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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00986180 | NUCYNTA (Tapentadol Immediate Release) Versus Oxycodone Immediate Release in the Treatment of Acute Low Back Pain | PHASE3 | COMPLETED | 667 | — | — | Sep 1, 2009 | Dec 1, 2010 | Dec 19, 2012 | 74 | United States |
Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 120 hours.
| Arm | Type | Description |
|---|---|---|
| 001 | EXPERIMENTAL | NUCYNTA 50 75 or 100 mg every 4 to 6 hours for up to 10 days as needed for pain |
| 002 | ACTIVE_COMPARATOR | Oxycodone IR 5 10 or 15 mg every 4 to 6 hours for up to 10 days as needed for pain |
| Name | Type | Description |
|---|---|---|
| NUCYNTA | DRUG | 50, 75, or 100 mg every 4 to 6 hours for up to 10 days as needed for pain |
| Oxycodone IR | DRUG | 5, 10, or 15 mg every 4 to 6 hours for up to 10 days as needed for pain |
Inclusion Criteria: * At Visit 1 (study entry) patients must have a medical history and physical and neurological examinations that support a clinical diagnosis of acute low back pain that is felt down to the lower leg below the knee with the onset no longer than 30 days before Visit 1 * At Visit 1...