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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

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
  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




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