Diabetic Neuropathy Topical Treatment

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by Irmandade da Santa Casa de Misericordia de Sao Paulo.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Irmandade da Santa Casa de Misericordia de Sao Paulo
ClinicalTrials.gov Identifier:
NCT00661063
First received: April 15, 2008
Last updated: April 17, 2008
Last verified: April 2008

April 15, 2008
April 17, 2008
April 2008
April 2009   (final data collection date for primary outcome measure)
pain evaluation by visual analogue scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00661063 on ClinicalTrials.gov Archive Site
pain evaluation by amount of rescue medication required [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
200
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
Both
18 Years and older
No
Contact: Judymara L Gozzani, investigator 55-11-3884-0865 gozzani@osite.com.br
Brazil
 
NCT00661063
042/2007
Yes
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