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Diabetic Neuropathy Topical Treatment

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ClinicalTrials.gov Identifier: NCT00661063
Recruitment Status : Unknown
Verified April 2008 by Irmandade da Santa Casa de Misericordia de Sao Paulo.
Recruitment status was:  Not yet recruiting
First Posted : April 18, 2008
Last Update Posted : April 18, 2008
Sponsor:
Information provided by:
Irmandade da Santa Casa de Misericordia de Sao Paulo

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

Condition or disease Intervention/treatment Phase
Diabetic Neuropathy Pain Drug: ketamine Drug: vehicle gel Drug: ketamine + clonidine Drug: clonidine gel 1% Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Diabetic Neuropathic Pain Topical Treatment- Comparative Study
Study Start Date : April 2008
Estimated Primary Completion Date : April 2009
Estimated Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. pain evaluation by visual analogue scale [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. pain evaluation by amount of rescue medication required [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Judymara Lauzi Gozzani PhD, ISCMSP
ClinicalTrials.gov Identifier: NCT00661063     History of Changes
Other Study ID Numbers: 042/2007
First Posted: April 18, 2008    Key Record Dates
Last Update Posted: April 18, 2008
Last Verified: April 2008

Keywords provided by Irmandade da Santa Casa de Misericordia de Sao Paulo:
neuropathic pain
ketamine
clonidine
association

Additional relevant MeSH terms:
Diabetic Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Ketamine
Clonidine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents