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To evaluate the safety and efficacy of ABT-652 in combination with a Non-steroidal Anti-inflammatory Drug (NSAID) compared to NSAID alone in adults with osteoarthritis (OA) of the knee.
This is a randomized withdrawal design study, containing a 4 week open-label period followed by a 6 week double-blind period. The total treatment period will be 10 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABT-652 NSAID | Experimental | ABT-652 capsules -2 ABT-652 capsules twice daily (add-on) NSAID - as prescribed |
|
| Placebo NSAID | Placebo Comparator | Placebo - 2 placebo capsules twice daily NSAID - as prescribed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-652 NSAID | Drug | ABT-652 capsules - 2 ABT-652 capsules twice daily (add-on) NSAID- as prescribed |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subject's Assessment of Arthritis Pain Intensity | Subject reported 24-hour average pain score measured by Visual Analogue Scale | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Western Ontario and McMaster (WOMACâ„¢ ) Osteoarthritis Index | Self administered, patient-centered, health status questionnaire | 6 weeks |
| Subject's Global Assessment of Arthritis Status | Subject reported pain intensity measured by Visual Analog Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wolfram Nothaft, MD | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 61226 | Phoenix | Arizona | 85023 | United States | ||
| Site Reference ID/Investigator# 61221 |
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| Placebo NSAID | Drug | Placebo - 2 placebo capsules twice daily NSAID- as prescribed |
|
| 6 weeks |
| Cognitive Functioning in Patients with Chronic Pain | Subject reported assessment of cognitive functioning | 6 weeks |
| Phoenix |
| Arizona |
| 85032 |
| United States |
| Site Reference ID/Investigator# 61241 | Tucson | Arizona | 85704 | United States |
| Site Reference ID/Investigator# 61257 | Anaheim | California | 92801 | United States |
| Site Reference ID/Investigator# 61246 | Fresno | California | 93726 | United States |
| Site Reference ID/Investigator# 61242 | La Mesa | California | 91942 | United States |
| Site Reference ID/Investigator# 61204 | Long Beach | California | 90806 | United States |
| Site Reference ID/Investigator# 61258 | North Hollywood | California | 91606 | United States |
| Site Reference ID/Investigator# 61265 | Milford | Connecticut | 06460 | United States |
| Site Reference ID/Investigator# 61234 | DeLand | Florida | 32720 | United States |
| Site Reference ID/Investigator# 61213 | Ocala | Florida | 34471 | United States |
| Site Reference ID/Investigator# 61211 | Oldsmar | Florida | 34677 | United States |
| Site Reference ID/Investigator# 61217 | Orlando | Florida | 32806 | United States |
| Site Reference ID/Investigator# 61231 | Plantation | Florida | 33317 | United States |
| Site Reference ID/Investigator# 61245 | Tampa | Florida | 33603 | United States |
| Site Reference ID/Investigator# 61263 | Marietta | Georgia | 30060 | United States |
| Site Reference ID/Investigator# 61210 | Brockton | Massachusetts | 02301 | United States |
| Site Reference ID/Investigator# 61260 | Watertown | Massachusetts | 02472-3930 | United States |
| Site Reference ID/Investigator# 61244 | Florissant | Missouri | 63031 | United States |
| Site Reference ID/Investigator# 61266 | St Louis | Missouri | 63141 | United States |
| Site Reference ID/Investigator# 61206 | Omaha | Nebraska | 68134 | United States |
| Site Reference ID/Investigator# 61223 | Salisbury | North Carolina | 28144 | United States |
| Site Reference ID/Investigator# 61273 | Cincinnati | Ohio | 45245 | United States |
| Site Reference ID/Investigator# 61228 | Oklahoma City | Oklahoma | 73109 | United States |
| Site Reference ID/Investigator# 61264 | Portland | Oregon | 97239 | United States |
| Site Reference ID/Investigator# 61238 | Duncansville | Pennsylvania | 16635 | United States |
| Site Reference ID/Investigator# 61205 | Beaumont | Texas | 77701 | United States |
| Site Reference ID/Investigator# 61218 | Bryan | Texas | 77802 | United States |
| Site Reference ID/Investigator# 61235 | San Antonio | Texas | 78209 | United States |
| Site Reference ID/Investigator# 61232 | Draper | Utah | 84020 | United States |
| Site Reference ID/Investigator# 61269 | Franklin | Wisconsin | 53132 | United States |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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