Diabetic Neuropathy Topical Treatment

Ketamine

Brief Summary

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

Intervention / Treatment

  • Ketamine (DRUG)
    ketamine 150 mcg/g bid
  • vehicle gel (DRUG)
    bid - 12 weeks
  • ketamine + clonidine (DRUG)
    ketamine 150mcg/g + clonidine 1% gel bid 12 weeks
  • clonidine gel 1% (DRUG)
    bid 12 weeks

Condition or Disease

  • Diabetic Neuropathy
  • Pain

Phase

Study Design

Study type: INTERVENTIONAL
Status: Unknown status
Study results: No Results Available
Age: 18 Years and older   (Adult, Older Adult)
Enrollment: 200 (ESTIMATED)
Funded by: Other
Allocation: Randomized
Primary Purpose: Treatment

Masking

Clinical Trial Dates

Start date: Apr 01, 2008
Primary Completion: Apr 01, 2009 ESTIMATED
Completion Date: Jun 01, 2009 ESTIMATED
Study First Posted: Apr 18, 2008 ESTIMATED
Results First Posted: Aug 31, 2020
Last Updated: Apr 17, 2008

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

Location

Sao Paulo, Brazil
Santa Casa de São Paulo, São Paulo, Brazil

Eligibility Criteria

Sex: All
Minimum Age: 18
Healthy Volunteers: Yes

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

Primary Outcomes
  • pain evaluation by visual analogue scale 12 weeks
Secondary Outcomes
  • pain evaluation by amount of rescue medication required 12 weeks

More Details

NCT Number: NCT00661063
Other IDs: 042/2007
Study URL: https://clinicaltrials.gov/study/NCT00661063
Last updated: Sep 29, 2023