Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
200 participants
INTERVENTIONAL
2008-04-30
2009-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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K
drug - ketamine 1% gel
ketamine
ketamine 150 mcg/g bid
P
vehicle gel
vehicle gel
bid - 12 weeks
M
association of ketamine and clonidine gel
ketamine + clonidine
ketamine 150mcg/g + clonidine 1% gel bid 12 weeks
C
clonidine gel
clonidine gel 1%
bid 12 weeks
Interventions
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ketamine
ketamine 150 mcg/g bid
vehicle gel
bid - 12 weeks
ketamine + clonidine
ketamine 150mcg/g + clonidine 1% gel bid 12 weeks
clonidine gel 1%
bid 12 weeks
Eligibility Criteria
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Inclusion Criteria
* Mono or polyneuropathy
* Treatment with Tricyclic Antidepressant, Carbamazepine during 3 weeks at least
* Preserved cognition
Exclusion Criteria
* Pregnancy
* Breast feeding
18 Years
ALL
No
Sponsors
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Irmandade da Santa Casa de Misericordia de Sao Paulo
OTHER
Responsible Party
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ISCMSP
Principal Investigators
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Judymara L Gozzani, Investigator
Role: PRINCIPAL_INVESTIGATOR
Santa Casa de São Paulo
Locations
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Santa Casa de São Paulo
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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References
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Serednicki WT, Wrzosek A, Woron J, Garlicki J, Dobrogowski J, Jakowicka-Wordliczek J, Wordliczek J, Zajaczkowska R. Topical clonidine for neuropathic pain in adults. Cochrane Database Syst Rev. 2022 May 19;5(5):CD010967. doi: 10.1002/14651858.CD010967.pub3.
Other Identifiers
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042/2007
Identifier Type: -
Identifier Source: org_study_id