Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01207115 | A Study of ABT-652 in Adults With Osteoarthritis Pain of the Knee | PHASE2 | COMPLETED | 322 | — | — | Sep 1, 2010 | May 1, 2011 | Jan 7, 2013 | 38 | United States, Australia +3 |
Subject reported pain intensity measured by Visual Analog Scale (0-100)
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| ABT-652 | DRUG | ABT-652 capsules - twice daily for 8 weeks. The dose of ABT-652 will depend on the Arm |
| Placebo | DRUG | Placebo capsules - twice daily for 8 weeks |
| Naproxen | DRUG | Naproxen capsules - twice daily for 8 weeks |
Inclusion Criteria * History of OA of the knee joint and meeting American College of Rheumatology (ACR) Clinical and Radiographic criteria, * Pain score as required by the protocol at Screening and Baseline * Willing to washout of analgesics and to follow treatment plan, visit schedules and study p...