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Diabetic Neuropathy Topical Treatment

The recruitment status of this study is unknown because the information has not been verified recently.
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
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Diabetic Neuropathic Pain Topical Treatment- Comparative Study

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ 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
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
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 Paulo
Investigators
Principal Investigator: Judymara L Gozzani, Investigator Santa Casa de São Paulo
  More Information

No publications provided

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
Health Authority: Brazil: National Health Surveillance Agency

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

Additional relevant MeSH terms:
Diabetic Neuropathies
Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Ketamine
Clonidine
Anesthetics, Dissociative
Anesthetics, Intravenous
 Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antihypertensive Agents

ClinicalTrials.gov processed this record on May 22, 2013