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NCT00661063 Clinical Trial

Diabetic Neuropathy Topical Treatment

Pain Clinical Trial

Official title:
Diabetic Neuropathic Pain Topical Treatment- Comparative Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT00661063
Other study ID # 042/2007
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received April 15, 2008
Last updated April 17, 2008
Start date April 2008
Est. completion date June 2009

Study information
Verified date April 2008
Source Irmandade da Santa Casa de Misericordia de Sao Paulo
Contact Judymara L Gozzani, investigator
Phone 55-11-3884-0865
Email gozzani@osite.com.br
Is FDA regulated No
Health authority Brazil: National Health Surveillance Agency
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 200
Est. completion date June 2009
Est. primary completion date April 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• ketamine
ketamine 150 mcg/g bid
• vehicle gel
bid - 12 weeks
• ketamine + clonidine
ketamine 150mcg/g + clonidine 1% gel bid 12 weeks
• clonidine gel 1%
bid 12 weeks

Locations
Country Name City State
Brazil Santa Casa de São Paulo São Paulo

Sponsors (1)
Lead Sponsor Collaborator
Irmandade da Santa Casa de Misericordia de Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary pain evaluation by visual analogue scale 12 weeks No
Secondary pain evaluation by amount of rescue medication required 12 weeks No
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