Diabetic Neuropathy, Pain
Conditions
Keywords
neuropathic pain, ketamine, clonidine, association
Brief summary
Comparative study of efficacy and safety of ketamine, clonidine, mixture of both and placebo in patients with diabetic neuropathic pain
Interventions
DRUGketamine
ketamine 150 mcg/g bid
DRUGvehicle gel
bid - 12 weeks
DRUGketamine + clonidine
ketamine 150mcg/g + clonidine 1% gel bid 12 weeks
DRUGclonidine gel 1%
bid 12 weeks
Sponsors
Irmandade da Santa Casa de Misericordia de Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pain evaluation by visual analogue scale | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| pain evaluation by amount of rescue medication required | 12 weeks |
Countries
Brazil
Contacts
Primary ContactJudymara L Gozzani, investigator
Outcome results
None listed