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ThermoProfen is a transdermal ketoprofen patch that is integrated with a long-lasting CHADD (Controlled Heat-Assisted Drug Delivery) unit for the treatment of chronic pain associated with osteoarthritis. This study will evaluate ThermoProfen for the treatment of mild to moderate pain associated with osteoarthritis of the knee in adults.
The primary objective of the study is to compare the efficacy of ThermoProfenâ„¢ against two other experimental treatments.
The treatment may be ThermoProfen (Matrix Transdermal Ketoprofen Patch) or a patch that may or may not include ketoprofen and that may or may not provide heat.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thermoprofen | Experimental | ThermoProfenâ„¢ (ketoprofen matrix/Controlled Heat Assisted Drug Delivery [CHADDâ„¢] patch) |
|
| Placebo Matrix | Placebo Comparator | Placebo matrix with CHADD patch. |
|
| Ketoprofen matrix/placebo CHADD | Placebo Comparator | Ketoprofen matrix with placebo CHADD patch (no heat) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ThermoProfenâ„¢ (Matrix Transdermal Ketoprofen/CHADDâ„¢ System) | Drug | Transdermal patch applied to the knee for 12 hours daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome measure is the change from baseline in the Visual Analog Scale score for the average pain during the previous 24 hours. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Visual Analog Scale score for worst pain during the previous 24 hours, amount of rescue medication used to treat the target joint per day, and the patient global impression of change in the Likert Scale | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | ZARS Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peoria | Arizona | 85381 | United States | |||
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| Placebo Matrix/CHADD Patch | Drug | Transdermal patch applied to the knee for 12 hours daily. |
|
|
| Ketoprofen matrix/placebo CHADD Patch | Drug | Transdermal knee applied to the knee for 12 hours daily. |
|
|
| Anaheim |
| California |
| 92801 |
| United States |
| Buena Park | California | 90620 | United States |
| San Diego | California | 92103 | United States |
| Westlake Village | California | 91361 | United States |
| Hamden | Connecticut | 06518 | United States |
| Milford | Connecticut | 06460 | United States |
| Clearwater | Florida | 33761 | United States |
| Jupiter | Florida | 33458 | United States |
| Pembroke Pines | Florida | 33024 | United States |
| South Miami | Florida | 33143 | United States |
| Tampa | Florida | 33614 | United States |
| Boise | Idaho | 83704 | United States |
| Springfield | Illinois | 62704 | United States |
| Evansville | Indiana | 47714 | United States |
| Overland Park | Kansas | 66215 | United States |
| Baltimore | Maryland | 21239 | United States |
| Wheaton | Maryland | 20902 | United States |
| Lansing | Michigan | 48910 | United States |
| Kansas City | Missouri | 64114 | United States |
| Mercerville | New Jersey | 08619 | United States |
| Greensboro | North Carolina | 27408 | United States |
| Raleigh | North Carolina | 27612 | United States |
| Lake Oswego | Oregon | 97035 | United States |
| Portland | Oregon | 97239 | United States |
| Duncansville | Pennsylvania | 16635 | United States |
| Erie | Pennsylvania | 16508 | United States |
| Mechanicsburg | Pennsylvania | 17055 | United States |
| Anderson | South Carolina | 29621 | United States |
| Myrtle Beach | South Carolina | 29572 | United States |
| Nashville | Tennessee | 37205 | United States |
| Houston | Texas | 77090 | United States |
| San Antonio | Texas | 78217 | United States |
| Salt Lake City | Utah | 84106 | United States |
| Spokane | Washington | 99204 | United States |
| Tacoma | Washington | 98405 | United States |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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