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Volumn 41, Issue 22, 2016, Pages 1709-1717

Randomized, double-blind, placebo-controlled phase III trial of duloxetine monotherapy in Japanese patients with chronic low back pain

Author keywords

Brief Pain Inventory; Chronic low back pain; Duloxetine; Efficacy; Japan; Placebo; Randomized clinical trial; Safety; Serotonin norepinephrine reuptake inhibitor

Indexed keywords

DULOXETINE; PLACEBO;

EID: 84970046064     PISSN: 03622436     EISSN: 15281159     Source Type: Journal    
DOI: 10.1097/BRS.0000000000001707     Document Type: Article
Times cited : (64)

References (37)
  • 1
    • 84880499263 scopus 로고    scopus 로고
    • Prevalence of low back pain and factors associated with chronic disabling back pain in Japan
    • Fujii T, Matsudaira K. Prevalence of low back pain and factors associated with chronic disabling back pain in Japan. Eur Spine J 2013;22:432-8.
    • (2013) Eur Spine J , vol.22 , pp. 432-438
    • Fujii, T.1    Matsudaira, K.2
  • 2
    • 84996467616 scopus 로고    scopus 로고
    • Epidemiology of low back pain: From a large scale epidemiologic survey "ROAD''
    • Yoshimura N, Muraki S, Oka T, et al. Epidemiology of low back pain: from a large scale epidemiologic survey "ROAD''. Nippon Seikei Geka Gakkai Zasshi 2010;84:437-9.
    • (2010) Nippon Seikei Geka Gakkai Zasshi , vol.84 , pp. 437-439
    • Yoshimura, N.1    Muraki, S.2    Oka, T.3
  • 3
    • 84897429352 scopus 로고    scopus 로고
    • Prevalence and characteristics of chronic musculoskeletal pain in Japan: A second survey of people with or without chronic pain
    • Nakamura M, Nishiwaki Y, Ushida T, et al. Prevalence and characteristics of chronic musculoskeletal pain in Japan: A second survey of people with or without chronic pain. J Orthop Sci 2014;19:339-50.
    • (2014) J Orthop Sci , vol.19 , pp. 339-350
    • Nakamura, M.1    Nishiwaki, Y.2    Ushida, T.3
  • 4
    • 0042133416 scopus 로고    scopus 로고
    • Acute low back pain: Systematic review of its prognosis
    • Pengel LH, Herbert RD, Mather CG, et al. Acute low back pain: systematic review of its prognosis. BMJ 2003;327:323.
    • (2003) BMJ , vol.327 , pp. 323
    • Pengel, L.H.1    Herbert, R.D.2    Mather, C.G.3
  • 5
    • 33645214923 scopus 로고    scopus 로고
    • COST B13 Working Group on Guidelines for Chronic Low Back Pain. Chapter 4. European guidelines for the management of chronic nonspecific low back pain
    • Airaksinen O, Brox JI, Cedraschi C, et al. COST B13 Working Group on Guidelines for Chronic Low Back Pain. Chapter 4. European guidelines for the management of chronic nonspecific low back pain. Eur Spine J 2006;S192-300.
    • (2006) Eur Spine J , pp. S192-S300
    • Airaksinen, O.1    Brox, J.I.2    Cedraschi, C.3
  • 6
    • 34848826292 scopus 로고    scopus 로고
    • Medications for acute and chronic low back pain: A review of the evidence for an American pain society/American college of physicians clinical practice guideline
    • American Pain Society
    • Chou R, Huffman LH, American Pain Society. Medications for acute and chronic low back pain: A review of the evidence for an American Pain Society/American College of Physicians clinical practice guideline. Ann Intern Med 2007;147:505-14.
    • (2007) Ann Intern Med , vol.147 , pp. 505-514
    • Chou, R.1    Huffman, L.H.2
  • 8
    • 0034307534 scopus 로고    scopus 로고
    • Nonsteroidal antiinflammatory drugs for low back pain: A systematic review within the framework of the Cochrane Collaboration Back Review Group
    • van Tulder MW, Scholten RJ, Koes BW, et al. Nonsteroidal antiinflammatory drugs for low back pain: A systematic review within the framework of the Cochrane Collaboration Back Review Group. Spine (Phila Pa 1976) 2000;25:2501-13.
    • (2000) Spine (Phila Pa 1976) , vol.25 , pp. 2501-2513
    • Van Tulder, M.W.1    Scholten, R.J.2    Koes, B.W.3
  • 9
    • 84857559117 scopus 로고    scopus 로고
    • Adverse drug reactions of nonsteroidal antiinflammatory drugs in orthopedic patients
