• Pain Med · Aug 2019

    Multicenter Study

    An Open-Label, 52-Week, Phase III Trial of Duloxetine in Japanese Patients with Chronic Low Back Pain.

    • Shin-Ichi Konno, Levent Alev, Natsuko Oda, Toshimitsu Ochiai, and Hiroyuki Enomoto.
    • Department of Orthopaedic Surgery, Fukushima Medical University, Fukushima, Japan.
    • Pain Med. 2019 Aug 1; 20 (8): 1479-1488.

    ObjectiveTo evaluate the safety and efficacy of duloxetine treatment for 52 weeks.DesignMulticenter, open-label, phase III clinical study.SettingForty-one medical institutions in Japan.SubjectsJapanese patients with chronic low back pain (CLBP).MethodsDuloxetine 60 mg once-daily was administered for 52 weeks. Safety was evaluated based on adverse events (AEs), vital signs, laboratory test values, electrocardiogram, Columbia-Suicide Severity Rating Scale, and occurrence of falls. The efficacy outcome measures were the Brief Pain Inventory (BPI; average pain, worst pain, least pain, and pain right now), BPI Interference, Patient's Global Impression of Improvement (PGI-I), Clinical Global Impressions of Severity (CGI-S), Roland-Morris Disability Questionnaire-24 (RDQ-24), 36-Item Short-Form Health Survey (SF-36), and European Quality of Life-5 Dimensions Questionnaire (EQ-5D).ResultsIn total, 151 patients (83 who completed a 14-week placebo-controlled superiority trial and 68 newly registered patients) were enrolled. The incidence rates of AEs and adverse drug reactions (ADRs) were 86.1% and 50.3%, respectively. ADRs with an incidence of ≥5% were somnolence, constipation, nausea, and dry mouth. Treatment discontinuation for AEs occurred in 16 patients. A significant reduction in the BPI average pain score (mean ± SD) was observed at all assessment time points from week 2 (-1.02 ± 1.37) to week 50 (-2.26 ± 1.63), compared with baseline. BPI pain severity (worst pain, least pain, and pain right now), BPI Interference, PGI-I, CGI-S, RDQ-24, SF-36, and EQ-5D showed significant improvement.ConclusionJapanese patients with CLBP had significant pain reduction over 52 weeks without new safety concerns.© 2019 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

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