Diabetic Neuropathy Topical Treatment

Irmandade da Santa Casa de Misericordia de Sao Paulo

Status and phase: Unknown; Phase 3

Conditions: Diabetic Neuropathy; Pain

Treatments: Drug: vehicle gel; Drug: ketamine; Drug: ketamine + clonidine; Drug: clonidine gel 1%

Study type: Interventional

Funder types: Other

Identifiers

NCT00661063

042/2007

Details and patient eligibility

About

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

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 4 patient groups, including a placebo group

K

Experimental group

Description:

drug - ketamine 1% gel

Treatment:

Drug: ketamine

P

Placebo Comparator group

Description:

vehicle gel

Treatment:

Drug: vehicle gel

M

Experimental group

Description:

association of ketamine and clonidine gel

Treatment:

Drug: ketamine + clonidine

C

Experimental group

Description:

clonidine gel

Treatment:

Drug: clonidine gel 1%