    • Gor AP, Saksena M. Adverse drug reactions of nonsteroidal antiinflammatory drugs in orthopedic patients. J Pharmacol Pharmacother 2011;2:26-9.
    • (2011) J Pharmacol Pharmacother , vol.2 , pp. 26-29
    • Gor, A.P.1    Saksena, M.2
  • 10
    • 13244284671 scopus 로고    scopus 로고
    • Efficacy of duloxetine, a potent and balanced serotonergic and noradrenergic reuptake inhibitor, in inflammatory and acute pain models in rodents
    • Jones CK, Peters SC, Shannon HE. Efficacy of duloxetine, a potent and balanced serotonergic and noradrenergic reuptake inhibitor, in inflammatory and acute pain models in rodents. J Pharmacol Exp Ther 2005;312:726-32.
    • (2005) J Pharmacol Exp Ther , vol.312 , pp. 726-732
    • Jones, C.K.1    Peters, S.C.2    Shannon, H.E.3
  • 11
    • 78649681292 scopus 로고    scopus 로고
    • Duloxetine versus placebo in patients with chronic low back pain: A 12-week, fixed-dose, randomized, double-blind trial
    • Skljarevski V, Zhang S, Desaiah D, et al. Duloxetine versus placebo in patients with chronic low back pain: A 12-week, fixed-dose, randomized, double-blind trial. J Pain 2010;11:1282-90.
    • (2010) J Pain , vol.11 , pp. 1282-1290
    • Skljarevski, V.1    Zhang, S.2    Desaiah, D.3
  • 12
    • 77953139865 scopus 로고    scopus 로고
    • Efficacy and safety of duloxetine in patients with chronic low back pain
    • Skljarevski V, Desaiah D, Liu-Seifert H, et al. Efficacy and safety of duloxetine in patients with chronic low back pain. Spine (Phila Pa 1976) 2010;35:E578-85.
    • (2010) Spine (Phila Pa 1976) , vol.35 , pp. E578-E585
    • Skljarevski, V.1    Desaiah, D.2    Liu-Seifert, H.3
  • 13
    • 68849124206 scopus 로고    scopus 로고
    • A double-blind, randomized trial of duloxetine versus placebo in the management of chronic low back pain
    • Skljarevski V, Ossanna M, Liu-Seifert H, et al. A double-blind, randomized trial of duloxetine versus placebo in the management of chronic low back pain. Eur J Neurol 2009;16:1041-8.
    • (2009) Eur J Neurol , vol.16 , pp. 1041-1048
    • Skljarevski, V.1    Ossanna, M.2    Liu-Seifert, H.3
  • 14
    • 78650925915 scopus 로고    scopus 로고
    • Clinical evaluation of duloxetine in the treatment of major depressive disorder-placebo-and paroxetine-controlled double-blind comparative study
    • Higuchi T, Murasaki M, Kamijima K. Clinical evaluation of duloxetine in the treatment of major depressive disorder-placebo-and paroxetine-controlled double-blind comparative study. Jpn J Clin Psychopharmacol 2009;12:1613-34.
    • (2009) Jpn J Clin Psychopharmacol , vol.12 , pp. 1613-1634
    • Higuchi, T.1    Murasaki, M.2    Kamijima, K.3
  • 15
    • 79961092686 scopus 로고    scopus 로고
    • Superiority of duloxetine to placebo in improving diabetic neuropathic pain: Results of a randomized controlled trial in Japan
    • Hitoshi Yasuda, Hotta N, Nakao K, et al. Superiority of duloxetine to placebo in improving diabetic neuropathic pain: results of a randomized controlled trial in Japan. J Diabetes Investig 2011;2: 132-9.
    • (2011) J Diabetes Investig , vol.2 , pp. 132-139
    • Yasuda, H.1    Hotta, N.2    Nakao, K.3
  • 16
    • 84939640957 scopus 로고    scopus 로고
    • A randomized, doubleblind, placebo-controlled phase III trial of duloxetine in Japanese fibromyalgia patients
    • Murakami M, Osada K, Mizuno H, et al. A randomized, doubleblind, placebo-controlled phase III trial of duloxetine in Japanese fibromyalgia patients. Arthritis Res Ther 2015;17:224.
    • (2015) Arthritis Res Ther , vol.17 , pp. 224
    • Murakami, M.1    Osada, K.2    Mizuno, H.3
  • 17
    • 0032417330 scopus 로고    scopus 로고
    • A brief cancer pain assessment tool in Japanese: The utility of the Japanese Brief Pain Inventory-BPI-J
    • Uki J, Mendoza T, Cleeland CS, et al. A brief cancer pain assessment tool in Japanese: the utility of the Japanese Brief Pain Inventory-BPI-J. J Pain Symptom Manage December 1998;16: 364-73.
    • (1998) J Pain Symptom Manage December , vol.16 , pp. 364-373
