Diabetic Neuropathy Topical Treatment

The recruitment status of this study is unknown because the information has not been verified recently.

Verified April 2008 by Irmandade da Santa Casa de Misericordia de Sao Paulo. Recruitment status was Not yet recruiting

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

Sponsor:	Irmandade da Santa Casa de Misericordia de Sao Paulo
Information provided by:	Irmandade da Santa Casa de Misericordia de Sao Paulo
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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Diabetic Neuropathic Pain Topical Treatment- Comparative Study

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

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 Paulo:

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
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

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	Not yet recruiting
São Paulo, Brazil, 01277-900

Sponsors and Collaborators

Irmandade da Santa Casa de Misericordia de Sao Paulo

Investigators

Principal Investigator:

Judymara L Gozzani, Investigator

Santa Casa de São Paulo

More Information

No publications provided

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

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

neuropathic pain
ketamine
clonidine
association

Additional relevant MeSH terms:

Diabetic Neuropathies
Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Ketamine
Clonidine
Anesthetics, Dissociative
Anesthetics, Intravenous

Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antihypertensive Agents

ClinicalTrials.gov processed this record on February 13, 2012