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| Sponsored by: |
University of Chile |
|---|---|
| Information provided by: | University of Chile |
| ClinicalTrials.gov Identifier: | NCT00273065 |
Purpose
The purpose of this study is to evaluate the local anesthetic properties of neosaxitoxin in humans
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy Volunteers |
Drug: Neosaxitoxin |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Phase 1 Study of Local Infiltration of Neosaxitoxin as a Local Anesthetic |
| Estimated Enrollment: | 10 |
| Study Start Date: | May 2005 |
| Estimated Study Completion Date: | September 2005 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Chile | |
| Henry Mayer Center, Hospital Clínico Universidad de Chile | |
| Santiago, Chile, 0 | |
| Principal Investigator: | Alberto Rodriguez-Navarro, MD | University of Chile |
| Principal Investigator: | Nestor Lagos, PhD | Faculty of Medicine, University of Chile |
More Information
| Study ID Numbers: | HCUCH-AR-NEOSAX-0001 |
| Study First Received: | January 4, 2006 |
| Last Updated: | February 16, 2007 |
| ClinicalTrials.gov Identifier: | NCT00273065 History of Changes |
| Health Authority: | Chile: Instituto de Salud Publica de Chile |
|
Local Anesthetic Neosaxitoxin |
|
Neosaxitoxin Central Nervous System Depressants Anesthetics Neuromuscular Blocking Agents |
Peripheral Nervous System Agents Healthy Anesthetics, Local |
|
Sensory System Agents Therapeutic Uses Neosaxitoxin Physiological Effects of Drugs Central Nervous System Depressants Anesthetics |
Neuromuscular Agents Neuromuscular Blocking Agents Peripheral Nervous System Agents Central Nervous System Agents Pharmacologic Actions Anesthetics, Local |
