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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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This study will evaluate the efficacy and safety of Bupivacaine TTS (Bupivacaine patch) compared to placebo in patients with chronic low back pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivacaine TTS | Experimental |
| |
| Placebo patch | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine TTS (Bupivacaine Patch) | Drug | Contains bupivacaine base, in a flexible and rectangular-shaped, transdermal, delivery system. Three patches applied to the lower back every 72 hours for 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline to 12 weeks in pain in the last 24 hours (daily scores averaged over 14 days) | baseline to 12 weeks after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Subjects achieving 20% pain relief at 12 weeks compared to baseline | baseline to 12 weeks after baseline | |
| Subjects 'much improved' or 'very much improved' at 12 weeks | 12 weeks after baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Meisner, PharmD | King Pharmaceuticals is now a wholly owned subsidiary of Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tempe | Arizona | 85283 | United States | |||
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| Placebo patch | Drug | Identical in size and shape to the Bupivacaine Patch. Three patches applied to the lower back every 72 hours for 12 weeks. |
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| La Mesa |
| California |
| 91942 |
| United States |
| Torrance | California | 90502 | United States |
| Fort Lauderdale | Florida | 33306 | United States |
| Gainesville | Florida | 32605 | United States |
| Longwood | Florida | 32779 | United States |
| West Palm Beach | Florida | 33409 | United States |
| Marietta | Georgia | 30060 | United States |
| Newnan | Georgia | 30265 | United States |
| Springfield | Massachusetts | 01103 | United States |
| St Louis | Missouri | 63141 | United States |
| New York | New York | 10004 | United States |
| Winston-Salem | North Carolina | 27103 | United States |
| Oklahoma City | Oklahoma | 73109 | United States |
| Allentown | Pennsylvania | 18103 | United States |
| Altoona | Pennsylvania | 16602 | United States |
| Philadelphia | Pennsylvania | 19139 | United States |
| Austin | Texas | 78756 | United States |
| Dallas | Texas | 75231 | United States |
| Houston | Texas | 77074 | United States |
| Richmond | Virginia | 23294 | United States |