NCT00273065

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1 healthy-volunteers

Timeline
Completed

Started May 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 9, 2006

Completed
Last Updated

February 19, 2007

Status Verified

February 1, 2007

First QC Date

January 4, 2006

Last Update Submit

February 16, 2007

Conditions

Healthy Volunteers

Keywords

Local AnestheticNeosaxitoxin

Outcome Measures

Primary Outcomes (7)

  • 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 Outcomes (3)

  • 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

Interventions

NeosaxitoxinDRUG

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy males with the abilities to understand and respond the tests to perform

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Mayer Center, Hospital Clínico Universidad de Chile

Santiago, Santiago Metropolitan, 0, Chile

Location

Related Publications (1)

  • 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.

    PMID: 17264729RESULT

MeSH Terms

Interventions

neosaxitoxin

Study Officials

  • Alberto Rodriguez-Navarro, MD

    University of Chile

    PRINCIPAL INVESTIGATOR

  • Nestor Lagos, PhD

    Faculty of Medicine, University of Chile

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 4, 2006

First Posted

January 9, 2006

Study Start

May 1, 2005

Study Completion

September 1, 2005

Last Updated

February 19, 2007

Record last verified: 2007-02

Locations

CL(1)