Diabetic Neuropathy Topical Treatment - Full Text View

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

MedlinePlus related topics:

Diabetic Nerve Problems

ChemIDplus related topics:

Clonidine Phenylephrine Guaifenesin Naphazoline Naphazoline hydrochloride Oxymetazoline Oxymetazoline hydrochloride Phenylephrine hydrochloride Phenylpropanolamine Phenylpropanolamine hydrochloride Ketamine Ketamine hydrochloride Clonidine hydrochloride

U.S. FDA Resources

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

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	Not yet recruiting
	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

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

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

neuropathic pain

ketamine

clonidine

association

Study placed in the following topic categories:

Excitatory Amino Acids

Diabetic Neuropathies

Clonidine

Diabetes Mellitus

Endocrine System Diseases

Pain

Naphazoline

Oxymetazoline

Neuromuscular Diseases

Guaifenesin

Phenylephrine

Peripheral Nervous System Diseases

Ketamine

Endocrinopathy

Phenylpropanolamine

Diabetes Complications

Additional relevant MeSH terms:

Anesthetics, Intravenous

Sympatholytics

Neurotransmitter Agents

Adrenergic alpha-Agonists

Adrenergic Agents

Molecular Mechanisms of Pharmacological Action

Nervous System Diseases

Physiological Effects of Drugs

Anesthetics

Central Nervous System Depressants

Excitatory Amino Acid Agents

Cardiovascular Agents

Antihypertensive Agents

Adrenergic Agonists

Anesthetics, Dissociative

Pharmacologic Actions

Autonomic Agents

Sensory System Agents

Anesthetics, General

Therapeutic Uses

Peripheral Nervous System Agents

Analgesics

Central Nervous System Agents

Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	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