Diabetic Neuropathy Topical Treatment

Irmandade da Santa Casa de Misericordia de Sao Paulo200 enrolled

Overview

Comparative study of efficacy and safety of ketamine, clonidine, mixture of both and placebo in patients with diabetic neuropathic pain

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

200

Conditions

Diabetic Neuropathy Pain

Interventions

ketamineDRUG

ketamine 150 mcg/g bid

vehicle gelDRUG

bid - 12 weeks

ketamine + clonidineDRUG

ketamine 150mcg/g + clonidine 1% gel bid 12 weeks

clonidine gel 1%

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diabetes Mellitus type I or II * Mono or polyneuropathy * Treatment with Tricyclic Antidepressant, Carbamazepine during 3 weeks at least * Preserved cognition Exclusion Criteria: * Ulcerative or infection or vesicle lesion in pain site * Pregnancy * Breast feeding

Locations (1)

Santa Casa de São Paulo

São Paulo, São Paulo, Brazil

Outcomes

Primary Outcomes

pain evaluation by visual analogue scale

Time frame: 12 weeks

Secondary Outcomes

pain evaluation by amount of rescue medication required

Time frame: 12 weeks

Central Contacts

Judymara L Gozzani, investigator

CONTACT

55-11-3884-0865 gozzani@osite.com.br

Data from ClinicalTrials.gov

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