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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01571362 | A Research Study of an Investigational Drug ALO-02 (Oxycodone Hydrochloride and Naltrexone Hydrochloride) in Patients With Moderate to Severe Chronic Low Back Pain | PHASE3 | COMPLETED | 410 | — | — | Jun 1, 2012 | Jun 1, 2013 | Apr 4, 2017 | 52 | United States |
Weekly average diary NRS-Pain scores were derived from the daily NRS-pain scale and calculated as the mean of the last 7 days. NRS-Pain scores based on an 11-point numerical rating scale from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain.
| Arm | Type | Description |
|---|---|---|
| ALO-02 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| ALO-02 | DRUG | 20 to 160mg total daily dose of oxycodone, divided into symmetric doses and administered twice daily |
| Placebo | DRUG | oral placebo, divided into symmetric doses and administered twice daily |
Inclusion Criteria: * Moderate-to-severe chronic low back pain present for at least 3 months. * Require a continuous around-the-clock opioid analgesic for an extended period of time. * Refrain from taking other opioid and non-opioid medications during the study. Exclusion Criteria: * Active or wi...