Phase 2
Completed N=168
Phase 2 Chronic Low Back Pain Study
Source: ClinicalTrials.gov NCT01364922 ↗Enrolled (actual)
168
Serious AEs
0.3%
Results posted
Dec 2013
Primary outcomePrimary: Change From Double-blind Baseline in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS) — 10.9; 19.9 scores on a scale
Summary
The primary purpose of this study was to evaluate the analgesic effect and safety of hydrocodone/acetaminophen extended release compared to placebo.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Double-blind Baseline in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS) |
10.9; 19.9 | — |
| SECONDARY Participant's Global Assessment of Back Pain Status at Final Evaluation |
13; 2; 47; 16; 25; 19 | — |
| SECONDARY Participant's Global Assessment of Study Drug at Final Evaluation |
2; 7; 11; 4; 36; 19 | — |
Eligibility Criteria
Inclusion Criteria
Adult subjects who have a diagnosis of chronic low back pain of at least 6 month duration
Exclusion Criteria
Subjects with a history of surgical or invasive intervention
Data sourced from ClinicalTrials.gov (NCT01364922). 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.