Clinical Trial on Neosaxitoxin - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Healthy Volunteers

Intervention / Treatment

Drug: Neosaxitoxin

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.

Study Type

Interventional

Enrollment

10

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Chile
- - Santiago, Chile
    - Henry Mayer Center, Hospital Clínico Universidad de Chile

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Single Group Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chile

Investigators

Principal Investigator: Alberto Rodriguez-Navarro, MD, University of Chile
Principal Investigator: Nestor Lagos, PhD, Faculty of Medicine, University of Chile

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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. 2007 Feb;106(2):339-45. doi: 10.1097/00000542-200702000-00023.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Study Completion

September 1, 2005

Study Registration Dates

First Submitted

January 4, 2006

First Submitted That Met QC Criteria