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Patient-reported health-related quality of life, work productivity, and activity impairment during treatment with ALO-02 (extended-release oxycodone and sequestered naltrexone) for moderate-to-severe chronic low back pain.
- Source :
-
Health & Quality of Life Outcomes . 10/17/2017, Vol. 15, p1-7. 7p. - Publication Year :
- 2017
-
Abstract
- <bold>Background: </bold>The efficacy of ALO-02, an abuse-deterrent formulation containing extended-release oxycodone and sequestered naltrexone, in the treatment of chronic low back pain (CLBP) was studied in a 12-week randomized controlled trial. Primary efficacy endpoint results have been published previously (Rauck et al., 2015). The current paper focuses on patient-reported outcomes for health-related quality of life (HRQL), work productivity, and activity impairment that were assessed during this study.<bold>Methods: </bold>This was a double-blind, placebo-controlled, randomized withdrawal study in patients with moderate-to-severe CLBP. After a screening period (≤2 weeks), patients entered an open-label titration period (4-6 weeks). Treatment responders were then randomized to a double-blind placebo-controlled treatment period (12 weeks). HRQL was assessed using changes in the Short Form-36 v2 Health Survey (SF-36v2) and the EuroQol-5 Dimensions Health Questionnaire 3-Level version (EQ-5D-3L). Work productivity and regular activities were evaluated using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP).<bold>Results: </bold>A total of 410 patients received ALO-02 during the open-label titration period, of which 280 (intent-to-treat (ITT) population) were treated during the double-blind placebo-controlled treatment period (placebo, n = 134; ALO-02, n = 146). Significant improvement was observed for all SF-36v2 subscales and component scores (p < 0.005) and the EQ-5D-3L summary index and visual analog scale (p < 0.0001) during the titration period. Improvement was also significant (p < 0.0001) for all WPAI:SHP outcomes except 'work time missed due to CLBP' for the titration period. Significant differences favoring ALO-02 compared with placebo were only observed for the SF-36v2 Bodily Pain subscale (p ≤ 0.0232; ITT population) during the double-blind treatment period and the overall study period (screening to the end of the double-blind treatment period). The percentage change in activity impairment due to low back pain subscale of the WPAI:SHP significantly favored ALO-02 compared with placebo for the ITT population when considering the overall study period (p = 0.0040).<bold>Conclusions: </bold>HRQL, work productivity, and activity impairment may be improved with ALO-02 treatment.<bold>Trial Registration: </bold>ClinicalTrials.gov NCT01571362 , registered April 3, 2012. [ABSTRACT FROM AUTHOR]
- Subjects :
- *OXYCODONE
*NALTREXONE
*PAIN management
*LUMBAR pain
*QUALITY of life
*VISUAL analog scale
*PLACEBOS
*THERAPEUTICS
*CONTROLLED release drugs
*THERAPEUTIC use of narcotics
*ANALGESICS
*COMBINATION drug therapy
*COMPARATIVE studies
*HEALTH surveys
*LABOR productivity
*RESEARCH methodology
*MEDICAL cooperation
*QUESTIONNAIRES
*RESEARCH
*EVALUATION research
*PAIN measurement
*RANDOMIZED controlled trials
*TREATMENT effectiveness
*BLIND experiment
Subjects
Details
- Language :
- English
- ISSN :
- 14777525
- Volume :
- 15
- Database :
- Academic Search Index
- Journal :
- Health & Quality of Life Outcomes
- Publication Type :
- Academic Journal
- Accession number :
- 125737184
- Full Text :
- https://doi.org/10.1186/s12955-017-0749-y