    • Uki, J.1    Mendoza, T.2    Cleeland, C.S.3
  • 18
    • 0032421570 scopus 로고    scopus 로고
    • The Mini-International Neuropsychiatric Interview (M. I. N. I.): The development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10
    • Sheehan DV, Lecrubier Y, Sheehan KH, et al. The Mini-International Neuropsychiatric Interview (M. I. N. I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry 1998;59:22-33.
    • (1998) J Clin Psychiatry , vol.59 , pp. 22-33
    • Sheehan, D.V.1    Lecrubier, Y.2    Sheehan, K.H.3
  • 19
    • 84863393105 scopus 로고    scopus 로고
    • The Columbia-Suicide Severity Rating Scale: Initial validity and internal consistency findings from three multisite studies with adolescents and adults
    • Posner K, Brown GK, Stanley B, et al. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry 2011;168:1266-77.
    • (2011) Am J Psychiatry , vol.168 , pp. 1266-1277
    • Posner, K.1    Brown, G.K.2    Stanley, B.3
  • 20
    • 0003412410 scopus 로고
    • US Department of Health, Education, and Welfare publication (ADM). Rockville, MD: National Institute of Mental Health
    • Guy W. ECDEU Assessment Manual for Psychopharmacology, Revised. US Department of Health, Education, and Welfare publication (ADM). Rockville, MD: National Institute of Mental Health; 1976;76-338.
    • (1976) ECDEU Assessment Manual for Psychopharmacology, Revised , pp. 76-338
    • Guy, W.1
  • 21
    • 0020583112 scopus 로고
    • A study of the natural history of back pain Part i development of a reliable and sensitive measure of disability in low-back pain
    • Roland M, Morris R. A study of the natural history of back pain. Part I: development of a reliable and sensitive measure of disability in low-back pain. Spine (Phila Pa 1976) 1983;8:141-4.
    • (1983) Spine (Phila Pa 1976) , vol.8 , pp. 141-144
    • Roland, M.1    Morris, R.2
  • 23
    • 0043014810 scopus 로고    scopus 로고
    • Validation of the Japanese version of the Roland-Morris Disability Questionnaire
    • Suzukamo Y, Fukuhara S, Kikuchi S, et al. Validation of the Japanese version of the Roland-Morris Disability Questionnaire. J Orthop Sci 2003;8:543-8.
    • (2003) J Orthop Sci , vol.8 , pp. 543-548
    • Suzukamo, Y.1    Fukuhara, S.2    Kikuchi, S.3
  • 24
    • 0032211622 scopus 로고    scopus 로고
    • Translation, adaptation, and validation of the SF-36 Health Survey for use in Japan
    • Fukuhara S, Bito S, Green J, et al. Translation, adaptation, and validation of the SF-36 Health Survey for use in Japan. J Clin Epidemiol 1998;51:1037-44.
    • (1998) J Clin Epidemiol , vol.51 , pp. 1037-1044
    • Fukuhara, S.1    Bito, S.2    Green, J.3
  • 25
    • 18744419661 scopus 로고    scopus 로고
    • Psychometric and clinical tests of validity of the Japanese SF-36 Health Survey
    • Fukuhara S, Ware JE Jr, Kosinski M, et al. Psychometric and clinical tests of validity of the Japanese SF-36 Health Survey. J Clin Epidemiol 1998;51:1045-53.
    • (1998) J Clin Epidemiol , vol.51 , pp. 1045-1053
    • Fukuhara, S.1    Ware, J.E.2    Kosinski, M.3
  • 26
    • 0003068836 scopus 로고    scopus 로고
    • The EuroQoL instrument: An index of health-related quality of life
    • In: Spilker B, editor, 2nd ed. Philadelphia, PA: Lippincott-Raven Publishers
    • Kind P. The EuroQoL instrument: An index of health-related quality of life. In: Spilker B, editor. Quality of Life and Pharmacoeconomics in Clinical Trials, 2nd ed. Philadelphia, PA: Lippincott-Raven Publishers; 1996. pp. 191-201.
    • (1996) Quality of Life and Pharmacoeconomics in Clinical Trials , pp. 191-201
    • Kind, P.1
  • 27
    • 0027693577 scopus 로고
    • The validity and reproducibility of a work productivity and activity impairment instrument
    • Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics 1993;4:353-65.
    • (1993) Pharmacoeconomics , vol.4 , pp. 353-365
    • Reilly, M.C.1    Zbrozek, A.S.2    Dukes, E.M.3
  • 28
    • 38549181857 scopus 로고    scopus 로고
    • Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations
