Local Anaesthetic Effects of Transcutaneous Amitriptyline - Full Text View

Purpose

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	Intervention	Phase
Healthy Volunteers	Drug: Amitriptyline	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind 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))

Resource links provided by NLM:

MedlinePlus related topics: Antidepressants

Drug Information available for: Amitriptyline Amitriptyline hydrochloride Triavil

U.S. FDA Resources

Further study details as provided by University Hospital, Clermont-Ferrand:

Estimated Enrollment:	16
Study Start Date:	November 2005
Estimated Study Completion Date:	December 2007

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.

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy volunteers

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00355277

Locations

France
Centre de Pharmacologie Clinique /Cic
Clermont-ferrand, Auvergne, France, 63003

Sponsors and Collaborators

University Hospital, Clermont-Ferrand

Investigators

Principal Investigator:	Claude DUBRAY, Pr	CENTRE DE PHARMACOLOGIE CLINIQUE
Study Director:	Christian DUALE, Dr	CENTRE DE PHARMACOLOGIE CLINIQUE
Study Director:	PICKERING gisele, Dr	CENTRE DE PHARMACOLOGIE CLINIQUE

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

Publications:

Dualé C, Daveau J, Cardot JM, Boyer-Grand A, Schoeffler P, Dubray C. Cutaneous amitriptyline in human volunteers: differential effects on the components of sensory information. Anesthesiology. 2008 Apr;108(4):714-21. doi: 10.1097/ALN.0b013e3181672632.

Kissin I, McDanal J, Xavier AV. Topical lidocaine for relief of superficial pain in postherpetic neuralgia. Neurology. 1989 Aug;39(8):1132-3. No abstract available.

Sawynok J, Esser MJ, Reid AR. Antidepressants as analgesics: an overview of central and peripheral mechanisms of action. J Psychiatry Neurosci. 2001 Jan;26(1):21-9. Review.

McQuay HJ, Tramer M, Nye BA, Carroll D, Wiffen PJ, Moore RA. A systematic review of antidepressants in neuropathic pain. Pain. 1996 Dec;68(2-3):217-27.

ClinicalTrials.gov Identifier:	NCT00355277 History of Changes
Other Study ID Numbers:	CHU63-0014
Study First Received:	July 20, 2006
Last Updated:	April 2, 2013
Health Authority:	France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:

Tricyclic antidepressants
Neuropathic pain
Local anaesthesia
Transcutaneous

Additional relevant MeSH terms:

Amitriptyline
Antidepressive Agents, Tricyclic
Amitriptyline, perphenazine drug combination
Anesthetics, Local
Anesthetics
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics

Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants

ClinicalTrials.gov processed this record on May 23, 2013