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Comparative study of efficacy and safety of ketamine, clonidine, mixture of both and placebo in patients with diabetic neuropathic pain
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| K | Experimental | drug - ketamine 1% gel |
|
| P | Placebo Comparator | vehicle gel |
|
| M | Experimental | association of ketamine and clonidine gel |
|
| C | Experimental | clonidine gel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ketamine | Drug | ketamine 150 mcg/g bid |
| |
| vehicle gel |
| Measure | Description | Time Frame |
|---|---|---|
| pain evaluation by visual analogue scale | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| pain evaluation by amount of rescue medication required | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Judymara L Gozzani, investigator | Contact | 55-11-3884-0865 | gozzani@osite.com.br |
| Name | Affiliation | Role |
|---|---|---|
| Judymara L Gozzani, Investigator | Santa Casa de São Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santa Casa de São Paulo | São Paulo | São Paulo | 01277-900 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35587172 | Derived | Serednicki WT, Wrzosek A, Woron J, Garlicki J, Dobrogowski J, Jakowicka-Wordliczek J, Wordliczek J, Zajaczkowska R. Topical clonidine for neuropathic pain in adults. Cochrane Database Syst Rev. 2022 May 19;5(5):CD010967. doi: 10.1002/14651858.CD010967.pub3. |
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| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| D010146 | Pain |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| D003000 | Clonidine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| Drug |
bid - 12 weeks |
|
| ketamine + clonidine | Drug | ketamine 150mcg/g + clonidine 1% gel bid 12 weeks |
|
| clonidine gel 1% | Drug | bid 12 weeks |
|
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D048288 | Imidazolines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |