OBJECTIVE: The aim of this study was to determine the efficacy and tolerability of @entity10748 extended release (ER) in @entity1 with @entity1643 ( @entity1643 ) with or without a neuropathic component. DESIGN: This was a post hoc analysis of data from a multicenter, double-blind, placebo-controlled clinical trial using a randomized withdrawal design, performed in @entity1 with moderate to severe chronic @entity1643 . @entity1 achieving stable doses of @entity10748 ER during a 2- to 4-week conversion and titration phase were randomized to continue treatment with @entity10748 ER or taper-down to placebo during a 12-week double-blind phase. The primary efficacy outcome was the mean change in 11-point Numeric Rating Scale (NRS) @entity158 intensity score from randomization to the final visit of the double-blind phase. Tolerability was assessed by recording adverse events (AEs). Data were analyzed separately for @entity1 with @entity9 . RESULTS: A total of 173 @entity1 with @entity1643 and 94 with @entity1643 were randomized into the double-blind phase. During the conversion and titration phase, mean (SD) NRS scores decreased significantly from 6.5 (1.87) and 6.4 (1.99) at screening to 3.3 (0.98) and 3.2 (1.05), respectively. For both @entity1643 subgroups, @entity1 randomized to @entity10748 ER maintained this improvement over the double-blind treatment period, whereas those randomized to placebo reported significant increase in NRS scores. Across subgroups, the incidence of 1 or more AE was 54 percent to 57 percent in the conversion and titration phase and 47 percent to 55 percent in the double-blind phase. CONCLUSIONS: The results of this study indicate that @entity10748 ER is efficacious and generally well tolerated in the management of @entity1 with @entity9 .

@entity10748 extended release for neuropathic and non-neuropathic/nociceptive XXXX : A post hoc analysis of data from a randomized, multicenter, double-blind, placebo-controlled clinical trial.

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients'] @entity1643 :: ('MESH:D017116', 'Disease') :: ['neuropathic LBP', 'chronic low back pain', 'LBP', 'non-neuropathic/nociceptive LBP'] @entity158 :: ('MESH:D010146', 'Disease') :: ['pain'] @entity10748 :: ('MESH:D004091', 'Chemical') :: ['hydromorphone'] @entity9 :: ('MESH:D009437', 'Disease') :: ['non-neuropathic and neuropathic LBP', 'non-neuropathic and neuropathic chronic LBP']
@entity1643 :: (MESH:D017116,Disease) :: ['chronic low back pain']
