Phase 2 N=168 Randomized Double-blind Treatment

Phase 2 Chronic Low Back Pain Study

Chronic Low Back Pain

Bottom Line

View on ClinicalTrials.gov: NCT01364922 ↗

Enrolled (actual)

168

Serious AEs

0.3%

Results posted

Dec 2013

Primary outcome: Primary: 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

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: hydrocodone/acetaminophen extended release (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: AbbVie (prior sponsor, Abbott)
Primary completion: Oct 2011

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	—

Summary

The primary purpose of this study was to evaluate the analgesic effect and safety of hydrocodone/acetaminophen extended release compared to placebo.

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

View full record on ClinicalTrials.gov →

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.