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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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