Diabetic Neuropathy Topical Treatment

This study is not yet open for participant recruitment.

Verified by Irmandade da Santa Casa de Misericordia de Sao Paul, April 2008

First Received: April 15, 2008 Last Updated: April 17, 2008 History of Changes

Sponsor:	Irmandade da Santa Casa de Misericordia de Sao Paul
Information provided by:	Irmandade da Santa Casa de Misericordia de Sao Paul
ClinicalTrials.gov Identifier:	NCT00661063

Purpose

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

Condition	Intervention	Phase
Diabetic Neuropathy Pain	Drug: ketamine Drug: vehicle gel Drug: ketamine + clonidine Drug: clonidine gel 1%	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Diabetic Neuropathic Pain Topical Treatment- Comparative Study

Resource links provided by NLM:

MedlinePlus related topics: Diabetic Nerve Problems

Drug Information available for: Ketamine hydrochloride Clonidine Clonidine hydrochloride Ketamine

U.S. FDA Resources

Further study details as provided by Irmandade da Santa Casa de Misericordia de Sao Paul:

Primary Outcome Measures:

pain evaluation by visual analogue scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

pain evaluation by amount of rescue medication required [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	April 2008
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
K: Experimental drug - ketamine 1% gel	Drug: ketamine ketamine 150 mcg/g bid
P: Placebo Comparator vehicle gel	Drug: vehicle gel bid - 12 weeks
M: Experimental association of ketamine and clonidine gel	Drug: ketamine + clonidine ketamine 150mcg/g + clonidine 1% gel bid 12 weeks
C: Experimental clonidine gel	Drug: clonidine gel 1% bid 12 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00661063

Contacts

Contact: Judymara L Gozzani, investigator

55-11-3884-0865

gozzani@osite.com.br

Locations

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

Sponsors and Collaborators

Irmandade da Santa Casa de Misericordia de Sao Paul

Investigators

Principal Investigator:

Judymara L Gozzani, Investigator

Santa Casa de São Paulo

More Information

No publications provided

Responsible Party:	ISCMSP ( Judymara Lauzi Gozzani PhD )
Study ID Numbers:	042/2007
Study First Received:	April 15, 2008
Last Updated:	April 17, 2008
ClinicalTrials.gov Identifier:	NCT00661063 History of Changes
Health Authority:	Brazil: National Health Surveillance Agency

Keywords provided by Irmandade da Santa Casa de Misericordia de Sao Paul:

neuropathic pain
ketamine
clonidine
association

Additional relevant MeSH terms:

Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anesthetics
Excitatory Amino Acid Agents
Adrenergic Agonists
Neuromuscular Diseases
Sensory System Agents
Therapeutic Uses
Ketamine
Analgesics
Diabetes Complications
Excitatory Amino Acid Antagonists
Anesthetics, Intravenous

Sympatholytics
Adrenergic alpha-Agonists
Diabetic Neuropathies
Clonidine
Nervous System Diseases
Diabetes Mellitus
Endocrine System Diseases
Central Nervous System Depressants
Cardiovascular Agents
Antihypertensive Agents
Anesthetics, Dissociative
Pharmacologic Actions
Autonomic Agents
Anesthetics, General
Peripheral Nervous System Diseases

ClinicalTrials.gov processed this record on November 27, 2009