    • Dworkin RH, Turk DC, Wyrwich KW, et al. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain 2008;9:105-21.
    • (2008) J Pain , vol.9 , pp. 105-121
    • Dworkin, R.H.1    Turk, D.C.2    Wyrwich, K.W.3
  • 29
    • 0034871011 scopus 로고    scopus 로고
    • A systematic review of the associations between dose regimens and medication compliance
    • Claxton AJ, Cramer J, Pierce C. A systematic review of the associations between dose regimens and medication compliance. Clin Ther 2001;23:1296-310.
    • (2001) Clin Ther , vol.23 , pp. 1296-1310
    • Claxton, A.J.1    Cramer, J.2    Pierce, C.3
  • 30
    • 20444464304 scopus 로고    scopus 로고
    • Duloxetine vs. Placebo in patients with painful diabetic neuropathy
    • Goldstein DJ, Lu Y, Detke MJ, et al. Duloxetine vs. placebo in patients with painful diabetic neuropathy. Pain 2005;116:109-18.
    • (2005) Pain , vol.116 , pp. 109-118
    • Goldstein, D.J.1    Lu, Y.2    Detke, M.J.3
  • 31
    • 28444459170 scopus 로고    scopus 로고
    • A double-blind, randomized multicenter trial comparing duloxetine with placebo in the management of diabetic peripheral neuropathic pain
    • Raskin J, Pritchett YL, Wang F, et al. A double-blind, randomized multicenter trial comparing duloxetine with placebo in the management of diabetic peripheral neuropathic pain. Pain Med 2005;6:346-56.
    • (2005) Pain Med , vol.6 , pp. 346-356
    • Raskin, J.1    Pritchett, Y.L.2    Wang, F.3
  • 32
    • 33750341692 scopus 로고    scopus 로고
    • A randomized controlled trial of duloxetine in diabetic peripheral neuropathic pain
    • Wernicke JF, Pritchett YL, D'Souza DN, et al. A randomized controlled trial of duloxetine in diabetic peripheral neuropathic pain. Neurology 2006;67:1411-20.
    • (2006) Neurology , vol.67 , pp. 1411-1420
    • Wernicke, J.F.1    Pritchett, Y.L.2    D'Souza, D.N.3
  • 33
    • 84862908787 scopus 로고    scopus 로고
    • Efficacy of duloxetine in patients with fibromyalgia: Pooled analysis of 4 placebocontrolled clinical trials
    • Arnold LM, Clauw DJ, Wohlreich MM, et al. Efficacy of duloxetine in patients with fibromyalgia: pooled analysis of 4 placebocontrolled clinical trials. Prim Care Companion J Clin Psychiatry 2009;11:237-44.
    • (2009) Prim Care Companion J Clin Psychiatry , vol.11 , pp. 237-244
    • Arnold, L.M.1    Clauw, D.J.2    Wohlreich, M.M.3
  • 34
    • 70350462006 scopus 로고    scopus 로고
    • Safety and tolerability of duloxetine in the treatment of patients with fibromyalgia: Pooled analysis of data from five clinical trials
    • Choy EH, Mease PJ, Kajdasz DK, et al. Safety and tolerability of duloxetine in the treatment of patients with fibromyalgia: pooled analysis of data from five clinical trials. Clin Rheumatol 2009;28:1035-44.
    • (2009) Clin Rheumatol , vol.28 , pp. 1035-1044
    • Choy, E.H.1    Mease, P.J.2    Kajdasz, D.K.3
  • 35
    • 70350619997 scopus 로고    scopus 로고
    • Duloxetine, a centrally acting analgesic, in the treatment of patients with osteoarthritis knee pain: A 13-week, randomized, placebo-controlled trial
    • Chappell AS, Ossanna MJ, Liu-Seifert H, et al. Duloxetine, a centrally acting analgesic, in the treatment of patients with osteoarthritis knee pain: A 13-week, randomized, placebo-controlled trial. Pain 2009;146:253-60.
    • (2009) Pain , vol.146 , pp. 253-260
    • Chappell, A.S.1    Ossanna, M.J.2    Liu-Seifert, H.3
  • 36
    • 78651430475 scopus 로고    scopus 로고
    • A double-blind, randomized, placebo-controlled study of the efficacy and safety of duloxetine for the treatment of chronic pain due to osteoarthritis of the knee
    • Chappell AS, Desaiah D, Liu-Seifert H, et al. A double-blind, randomized, placebo-controlled study of the efficacy and safety of duloxetine for the treatment of chronic pain due to osteoarthritis of the knee. Pain Pract 2011;11:33-41.
    • (2011) Pain Pract , vol.11 , pp. 33-41
    • Chappell, A.S.1    Desaiah, D.2    Liu-Seifert, H.3


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