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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00979953 | Efficacy and Safety Study Evaluating ADL5859 and ADL5747 in Participants With Pain Due to Osteoarthritis of the Knee | PHASE2 | COMPLETED | 408 | — | — | Oct 1, 2009 | Jun 1, 2010 | Aug 14, 2015 | 11 | United States |
The mean of the daily average scores were calculated from the NPRS pain assessment for the previous 24 hours obtained once a day for at least 4 days from Day -6 through Day 1 (Baseline assessment) and everyday from Day 2 through Day 15 (Treatment Phase assessment). The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain.
| Arm | Type | Description |
|---|---|---|
| ADL5859 | EXPERIMENTAL | One 50-milligrams (mg) ADL5859 capsule, one 100-mg ADL5859 capsule, and 2 placebo capsules administered orally twice daily (BID) for 14 days |
| ADL5747 | EXPERIMENTAL | One 150-mg ADL5747 capsule and 3 placebo capsules administered orally BID for 14 days |
| Oxycodone CR | ACTIVE_COMPARATOR | One 10-mg Oxycodone controlled release (CR) capsule and 3 placebo capsules administered orally BID Days 1 through 4 One 20-mg Oxycodone CR capsule and 3 placebo capsules administered orally BID Days 5 through 14 |
| Placebo | PLACEBO_COMPARATOR | Four placebo capsules administered orally BID for 14 days |
| Name | Type | Description |
|---|---|---|
| ADL5859 | DRUG | - |
| ADL5747 | DRUG | - |
| Oxycodone CR | DRUG | - |
| Placebo | DRUG | - |
Key Inclusion Criteria: * a man or woman between 18 and 75 years of age, inclusive * for women of childbearing potential, be using an insertable, injectable, transdermal, or combination oral contraceptive deemed highly effective by the United States Food and Drug Administration from the first dose ...