Phase 3
Completed N=285
Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP)
Source: ClinicalTrials.gov NCT00763321 ↗Enrolled (actual)
285
Serious AEs
0.6%
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) — 1.2; 23.0 scores on a scale
Summary
The primary purpose of the study is 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) |
1.2; 23.0 | — |
| SECONDARY Change From Double-blind (DB) Baseline to Final Assessment in Chronic Pain Sleep Inventory (CPSI) |
-3.7; 18.7; -1.2; 13.5; -5.0; 19.5 | — |
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 (NCT00763321). 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.