Diabetic Neuropathy Topical Treatment
Primary Purpose
Diabetic Neuropathy, Pain
Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
ketamine
vehicle gel
ketamine + clonidine
clonidine gel 1%
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Neuropathy focused on measuring neuropathic pain, ketamine, clonidine, association
Eligibility 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
Sites / Locations
- Santa Casa de São Paulo
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Experimental
Arm Label
K
P
M
C
Arm Description
drug - ketamine 1% gel
vehicle gel
association of ketamine and clonidine gel
clonidine gel
Outcomes
Primary Outcome Measures
pain evaluation by visual analogue scale
Secondary Outcome Measures
pain evaluation by amount of rescue medication required
Full Information
NCT ID
NCT00661063
First Posted
April 15, 2008
Last Updated
April 17, 2008
Sponsor
Irmandade da Santa Casa de Misericordia de Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT00661063
Brief Title
Diabetic Neuropathy Topical Treatment
Official Title
Diabetic Neuropathic Pain Topical Treatment- Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Unknown status
Study Start Date
April 2008 (undefined)
Primary Completion Date
April 2009 (Anticipated)
Study Completion Date
June 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Irmandade da Santa Casa de Misericordia de Sao Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Comparative study of efficacy and safety of ketamine, clonidine, mixture of both and placebo in patients with diabetic neuropathic pain
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathy, Pain
Keywords
neuropathic pain, ketamine, clonidine, association
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
K
Arm Type
Experimental
Arm Description
drug - ketamine 1% gel
Arm Title
P
Arm Type
Placebo Comparator
Arm Description
vehicle gel
Arm Title
M
Arm Type
Experimental
Arm Description
association of ketamine and clonidine gel
Arm Title
C
Arm Type
Experimental
Arm Description
clonidine gel
Intervention Type
Drug
Intervention Name(s)
ketamine
Intervention Description
ketamine 150 mcg/g bid
Intervention Type
Drug
Intervention Name(s)
vehicle gel
Intervention Description
bid - 12 weeks
Intervention Type
Drug
Intervention Name(s)
ketamine + clonidine
Intervention Description
ketamine 150mcg/g + clonidine 1% gel bid 12 weeks
Intervention Type
Drug
Intervention Name(s)
clonidine gel 1%
Intervention Description
bid 12 weeks
Primary Outcome Measure Information:
Title
pain evaluation by visual analogue scale
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
pain evaluation by amount of rescue medication required
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Judymara L Gozzani, investigator
Phone
55-11-3884-0865
Email
gozzani@osite.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judymara L Gozzani, Investigator
Organizational Affiliation
Santa Casa de São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Santa Casa de São Paulo
City
São Paulo
ZIP/Postal Code
01277-900
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
35587172
Citation
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.
Results Reference
derived
Learn more about this trial
Diabetic Neuropathy Topical Treatment
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