoxin

Additional relevant MeSH terms:
Anesthetics
Anesthetics, Local
Neosaxitoxin
Central Nervous System Agents
Central Nervous System Depressants
Neuromuscular Agents
Neuromuscular Blocking Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014