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 hydrocodone 20 to 120 mg tablets (HYD) in opioid-naive and opioid-experienced patients with uncontrolled moderate to severe chronic low back pain (CLBP). RESEARCH DESIGN AND METHODS: The primary endpoint was week 12 pain intensity scores (11-point scale, 0 = no pain) 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 patients 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 pain reduction (p = 0.0016); this result was supported by sensitivity analyses using different approaches to handling missing data. Proportions of patients achieving ≥ 30 and ≥ 50% improvement in pain 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 CLBP in this study. There were no new or unexpected safety concerns detected.
RCT Entities:
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 hydrocodone 20 to 120 mg tablets (HYD) in opioid-naive and opioid-experienced patients with uncontrolled moderate to severe chronic low back pain (CLBP). RESEARCH DESIGN AND METHODS: The primary endpoint was week 12 pain intensity scores (11-point scale, 0 = no pain) 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 patients 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 pain reduction (p = 0.0016); this result was supported by sensitivity analyses using different approaches to handling missing data. Proportions of patients achieving ≥ 30 and ≥ 50% improvement in pain 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 CLBP in this study. There were no new or unexpected safety concerns detected.
Entities:
Keywords:
chronic low back pain; hydrocodone; opioid; randomized controlled trial
Authors: Marta Imamura; Satiko Tomikawa Imamura; Rosa Alves Targino; León Morales-Quezada; Luis C Onoda Tomikawa; Luis G Onoda Tomikawa; Fabio M Alfieri; Thais R Filippo; Ivan D da Rocha; Raul Bolliger Neto; Felipe Fregni; Linamara Rizzo Battistella Journal: J Pain Date: 2016-01-30 Impact factor: 5.820
Authors: David J Kopsky; Karolina M Szadek; Patrick Schober; Alexander F J E Vrancken; Monique A H Steegers Journal: J Pain Res Date: 2022-02-17 Impact factor: 3.133