ANALGESIC RESPONSE TO TRANSDERMAL LIDOCAINE IN PATIENTS WITH PAINFUL PERIPHERAL DIABETIC NEUROPATHY UNDERLYING DIFFERENT SENSORY PATTERNS - transdermal lidocaine

Phase 1

• Conditions: In this study the effect of transdermal lidocaine in patients with painful peripheral diabetic neuropathy will be examined.

• Registration Number: EUCTR2009-013706-13-AT
• Lead Sponsor: Wilhelminenspital der Stadt Wien

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-03
• Last Update Posted: 12 December 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

- subjects of at least 18 years of age;
- subjects who have given there written informet consent;
- at baseline female subjects of child bearing potential must be using adequate contraception and must have a negative urine pregnancy test;
- pain due to peripherial polyneuropathy at the lower extremities with duration of > = 3 months, whose pain is not adequately controlled (subjects with average pain of >= 4 on a numerical rating scale( 0-10), 0 is no pain, 10 is worst imaginable pain)
- intact skin surfacen at the potential patch application sites
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- pregnant or brest feeding subjects
- contraindications to versatis
- patiens with severe cardiac disorders ( NYHA >3)
- subjects with alcohol or drug abuse or addictive personality
- subjects with significant psyciatric disorder
- subjects receiving antipsychotic medication
- subjects for whom a treatement could alter the degree or nature of pain
- subjects who received investigational drug or used investigational device in thirty days prior to studie entry
-subjects known to have a condition that in the investigators judgement precludes participation in the studie
- subjects unable to comply with the study assessments and to complete the questionnaires
- subjects with peripheral vascular disease = III following the Fontaine Classification
- subjects with history of slow-healing diabetic foot ulcers or current skin or soft tissue lesions on the foot that will interfere with application of the lidocaine patch and or skin biopsies

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified