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Local Anaesthetic Effects of Transcutaneous Amitriptyline

NCT00355277 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2013-04-04

No results posted yet for this study

Summary

The aim of this study is to assess the local anaesthetic effects of amitriptyline applied on the skin of human volunteers, considering the differential effects on mechanic and thermic sensitivity, the local and general tolerance, and the systemic absorption of the drug. The solution used for dilution of amitriptyline is the only one known to allow transcutaneous absorption of the drug \[1\]. Considering that the peripheral sensitive fibre is a possible site of action of tricyclic antidepressants for relieving neuropathic pain \[2,3\], this is a first step study before further assessment of the therapeutic effects of transcutaneous amitriptyline.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Amitriptyline

Sponsors & Collaborators

  • University Hospital, Clermont-Ferrand

    lead OTHER

Principal Investigators

  • Claude DUBRAY, Pr · CENTRE DE PHARMACOLOGIE CLINIQUE

  • Christian DUALE, Dr · CENTRE DE PHARMACOLOGIE CLINIQUE

  • PICKERING gisele, Dr · CENTRE DE PHARMACOLOGIE CLINIQUE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-11-30
Completion
2007-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00355277 on ClinicalTrials.gov