CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed
Drug / intervention
Amitriptylinedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00355277
NCT00355277Phase 1Completed

Local Anaesthetic Effects of Transcutaneous Amitriptyline in Human Volunteers : a Controlled, Double-blinded, Randomised Study Versus Placebo and Transcutaneous Local Anaesthetic (EMLA(R))

University Hospital, Clermont-Ferrand·interventional·Posted Jul 21, 2006·Updated Apr 4, 2013

In Brief

A Phase 1 clinical trial evaluating Amitriptyline for Healthy Volunteers. Completed, across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

Phase 1CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 21, 2006
Enrollment StartNov 1, 2005
Study CompletionDec 1, 2007
TodayJul 2, 2026
Posted 19.9 years ago

Interventions

Amitriptylinedrug