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The purpose of this study is to evaluate the efficacy and safety of SLC022 in treating pain associated with post-herpetic neuralgia (PHN) in recently diagnosed patients.
This study will enroll subjects with established PHN, a stable pain intensity and that meet all other eligibility criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SLC022 | Experimental | 300mg TID |
|
| Placebo | Placebo Comparator | Matching placebo capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SLC022 | Drug | SLC022 150 mg capsule, 900mg daily dose |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint of this study is the change in a subject's mean pain score from the baseline period to the end of the treatment period as measured using the 11-point Numerical Rating Scale. | 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Determining the safety and tolerability of SLC022 300 mg TID compared to placebo TID in subjects with PHN by measuring changes in vital signs, ECG, hematology and other laboratory values, and subject-reported adverse events. | 7 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Pojasek, PhD | Solace Pharmaceuticals Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sierra Vista | Arizona | 85635 | United States | |||
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| Drug |
Placebo capsule, TID |
|
| Mission Viejo |
| California |
| 92691 |
| United States |
| Orlando | Florida | 32806 | United States |
| Plantation | Florida | 33324 | United States |
| Marietta | Georgia | 30060 | United States |
| Oak Brook | Illinois | 60523 | United States |
| Shreveport | Louisiana | 71030 | United States |
| Brockton | Massachusetts | 20301 | United States |
| Omaha | Nebraska | 68134 | United States |
| Rochester | New York | 14618 | United States |
| Winston-Salem | North Carolina | 27103 | United States |
| Kettering | Ohio | 45429 | United States |
| Altoona | Pennsylvania | 16602 | United States |
| Philadelphia | Pennsylvania | 19139 | United States |
| West Reading | Pennsylvania | 19611 | United States |
| Dallas | Texas | 75230 | United States |
| Houston | Texas | 77074 | United States |
| San Antonio | Texas | 78229 | United States |
| Midvale | Utah | 84047 | 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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