Local Anaesthetic Effects of Transcutaneous Amitriptyline

NCT00355277 | Completed Phase 1

• 1 other identifier: CHU63-0014
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Tricyclic antidepressants; Neuropathic pain; Local anaesthesia; Transcutaneous

Interventions

Amitriptyline DRUG

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

Centre de Pharmacologie Clinique /Cic

Clermont-Ferrand, Auvergne, 63003, France

Location

Related Publications (4)

• 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.

  PMID: 2761713 BACKGROUND

• 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.

  PMID: 11212590 BACKGROUND

• 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.

  PMID: 9121808 BACKGROUND

• 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.

  PMID: 18362604 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Neuralgia

Interventions

Amitriptyline

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Claude DUBRAY, Pr

  CENTRE DE PHARMACOLOGIE CLINIQUE

  PRINCIPAL INVESTIGATOR

• Christian DUALE, Dr

  CENTRE DE PHARMACOLOGIE CLINIQUE

  STUDY DIRECTOR

• PICKERING gisele, Dr

  CENTRE DE PHARMACOLOGIE CLINIQUE

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 20, 2006
• First Posted: July 21, 2006
• Study Start: November 1, 2005
• Study Completion: December 1, 2007
• Last Updated: April 4, 2013

Record last verified: 2013-04

Locations

FR (1)