Skip to main content
OpenTrials
Completed

NCT Number: NCT00273065

Local Anesthetic Properties of Neosaxitoxin

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Volunteers

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Henry Mayer Center, Hospital Clínico Universidad de Chile

Santiago, Santiago Metropolitan, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neosaxitoxin

Drug

Primary outcomes

  1. Neural blockade of five parameters:

  2. sensory threshold for warm

  3. sensory threshold for cold

  4. pain thresholds for heat

  5. pain thresholds for cold

  6. mechanical touch perception threshold

  7. Measurements at 1,3,6,9,12,16,24 and 48 hrs after the injections

Secondary outcomes

  1. Pain on injection (VAS Score 0-10)

  2. Blood sample at 1 hour

  3. Orine sample at 4 hours after the injection, in order to determine amounts of neosaxitoxin

Sponsors and collaborators

Lead sponsor

University of Chile

Other

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2005
First posted
Jan 9, 2006
Registry last updated
Feb 19, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.