Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

Diabetic Neuropathy Topical Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
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

Layout table for study information
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

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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier (NCT number): NCT00661063

Layout table for location contacts
Contact: Judymara L Gozzani, investigator 55-11-3884-0865

Layout table for location information
Santa Casa de São Paulo
São Paulo, Brazil, 01277-900
Sponsors and Collaborators
Irmandade da Santa Casa de Misericordia de Sao Paulo
Layout table for investigator information
Principal Investigator: Judymara L Gozzani, Investigator Santa Casa de São Paulo
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Judymara Lauzi Gozzani PhD, ISCMSP Identifier: NCT00661063    
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetic Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents