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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.
 
ClinicalTrials.gov 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
Sponsor:
Information provided by:
Irmandade da Santa Casa de Misericordia de Sao Paulo

Tracking Information
First Submitted Date  ICMJE April 15, 2008
First Posted Date  ICMJE April 18, 2008
Last Update Posted Date April 18, 2008
Study Start Date  ICMJE April 2008
Estimated Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2008)
pain evaluation by visual analogue scale [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2008)
pain evaluation by amount of rescue medication required [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Diabetic Neuropathy Topical Treatment
Official Title  ICMJE 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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetic Neuropathy
  • Pain
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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%
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 17, 2008)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2009
Estimated Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00661063
Other Study ID Numbers  ICMJE 042/2007
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Judymara Lauzi Gozzani PhD, ISCMSP
Study Sponsor  ICMJE Irmandade da Santa Casa de Misericordia de Sao Paulo
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Judymara L Gozzani, Investigator Santa Casa de São Paulo
PRS Account Irmandade da Santa Casa de Misericordia de Sao Paulo
Verification Date April 2008

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