Local Anesthetic Properties of Neosaxitoxin

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2005-09-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Neosaxitoxin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes