Phase 3
Completed N=308
Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP)
Source: ClinicalTrials.gov NCT00761150 ↗Enrolled (actual)
308
Serious AEs
0.5%
Results posted
Dec 2013
Primary outcomePrimary: Change From Double-blind (DB) Baseline to Final Assessment in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS) — 1.1; 18.0 scores on a scale
Summary
The primary purpose of the study was to test the efficacy of 2 tablets (twice daily) of ABT-712, compared to placebo, administered over a 4-week period in participants with moderate to severe mechanical chronic low back pain (CLBP).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Double-blind (DB) Baseline to Final Assessment in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS) |
1.1; 18.0 | — |
| SECONDARY Change From Double-blind (DB) Baseline to Final Assessment in Chronic Pain Sleep Inventory (CPSI) |
-4.8; 13.1; -1.6; 8.4; -0.5; 15.1 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00761150). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.