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To compare the analgesic efficacy and safety of ABT-652 administered twice daily (BID) to placebo in subjects with osteoarthritis (OA) of the knee.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABT-652 high dose | Experimental | ABT-652 capsules- twice daily for 8 weeks. The dose of ABT-652 will depend on the Arm. |
|
| ABT-652 low dose | Experimental | ABT-652 capsules - twice daily for 8 weeks. The dose ABT-652 will depend on the Arm |
|
| Naproxen | Active Comparator | Naproxen capsules- twice daily for 8 weeks |
|
| Placebo | Placebo Comparator | Placebo capsules- twice daily for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-652 | Drug | ABT-652 capsules - twice daily for 8 weeks. The dose of ABT-652 will depend on the Arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| 24-hour average pain score measured by Visual Analog Scale | Subject reported pain intensity measured by Visual Analog Scale (0-100) | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Western Ontario and McMaster (WOMAC™ ) Osteoarthritis subscales, Pain, Physical Function and Stiffness scores | Self administered, patient-centered, health status questionnaire | 8 weeks |
| Subject's Global Assessment of Arthritis Status |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Rachel Duan, MD | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 37220 | Chandler | Arizona | 85224 | United States | ||
| Site Reference ID/Investigator# 37223 |
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| Placebo | Drug | Placebo capsules - twice daily for 8 weeks |
|
| Naproxen | Drug | Naproxen capsules - twice daily for 8 weeks |
|
Subject reported assessment of arthritis status measured by Visual Analogue Scale (0-100)
| 8 weeks |
| Brief Pain Inventory | Subject reported pain intensity and intereference (scale 0-10) | 8 weeks |
| SF-36v2™ Health Status Survey | There is no formal title for this quality of life survey, this is the only name for this measure. Subject reported quality of life survey | 8 weeks |
| Tempe |
| Arizona |
| 85282 |
| United States |
| Site Reference ID/Investigator# 37215 | Tucson | Arizona | 85704 | United States |
| Site Reference ID/Investigator# 37221 | Anaheim | California | 92801 | United States |
| Site Reference ID/Investigator# 37222 | Burbank | California | 91505 | United States |
| Site Reference ID/Investigator# 35956 | Chino | California | 91710 | United States |
| Site Reference ID/Investigator# 37053 | La Mesa | California | 91942 | United States |
| Site Reference ID/Investigator# 37218 | Lomita | California | 90717 | United States |
| Site Reference ID/Investigator# 37227 | Milford | Connecticut | 06460 | United States |
| Site Reference ID/Investigator# 37229 | Boynton Beach | Florida | 33472 | United States |
| Site Reference ID/Investigator# 37209 | Ocala | Florida | 34471 | United States |
| Site Reference ID/Investigator# 37212 | Plantation | Florida | 33317 | United States |
| Site Reference ID/Investigator# 35961 | South Miami | Florida | 33143 | United States |
| Site Reference ID/Investigator# 37207 | Valparaiso | Indiana | 46383 | United States |
| Site Reference ID/Investigator# 37217 | Brooklyn Center | Minnesota | 55430 | United States |
| Site Reference ID/Investigator# 37228 | St Louis | Missouri | 63141 | United States |
| Site Reference ID/Investigator# 35959 | New York | New York | 10004 | United States |
| Site Reference ID/Investigator# 37211 | Salisbury | North Carolina | 28144 | United States |
| Site Reference ID/Investigator# 37214 | Duncansville | Pennsylvania | 16635 | United States |
| Site Reference ID/Investigator# 37205 | Wyomissing | Pennsylvania | 19610 | United States |
| Site Reference ID/Investigator# 37208 | Austin | Texas | 78705 | United States |
| Site Reference ID/Investigator# 37213 | San Antonio | Texas | 78209-1744 | United States |
| Site Reference ID/Investigator# 35953 | Richmond | Virginia | 23294 | United States |
| Site Reference ID/Investigator# 41782 | Brisbane | 4102 | Australia |
| Site Reference ID/Investigator# 41779 | Campsie, Sydney | 2194 | Australia |
| Site Reference ID/Investigator# 41778 | Clayton | 3168 | Australia |
| Site Reference ID/Investigator# 41785 | Fitzroy | VIC 3065 | Australia |
| Site Reference ID/Investigator# 41582 | Kogarah | 2217 | Australia |
| Site Reference ID/Investigator# 41776 | Malvern East | 3145 | Australia |
| Site Reference ID/Investigator# 41563 | Montreal | H2L 1S6 | Canada |
| Site Reference ID/Investigator# 41566 | Newmarket | L3Y 3R7 | Canada |
| Site Reference ID/Investigator# 41565 | Pointe-Claire | H9J 3W3 | Canada |
| Site Reference ID/Investigator# 41562 | Sainte-Foy, Quebec | G1W 4R4 | Canada |
| Site Reference ID/Investigator# 41951 | Santiago | Chile |
| Site Reference ID/Investigator# 37183 | Caguas | 00725 | Puerto Rico |
| Site Reference ID/Investigator# 37622 | Ponce | 00716 | Puerto Rico |
| Site Reference ID/Investigator# 35966 | San Juan | 00936-8344 | Puerto Rico |
| Site Reference ID/Investigator# 37184 | Trujillo Alto | 00976 | Puerto Rico |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D009288 | Naproxen |
| ID | Term |
|---|---|
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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