Diabetic Neuropathy Topical Treatment

April 17, 2008 updated by: Irmandade da Santa Casa de Misericordia de Sao Paulo

Diabetic Neuropathic Pain Topical Treatment- Comparative Study

Comparative study of efficacy and safety of ketamine, clonidine, mixture of both and placebo in patients with diabetic neuropathic pain

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
      • São Paulo, Brazil, 01277-900
        • Santa Casa de São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: K
drug - ketamine 1% gel
Drug: ketamine
ketamine 150 mcg/g bid
Placebo Comparator: P
vehicle gel
Drug: vehicle gel
bid - 12 weeks
Experimental: M
association of ketamine and clonidine gel
Drug: ketamine + clonidine
ketamine 150mcg/g + clonidine 1% gel bid 12 weeks
Experimental: C
clonidine gel
Drug: clonidine gel 1%
bid 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pain evaluation by visual analogue scale
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
pain evaluation by amount of rescue medication required
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Irmandade da Santa Casa de Misericordia de Sao Paulo

Investigators

  • Principal Investigator: Judymara L Gozzani, Investigator, Santa Casa de São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Anticipated)

April 1, 2009

Study Completion (Anticipated)

June 1, 2009

Study Registration Dates

First Submitted

April 15, 2008

First Submitted That Met QC Criteria

April 17, 2008

First Posted (Estimate)

April 18, 2008

Study Record Updates

Last Update Posted (Estimate)

April 18, 2008

Last Update Submitted That Met QC Criteria

April 17, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 042/2007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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