Local Anesthetic Properties of Neosaxitoxin

University of Chile

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Neosaxitoxin

Study type: Interventional

Funder types: Other

Identifiers

NCT00273065

HCUCH-AR-NEOSAX-0001

Details and patient eligibility

About

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

Full 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.

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind