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Local Anesthetic Properties of Neosaxitoxin

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00273065
First Posted: January 9, 2006
Last Update Posted: February 19, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Chile
  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
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Phase 1 Study of Local Infiltration of Neosaxitoxin as a Local Anesthetic

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: January 4, 2006
First Posted: January 9, 2006
Last Update Posted: February 19, 2007
Last Verified: February 2007

Keywords provided by University of Chile:
Local Anesthetic
Neosaxitoxin

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