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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
Irmandade da Santa Casa de Misericordia de Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Neuropathy focused on measuring neuropathic pain, ketamine, clonidine, association

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
April 15, 2008
Last Updated
April 17, 2008
Sponsor
Irmandade da Santa Casa de Misericordia de Sao Paulo
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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

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Diabetic Neuropathy Topical Treatment

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