1. Single-Entity Hydrocodone Extended-Release Capsules in Opioid-Tolerant Subjects with Moderate-to-Severe Chronic Low Back Pain: A Randomized Double-Blind, Placebo-Controlled Study.
- Author
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Rauck, Richard L., Nalamachu, Srinivas, Wild, James E., Walker, George S., Robinson, Cynthia Y., Davis, Charles S., and Farr, Stephen J.
- Subjects
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ANALYSIS of covariance , *BACKACHE , *CHI-squared test , *CHRONIC diseases , *CODEINE , *CONTROLLED release preparations , *STATISTICAL correlation , *FISHER exact test , *NARCOTICS , *HEALTH outcome assessment , *RESEARCH funding , *T-test (Statistics) , *RANDOMIZED controlled trials , *TREATMENT effectiveness , *BLIND experiment , *DESCRIPTIVE statistics , *KAPLAN-Meier estimator , *LOG-rank test - Abstract
Objective A single-agent, extended-release formulation of hydrocodone (HC) has been developed for treatment of chronic moderate-to-severe pain. This study was designed to examine the safety and efficacy of HC extended release in opioid-experienced adults with moderate-to-severe chronic low back pain (CLBP). Methods This multicenter, enriched enrollment, randomized withdrawal study comprised an open-label conversion/titration phase (≤6 weeks) followed by placebo-controlled, double-blind treatment (12 weeks). During the conversion/titration phase, subjects (N = 510) converted from their current opioid and were titrated to a stabilized dose of HC extended release (20−100 mg every 12 hours). During treatment, subjects (N = 151 per group) received HC extended release or placebo; rescue medication was permitted. The primary efficacy end point was mean change in average pain intensity from baseline to day 85. Response rates (30% pain improvement) and satisfaction ( Subject Global Assessment of Medication) were assessed. Results Demographic and baseline characteristics were similar between groups. Mean ± SD change in average pain intensity score from baseline to day 85 was significantly lower in the HC extended-release treatment group vs placebo (0.48 ± 1.56 vs 0.96 ± 1.55; P = 0.008). Significantly more responders were in the treatment group (68% vs 31%; P < 0.001). Mean Subject Global Assessment of Medication scores increased significantly (0.8 ± 1.3 vs 0.0 ± 1.4; P < 0.0001), indicating greater satisfaction with HC extended release. The adverse event profile was consistent with other opioids. Conclusions Extended-release HC is well tolerated and effective, without acetaminophen-associated risks of liver toxicity, for treatment of CLBP. [ABSTRACT FROM AUTHOR]
- Published
- 2014
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