OBJECTIVES: This multicenter, randomized, double-blind, placebo-controlled study with an enriched enrollment, randomized withdrawal design was conducted to evaluate the analgesic efficacy and safety of single-entity, once-daily @entity1287 20 to 120 mg tablets (HYD) in opioid-naive and opioid-experienced @entity1 with uncontrolled moderate to severe @entity1643 ( @entity1643 ). RESEARCH DESIGN AND METHODS: The primary endpoint was week 12 @entity158 intensity scores (11-point scale, 0 = no @entity158 ) using a mixed effect model with repeated measures incorporating a pattern mixture model framework. Responder analysis was a secondary endpoint. Safety was assessed. RESULTS: Out of 905 @entity1 who were treated with HYD during the open-label titration period, 588 (65%) were randomized to continue to receive HYD (n = 296, 20 - 120 mg taken once daily, average daily dose 57 mg) or a matching placebo (n = 292). HYD demonstrated superior @entity158 reduction (p = 0.0016); this result was supported by sensitivity analyses using different approaches to handling missing data. Proportions of @entity1 achieving >=  30 and >=  50% improvement in @entity158 from screening to week 12 also favored HYD (p = 0.0033 and 0.0225, respectively). HYD was generally well tolerated. CONCLUSIONS: HYD was shown to be an efficacious treatment for @entity1643 in this study. There were no new or unexpected safety concerns detected.

A multicenter, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of single-entity, once-daily @entity1287 tablets in @entity1 with uncontrolled moderate to severe XXXX .

@entity1 :: ('9606', 'Species') :: ['patients'] @entity1643 :: ('MESH:D017116', 'Disease') :: ['chronic low back pain', 'CLBP'] @entity158 :: ('MESH:D010146', 'Disease') :: ['pain'] @entity1287 :: ('MESH:D006853', 'Chemical') :: ['hydrocodone']
@entity1643 :: (MESH:D017116,Disease) :: ['chronic low back pain']
