Diabetic Neuropathy Topical Treatment
Information source: Irmandade da Santa Casa de Misericordia de Sao Paulo
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetic Neuropathy; Pain
Intervention: ketamine (Drug); vehicle gel (Drug); ketamine + clonidine (Drug); clonidine gel 1% (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Irmandade da Santa Casa de Misericordia de Sao Paulo Official(s) and/or principal investigator(s):
Judymara L Gozzani, Investigator, Principal Investigator, Affiliation: Santa Casa de São Paulo
Overall contact:
Judymara L Gozzani, investigator, Phone: 55-11-3884-0865, Email: gozzani@osite.com.br
Summary
Comparative study of efficacy and safety of ketamine, clonidine, mixture of both and placebo
in patients with diabetic neuropathic pain
Clinical Details
Official title: Diabetic Neuropathic Pain Topical Treatment- Comparative Study
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: pain evaluation by visual analogue scale
Secondary outcome: pain evaluation by amount of rescue medication required
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Judymara L Gozzani, investigator, Phone: 55-11-3884-0865, Email: gozzani@osite.com.br
Santa Casa de São Paulo, São Paulo 01277-900, Brazil; Not yet recruiting
Additional Information
Starting date: April 2008
Last updated: April 17, 2008
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