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| Sponsor: | 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Judymara L Gozzani, investigator | 55-11-3884-0865 | gozzani@osite.com.br |
| Brazil | |
| Santa Casa de São Paulo | |
| São Paulo, Brazil, 01277-900 | |
| 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 |
| Study First Received: | April 15, 2008 |
| Last Updated: | April 17, 2008 |
| ClinicalTrials.gov Identifier: | NCT00661063 History of Changes |
| Health Authority: | Brazil: National Health Surveillance Agency |
|
neuropathic pain ketamine clonidine association |
|
Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anesthetics Excitatory Amino Acid Agents Adrenergic Agonists Neuromuscular Diseases Sensory System Agents Therapeutic Uses Ketamine Analgesics Diabetes Complications Excitatory Amino Acid Antagonists Anesthetics, Intravenous |
Sympatholytics Adrenergic alpha-Agonists Diabetic Neuropathies Clonidine Nervous System Diseases Diabetes Mellitus Endocrine System Diseases Central Nervous System Depressants Cardiovascular Agents Antihypertensive Agents Anesthetics, Dissociative Pharmacologic Actions Autonomic Agents Anesthetics, General Peripheral Nervous System Diseases |