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Local Anaesthetic Effects of Transcutaneous Amitriptyline

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ClinicalTrials.gov Identifier: NCT00355277
Recruitment Status : Completed
First Posted : July 21, 2006
Last Update Posted : April 4, 2013
Information provided by:
University Hospital, Clermont-Ferrand

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Amitriptyline Phase 1

Detailed Description:
Sixteen male healthy volunteers are enrolled for this study. They receive in a randomised order on six regions of dorsal skin (after previous targetting by ink marks) the six following treatments : lidocaïne-prilocaïne anaesthetic cream (EMLA (R)), normal saline, amityptiline hydrochloride diluted in solution of water (%), isopropanol (%) , glycerol (%), titrated with sodium hydroxide for pH=8.5, at four different concentrations (0,25, 50 and 100 mM). The person in charge of local application does not participate to further examination. Immediately after one hour of application, the volunteer is examined, and then every 2 hours during 8 hours, and 24 hours after the end if application. Every trial includes, for every treated area, (a) measurement of sensitive and nociceptive threshold to Von Frey hair application, (b) assessment of sensation induced by cold and heat after Rolltemp TM application, (c) measurement of sensitive threshold to cold, then sensitive and nociceptive thresholds to heat with Thermotest TM, (d) clinical evaluation of tolerance to the treatment, (e) blood sampling for measuring amitriptylinemia (HPLC). The possible residual anaesthetic effects of the treatment are assessed one and three weeks after the application, by measurement of sensitive and nociceptive threshold to Von Frey hair application. The statistical analysis will use two-way ANOVA, considering the following factors : treatment, time, order, subject, subject/order.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Local Anaesthetic Effects of Transcutaneous Amitriptyline in Human Volunteers : a Controlled, Double-blinded, Randomised Study Versus Placebo and Transcutaneous Local Anaesthetic (EMLA(R))
Study Start Date : November 2005
Study Completion Date : December 2007

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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy volunteers

Exclusion Criteria:

  • history of intolerance to amitriptyline, lidocaine or prilocaine
  • cardiac predisposition to intolerance to tricyclic antidepressants

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00355277

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Centre de Pharmacologie Clinique /Cic
Clermont-ferrand, Auvergne, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
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Additional Information:
Publications of Results:
Other Publications:
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ClinicalTrials.gov Identifier: NCT00355277    
Other Study ID Numbers: CHU63-0014
First Posted: July 21, 2006    Key Record Dates
Last Update Posted: April 4, 2013
Last Verified: April 2013
Keywords provided by University Hospital, Clermont-Ferrand:
Tricyclic antidepressants
Neuropathic pain
Local anaesthesia
Additional relevant MeSH terms:
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Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents