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Diabetic Neuropathy Topical Treatment

This study is not yet open for participant recruitment.
Study NCT00661063.   Last updated on April 17, 2008.   Information provided by Irmandade da Santa Casa de Misericordia de Sao Paul

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Descriptive Information Fields
Brief Title  Diabetic Neuropathy Topical Treatment
Official Title  Diabetic Neuropathic Pain Topical Treatment- Comparative Study
Brief Summary

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

Detailed Description
Study Phase Phase III
Study Type  Interventional
Study Design  Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure  pain evaluation by visual analogue scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measure  pain evaluation by amount of rescue medication required [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Condition  Diabetic Neuropathy
Pain
Intervention  Drug: ketamine
Drug: vehicle gel
Drug: ketamine + clonidine
Drug: clonidine gel 1%
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Not yet recruiting
Enrollment  200
Start Date  April 2008
Completion Date June 2009
Eligibility Criteria 

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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: Judymara L Gozzani, investigator     55-11-3884-0865     gozzani@osite.com.br    
Location Countries  Brazil
Administrative Information Fields
NCT ID  NCT00661063
Organization ID 042/2007
Secondary IDs ††
Study Sponsor  Irmandade da Santa Casa de Misericordia de Sao Paul
Collaborators ††
Investigators 
Principal Investigator:     Judymara L Gozzani, Investigator     Santa Casa de São Paulo    
Information Provided By Irmandade da Santa Casa de Misericordia de Sao Paul
Verification Date April 2008
First Received Date  April 15, 2008
Last Updated Date April 17, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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