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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00771758 | Tapentadol IR vs Oxycodone IR vs Placebo in Acute Pain From Vertebral Compression Fracture Associated With Osteoporosis | PHASE3 | COMPLETED | 108 | — | — | Sep 1, 2008 | Dec 1, 2009 | May 9, 2014 | 37 | United States |
Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID72 was calculated as the time-weighted Sum of PID scores over 72 hours. The range of SPID72 is from -720 to 720. The higher value in SPID indicates greater pain relief. The study was terminated prematurely due to slow enrollment after 108 of 600 subjects enrolled. Valid statistical conclusions cannot be made due to the low number of subjects.
| Arm | Type | Description |
|---|---|---|
| 001 | EXPERIMENTAL | tapentadol IR 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days maximum daily dose 450 mg |
| 002 | EXPERIMENTAL | oxycodone IR 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days maximum daily dose 60 mg |
| 003 | PLACEBO_COMPARATOR | placebo 1 capsule every 4 - 6 hr as needed for up to 10 days |
| Name | Type | Description |
|---|---|---|
| oxycodone IR | DRUG | maximum daily dose 450 mg |
| placebo | DRUG | 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days |
| tapentadol IR | DRUG | 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days |
Inclusion Criteria: * Female (non-pregnant, non-lactating) and male * new onset of pain or acute exacerbation of previous pain associated with a VCF within 14 days prior to Visit 1 * Radiographic confirmation of a VCF within 3 months prior to Visit 1 or a radiographic procedure performed at Visit 1...