Local Anesthetic Properties of Neosaxitoxin

Healthy Volunteers Clinical Trial

Official title:

Phase 1 Study of Local Infiltration of Neosaxitoxin as a Local Anesthetic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00273065
• Other study ID #: HCUCH-AR-NEOSAX-0001
• Status: Completed
• Phase: Phase 1
• First received: January 4, 2006
• Last updated: February 16, 2007
• Start date: May 2005
• Est. completion date: September 2005

Study information

• Verified date: February 2007
• Source: University of Chile
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Instituto de Salud Pública de Chile
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Neosaxitoxin

Locations

Country	Name	City	State
Chile	Henry Mayer Center, Hospital Clínico Universidad de Chile	Santiago

Sponsors (1)

Lead Sponsor	Collaborator
University of Chile

Country where clinical trial is conducted

Chile, 

References & Publications (1)

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. 200 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neural blockade of five parameters:
Primary	sensory threshold for warm
Primary	sensory threshold for cold
Primary	pain thresholds for heat
Primary	pain thresholds for cold
Primary	mechanical touch perception threshold
Primary	Measurements at 1,3,6,9,12,16,24 and 48 hrs after the injections
Secondary	Pain on injection (VAS Score 0-10)
Secondary	Blood sample at 1 hour
Secondary	Orine sample at 4 hours after the injection, in order to determine amounts of neosaxitoxin