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The purpose of this study is to evaluate the safety and tolerability of Egalet-002 in opioid-experienced patients with moderate-to-severe chronic noncancer pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxycodone extended-release | Experimental | Egalet abuse-deterrent, extended-release oxycodone tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxycodone extended-release | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of TEAEs during the Open-label Treatment Period, including those leading to treatment withdrawal, and/or abnormal physical examination findings, vital signs measurements, ECGs, and clinical laboratory test results, related to treatment | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Findings of the Brief Pain Inventory-Short Form (BPI-SF) during the Open-label Treatment Period | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 334 | Huntsville | Alabama | 35801 | United States | ||
| Site 328 |
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| Tucson |
| Arizona |
| 85712 |
| United States |
| Site 332 | Jacksonville | Florida | 32257 | United States |
| Site 340 | Miami Gardens | Florida | 33169 | United States |
| Site 320 | Plantation | Florida | 33317 | United States |
| Site 302 | Tampa | Florida | 33603 | United States |
| Site 315 | Tampa | Florida | 33613 | United States |
| Site 310 | Winter Haven | Florida | 33880 | United States |
| Site 316 | Dawsonville | Georgia | 30534 | United States |
| Site 311 | Marietta | Georgia | 30060 | United States |
| Site 336 | Bloomington | Illinois | 61701 | United States |
| Site 345 | Blue Island | Illinois | 60406 | United States |
| Site 304 | Evansville | Indiana | 47714 | United States |
| Site 325 | Valparaiso | Indiana | 46383 | United States |
| Site 321 | Overland Park | Kansas | 66210 | United States |
| Site 342 | Wichita | Kansas | 67205 | United States |
| Site 329 | New Orleans | Louisiana | 70114 | United States |
| Site 326 | Quincy | Massachusetts | 02169 | United States |
| Site 303 | St Louis | Missouri | 63141 | United States |
| Site 306 | Las Vegas | Nevada | 89119 | United States |
| Site 313 | Belvidere | New Jersey | 07823 | United States |
| Site 346 | Blackwood | New Jersey | 08012 | United States |
| Site 323 | Hartsdale | New York | 10530 | United States |
| Site 338 | Mooresville | North Carolina | 28117 | United States |
| Site 333 | Cincinnati | Ohio | 45212 | United States |
| Site 343 | Cleveland | Ohio | 44122 | United States |
| Site 308 | Huber Heights | Ohio | 45424 | United States |
| Site 347 | Kettering | Ohio | 45429 | United States |
| Site 335 | Oklahoma City | Oklahoma | 73112 | United States |
| Site 312 | Eugene | Oregon | 97401 | United States |
| Site 322 | Duncansville | Pennsylvania | 16635 | United States |
| Site 324 | Wyomissing | Pennsylvania | 19610 | United States |
| Site 344 | Myrtle Beach | South Carolina | 29588 | United States |
| Site 314 | Summerville | South Carolina | 29485 | United States |
| Site 341 | New Tazewell | Tennessee | 37825 | United States |
| Site 318 | Austin | Texas | 78731 | United States |
| Site 330 | Dallas | Texas | 75231 | United States |
| Site 309 | San Antonio | Texas | 78218 | United States |
| Site 331 | West Jordan | Utah | 84088 | United States |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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