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This study is an open-label multi-center to evaluate the tolerability of treatment with NGX-4010 use with pre-patch topical application of a topical anesthetic cream. This is an open-label study. No hypothesis testing will be performed.
Eligible subjects will have PHN and a level of pain at an intensity level deemed appropriate for open-label treatment with NGX-4010, as judged by the Investigator. Painful areas of up to a maximum of 1000 cm2 will be pre-treated with lidocaine (2.5%)/prilocaine (2.5%) cream for 60 minutes followed by a single, 60-minute application of NGX-4010. Subjects may be on chronic pain medication regimens, but currently will not be using any topical pain medications on the affected areas, such as non-steroidal anti-inflammatory drugs, menthol, methyl salicylate, local anesthetics including Lidoderm® (lidocaine patch 5%), steroids or capsaicin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NGX-4010 patch | Experimental |
| |
| Lidocaine (2.5%)/Prilocaine (2.5%) Cream | Experimental | Pre-treatment for NGX-4010 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| capsaicin 8% | Drug | High concentration capsaicin 8% dermal patch applied for one hour |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of patch application | Day of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in NPRS scores from pre-treatment values to subsequent time points on the day of treatment | Day of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anchor Research Center | Naples | Florida | 34102 | United States | ||
| Comprehensive NeuroScience, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22182397 | Derived | Webster LR, Nunez M, Tark MD, Dunteman ED, Lu B, Tobias JK, Vanhove GF. Tolerability of NGX-4010, a capsaicin 8% dermal patch, following pretreatment with lidocaine 2.5%/prilocaine 2.5% cream in patients with post-herpetic neuralgia. BMC Anesthesiol. 2011 Dec 19;11:25. doi: 10.1186/1471-2253-11-25. |
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| Lidocaine (2.5%)/Prilocaine (2.5%) Cream |
| Drug |
Pre-treatment for NGX-4010 |
|
| St. Petersburg |
| Florida |
| 33702 |
| United States |
| Drug Studies America | Marietta | Georgia | 30060 | United States |
| A & A Pain Institute | St Louis | Missouri | 63141 | United States |
| Clinical Trials of America, Inc. | Hickory | North Carolina | 28601 | United States |
| Lifetree Clinical Research | Salt Lake City | Utah | 84106 | United States |
| ID | Term |
|---|---|
| D051474 | Neuralgia, Postherpetic |
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002211 | Capsaicin |
| D008012 | Lidocaine |
| D011318 | Prilocaine |
| ID | Term |
|---|---|
| D053284 | Polyunsaturated Alkamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D005229 | Fatty Acids, Monounsaturated |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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