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This study will compare Z160 and placebo in patients with Postherpetic Neuralgia for safety and efficacy for a period of 6 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Z160 | Experimental | 375 mg BID |
|
| Placebo | Placebo Comparator | matching placebo control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Z160 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to Week 6 in the weekly average pain score based on Pain Intensity-Numeric Rating Scale (PI-NRS) | Baseline to Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in weekly average pain score | Baseline to Weeks 1, 2, 3, 4, 5, 6 | |
| Neuropathic Pain Scale (NPS) | Baseline to Weeks 1, 2, 4, 6 | |
| Patient Global Impression of Change (PGIC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site | Birmingham | Alabama | 35216 | United States | ||
| Investigative Site |
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|
| Baseline to Week 6 |
| Profile of Mood States (POMS) | Baseline to Weeks 1, 2, 4, 6 |
| Daily Sleep Interference Scale (DSIS) | Baseline to Weeks 1, 2, 3, 4, 5, 6 |
| Short Form 36 (SF-36) | Baseline to Week 6 |
| Z160 plasma concentrations | Baseline to Weeks 1, 2, 4, 6 |
| Time to a >= 30% reduction in weekly average pain score | Baseline to Weeks 1, 2, 3, 4, 5, 6 |
| Time to a >= 50% reduction in weekly average pain score | Baseline to Weeks 1, 2, 3, 4, 5, 6 |
| Subjects who have >= 30% reduction in average daily pain score | Baseline to Week 6 |
| Subjects who have >= 50% reduction in average daily pain score | Baseline to Week 6 |
| Safety and tolerability | As measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events | Baseline to Weeks 1- 12 |
| Amount of rescue medication used | Baseline to Weeks 1, 2, 4 and 6 |
| Chandler |
| Arizona |
| 85224 |
| United States |
| Investigative Site | Mesa | Arizona | 85213 | United States |
| Investigative Site | Peoria | Arizona | 85381 | United States |
| Investigative Site | Phoenix | Arizona | 85020 | United States |
| Investigative Site | Scottsdale | Arizona | 85251 | United States |
| Investigative Site | Little Rock | Arkansas | 72205 | United States |
| Investigative Site | Irvine | California | 92618 | United States |
| Investigative Site | Los Angeles | California | 90033 | United States |
| Investigative Site | San Francisco | California | 94109 | United States |
| Investigative Site | Thousand Oaks | California | 91360 | United States |
| Investigative Site | Boulder | Colorado | 80304 | United States |
| Investigative Site | Colorado Springs | Colorado | 80920 | United States |
| Investigative Site | Denver | Colorado | 80218 | United States |
| Investigative Site | Brooksville | Florida | 34601 | United States |
| Investigative Site | Clearwater | Florida | 33756 | United States |
| Investigative Site | Miami | Florida | 33015 | United States |
| Investigative Site | Orlando | Florida | 32806 | United States |
| Investigative Site | Port Orange | Florida | 32127 | United States |
| Investigative Site | Royal Palm Beach | Florida | 33411 | United States |
| Investigative Site | Sarasota | Florida | 34243 | United States |
| Investigative Site | Tampa | Florida | 33606 | United States |
| Investigative Site | Chicago | Illinois | 60602 | United States |
| Investigative Site | Evansville | Indiana | 47714 | United States |
| Investigative Site | Shreveport | Louisiana | 71105 | United States |
| Investigative Site | Columbia | Maryland | 21045 | United States |
| Investigative Site | Boston | Massachusetts | 02131 | United States |
| Investigative Site | Ann Arbor | Michigan | 48104 | United States |
| Investigative Site | Bay City | Michigan | 48706 | United States |
| Investigative Site | Ocean Springs | Mississippi | 39564 | United States |
| Investigative Site | Hazelwood | Missouri | 63031 | United States |
| Investigative Site | Kansas City | Missouri | 64114 | United States |
| Investigative Site | St Louis | Missouri | 63117 | United States |
| Investigative Site | Omaha | Nebraska | 68124 | United States |
| Investigative Site | Toms River | New Jersey | 08755 | United States |
| Investigative Site | Albuquerque | New Mexico | 87102 | United States |
| Investigative Site | Brooklyn | New York | 11235 | United States |
| Investigative Site | New York | New York | 10016 | United States |
| Investigative Site | Greensboro | North Carolina | 27410 | United States |
| Investigative Site | Beavercreek | Ohio | 45432 | United States |
| Investigative Site | Columbus | Ohio | 43214 | United States |
| Investigative Site | Kettering | Ohio | 45429 | United States |
| Investigative Site | Oklahoma City | Oklahoma | 73112 | United States |
| Investigative Site | Charleston | South Carolina | 29407 | United States |
| Investigative Site | Nashville | Tennessee | 37205 | United States |
| Investigative Site | Tullahoma | Tennessee | 37388 | United States |
| Investigative Site | Austin | Texas | 78731 | United States |
| Investigative Site | Richardson | Texas | 75080 | United States |
| Investigative Site | Murray | Utah | 84123 | United States |
| Investigative Site | Salt Lake City | Utah | 84106 | United States |
| Investigative Site | Herndon | Virginia | 20171 | United States |
| Investigative Site | Bellevue | Washington | 98007 | United States |
| Investigative Site | Tacoma | Washington | 98405 | 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 |
|---|---|
| C000629484 | Z160 |
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