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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00761150 | Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP) | PHASE3 | COMPLETED | 308 | — | — | Sep 1, 2008 | Mar 1, 2009 | Feb 7, 2014 | 32 | United States |
| NCT00763321 | Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP) | PHASE3 | COMPLETED | 287 | — | — | Sep 1, 2008 | Apr 1, 2009 | Feb 6, 2014 | 31 | United States |
The change from the DB randomization baseline (DB baseline: the last assessment before first dose in the DB period) to the final assessment in pain intensity, assessed using the CLBP Intensity VAS (0 mm = No Pain and 100 mm = Worst Pain Imaginable). Least squares means and standard errors from 2-way ANCOVA model without interaction.
| Arm | Type | Description |
|---|---|---|
| Open-label ABT-712 | EXPERIMENTAL | 2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks (open-label period). |
| Double-blind ABT-712 | EXPERIMENTAL | 2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period). |
| Double-blind Placebo | PLACEBO_COMPARATOR | 2 placebo tablets, twice daily, for 4 weeks (double-blind period). |
| Name | Type | Description |
|---|---|---|
| ABT-712 | DRUG | ABT-712 extended-release tablet |
| Placebo | DRUG | Placebo tablet |
Inclusion Criteria: * Adult male and female subjects who voluntarily sign the informed consent * Diagnosis of CLBP of 6 months duration Exclusion Criteria: * Incapacitated or bedridden subjects * Subjects with history of surgical or invasive intervention