Diabetic Neuropathy Topical Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00661063
Recruitment Status : Unknown
Verified April 2008 by Irmandade da Santa Casa de Misericordia de Sao Paulo.
Recruitment status was:  Not yet recruiting
First Posted : April 18, 2008
Last Update Posted : April 18, 2008
Information provided by:
Irmandade da Santa Casa de Misericordia de Sao Paulo

April 15, 2008
April 18, 2008
April 18, 2008
April 2008
April 2009   (Final data collection date for primary outcome measure)
pain evaluation by visual analogue scale [ Time Frame: 12 weeks ]
Same as current
No Changes Posted
pain evaluation by amount of rescue medication required [ Time Frame: 12 weeks ]
Same as current
Not Provided
Not Provided
Diabetic Neuropathy Topical Treatment
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
Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Diabetic Neuropathy
  • Pain
  • 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
  • Experimental: K
    drug - ketamine 1% gel
    Intervention: Drug: ketamine
  • Placebo Comparator: P
    vehicle gel
    Intervention: Drug: vehicle gel
  • Experimental: M
    association of ketamine and clonidine gel
    Intervention: Drug: ketamine + clonidine
  • Experimental: C
    clonidine gel
    Intervention: Drug: clonidine gel 1%
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
June 2009
April 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Judymara Lauzi Gozzani PhD, ISCMSP
Irmandade da Santa Casa de Misericordia de Sao Paulo
Not Provided
Principal Investigator: Judymara L Gozzani, Investigator Santa Casa de São Paulo
Irmandade da Santa Casa de Misericordia de Sao Paulo
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP