Abstract | OBJECTIVE: 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.
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Authors | Richard L Rauck, Srinivas Nalamachu, James E Wild, George S Walker, Cynthia Y Robinson, Charles S Davis, Stephen J Farr |
Journal | Pain medicine (Malden, Mass.)
(Pain Med)
Vol. 15
Issue 6
Pg. 975-85
(Jun 2014)
ISSN: 1526-4637 [Electronic] England |
PMID | 24517082
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Wiley Periodicals, Inc. |
Chemical References |
- Analgesics, Opioid
- Delayed-Action Preparations
- Hydrocodone
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Topics |
- Adolescent
- Adult
- Aged
- Analgesics, Opioid
(administration & dosage)
- Chronic Pain
(diagnosis, drug therapy)
- Delayed-Action Preparations
(administration & dosage)
- Double-Blind Method
- Drug Tolerance
- Female
- Humans
- Hydrocodone
(administration & dosage)
- Low Back Pain
(diagnosis, drug therapy)
- Male
- Middle Aged
- Pain Measurement
(drug effects, methods)
- Severity of Illness Index
- Young Adult
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