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Diabetic Neuropathy Topical Treatment

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2008 by Irmandade da Santa Casa de Misericordia de Sao Paulo.
Recruitment status was:  Not yet recruiting
Sponsor:
Information provided by:
Irmandade da Santa Casa de Misericordia de Sao Paulo
ClinicalTrials.gov Identifier:
NCT00661063
First received: April 15, 2008
Last updated: April 17, 2008
Last verified: April 2008
  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 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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 ]

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

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   (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
  Contacts and Locations
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, see Learn About Clinical Studies.

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

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

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

ClinicalTrials.gov processed this record on September 21, 2017