Diabetic Neuropathy Topical Treatment

Phase 3

• Conditions: Diabetic Neuropathy; Pain
• Interventions: Drug: ketamine + clonidine; Drug: vehicle gel; Drug: clonidine gel 1%; Drug: ketamine

• Registration Number: NCT00661063
• Lead Sponsor: Irmandade da Santa Casa de Misericordia de Sao Paulo

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-04
• Study Start: 2008-04
• Study First Submitted: 2008-04-15
• Study First Submitted QC: 2008-04-17
• Last Update Submitted: 2008-04-17
• Study First Posted: 2008-04-18
• Last Update Posted: 2008-04-18
• Primary Completion: 2009-04
• Study Completion: 2009-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
M	ketamine + clonidine	association of ketamine and clonidine gel
P	vehicle gel	vehicle gel
C	clonidine gel 1%	clonidine gel
K	ketamine	drug - ketamine 1% gel

Primary Outcome Measures

Name	Time	Method
pain evaluation by visual analogue scale	12 weeks

Secondary Outcome Measures

Name	Time	Method
pain evaluation by amount of rescue medication required	12 weeks

Trial Locations

Locations (1)

Santa Casa de São Paulo; 🇧🇷 São Paulo, Brazil