Local Anaesthetic Effects of Transcutaneous Amitriptyline

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

Study Description

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.

Study Design

• 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

Arms and Interventions

Outcome Measures

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes 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

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 

Publications of Results:

Duale 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.

Other Publications:

Kissin I, McDanal J, Xavier AV. Topical lidocaine for relief of superficial pain in postherpetic neuralgia. Neurology. 1989 Aug;39(8):1132-3. doi: 10.1212/wnl.39.8.1132-a. 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.

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. doi: 10.1016/s0304-3959(96)03140-5.

• ClinicalTrials.gov Identifier: NCT00355277
• Other Study ID Numbers: CHU63-0014
• First Posted: July 21, 2006
• Last Update Posted: April 4, 2013
• Last Verified: April 2013

Keywords provided by University Hospital, Clermont-Ferrand:

Tricyclic antidepressants; Neuropathic pain; Local anaesthesia; Transcutaneous

Additional relevant MeSH terms:

Amitriptyline; Antidepressive Agents, Tricyclic; Antidepressive Agents; Psychotropic Drugs; Analgesics, Non-Narcotic; Analgesics; 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