{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,30]],"date-time":"2026-01-30T23:49:26Z","timestamp":1769816966774,"version":"3.49.0"},"reference-count":38,"publisher":"Oxford University Press (OUP)","issue":"8","license":[{"start":{"date-parts":[[2019,3,11]],"date-time":"2019-03-11T00:00:00Z","timestamp":1552262400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"funder":[{"name":"Shionogi & Co., Ltd."}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2019,8,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Objective<\/jats:title>\n                  <jats:p>To evaluate the safety and efficacy of duloxetine treatment for 52\u2009weeks.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Design<\/jats:title>\n                  <jats:p>Multicenter, open-label, phase III clinical study.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Setting<\/jats:title>\n                  <jats:p>Forty-one medical institutions in Japan.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Subjects<\/jats:title>\n                  <jats:p>Japanese patients with chronic low back pain (CLBP).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Duloxetine 60\u2009mg once-daily was administered for 52\u2009weeks. 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\u2019s Global Impression of Improvement (PGI-I), Clinical Global Impressions of Severity (CGI-S), Roland-Morris Disability Questionnaire\u201324 (RDQ-24), 36-Item Short-Form Health Survey (SF-36), and European Quality of Life-5 Dimensions Questionnaire (EQ-5D).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>In 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 \u22655% 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 \u00b1 SD) was observed at all assessment time points from week 2 (\u22121.02\u2009\u00b1\u20091.37) to week 50 (\u22122.26\u2009\u00b1\u20091.63), 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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>Japanese patients with CLBP had significant pain reduction over 52\u2009weeks without new safety concerns.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/pm\/pnz027","type":"journal-article","created":{"date-parts":[[2019,2,1]],"date-time":"2019-02-01T09:10:42Z","timestamp":1549012242000},"page":"1479-1488","source":"Crossref","is-referenced-by-count":5,"title":["An Open-Label, 52-Week, Phase III Trial of Duloxetine in Japanese Patients with Chronic Low Back Pain"],"prefix":"10.1093","volume":"20","author":[{"given":"Shin-ichi","family":"Konno","sequence":"first","affiliation":[{"name":"Department of Orthopaedic Surgery, Fukushima Medical University, Fukushima, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Levent","family":"Alev","sequence":"additional","affiliation":[{"name":"Eli Lilly Turkey, Istanbul, Turkey"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Natsuko","family":"Oda","sequence":"additional","affiliation":[{"name":"Shionogi & Co., Ltd., Osaka, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Toshimitsu","family":"Ochiai","sequence":"additional","affiliation":[{"name":"Shionogi & Co., Ltd., Osaka, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hiroyuki","family":"Enomoto","sequence":"additional","affiliation":[{"name":"Eli Lilly Japan K.K., Kobe, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2019,3,11]]},"reference":[{"key":"2019080802245634500_pnz027-B1","doi-asserted-by":"crossref","first-page":"432","DOI":"10.1007\/s00586-012-2439-0","article-title":"Prevalence of low back pain and factors associated with chronic disabling back pain in Japan","volume":"2","author":"Fujii","year":"2013","journal-title":"Eur Spine J"},{"key":"2019080802245634500_pnz027-B2","first-page":"437","article-title":"Epidemiology of low back pain \u2013 from a large scale epidemiologic survey \u201cROAD.\u201d","volume":"84","author":"Yoshimura","year":"2010","journal-title":"Nippon Seikei Geka Gakkai Zasshi"},{"key":"2019080802245634500_pnz027-B3","first-page":"119","article-title":"The association between lower back pain and health status, work productivity, and health care resource use in Japan","volume":"8","author":"Sadosky","year":"2015","journal-title":"J Pain Res"},{"issue":"2","key":"2019080802245634500_pnz027-B4","doi-asserted-by":"crossref","first-page":"339","DOI":"10.1007\/s00776-013-0525-8","article-title":"Prevalence and characteristics of chronic musculoskeletal pain in Japan: A second survey of people with or without chronic pain","volume":"19","author":"Nakamura","year":"2014","journal-title":"J Orthop Sci"},{"key":"2019080802245634500_pnz027-B5","doi-asserted-by":"crossref","first-page":"S192","DOI":"10.1007\/s00586-006-1072-1","article-title":"Chapter 4. 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