Official Title: “Diabetic Neuropathic Pain Topical Treatment- Comparative Study”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: April 2009

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: K
  • drug - ketamine 1% gel
• Placebo Comparator: P
  • vehicle gel
• Experimental: M
  • association of ketamine and clonidine gel
• Experimental: C
  • clonidine gel

Primary Measures

• pain evaluation by visual analogue scale
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• pain evaluation by amount of rescue medication required
  • Time Frame: 12 weeks
    Safety Issue?: No

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Irmandade da Santa Casa de Misericordia de Sao Paul

Overall Clinical Trial Officials and Contacts

Judymara L Gozzani, Investigator Principal Investigator Santa Casa de São Paulo  

Overall Contact: Judymara L Gozzani, investigator 55-11-3884-0865 gozzani@osite.com.br

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00661063

Study ID Number: 042/2007

ClinicalTrials.gov Identifier: NCT00661063

Health Authority: Brazil: National Health Surveillance Agency