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An Open-Label, 52-Week, Phase III Trial of Duloxetine in Japanese Patients with Chronic Low Back Pain.
- Source :
-
Pain Medicine . Aug2019, Vol. 20 Issue 8, p1479-1488. 10p. 2 Diagrams, 4 Charts, 4 Graphs. - Publication Year :
- 2019
-
Abstract
- Objective To evaluate the safety and efficacy of duloxetine treatment for 52 weeks. Design Multicenter, open-label, phase III clinical study. Setting Forty-one medical institutions in Japan. Subjects Japanese patients with chronic low back pain (CLBP). Methods Duloxetine 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). Results 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 ≥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. Conclusion Japanese patients with CLBP had significant pain reduction over 52 weeks without new safety concerns. [ABSTRACT FROM AUTHOR]
- Subjects :
- *SUICIDE risk factors
*CONSTIPATION
*NAUSEA
*ACADEMIC medical centers
*CHRONIC pain
*CLINICAL trials
*FUNCTIONAL assessment
*DROWSINESS
*DRUG side effects
*ELECTROCARDIOGRAPHY
*ACCIDENTAL falls
*MEDICAL cooperation
*QUESTIONNAIRES
*REFERENCE values
*RESEARCH
*PAIN management
*TERMINATION of treatment
*PAIN measurement
*TREATMENT effectiveness
*DISEASE incidence
*SEVERITY of illness index
*DULOXETINE
*XEROSTOMIA
*BRIEF Pain Inventory
*LUMBAR pain
*DISEASE risk factors
*THERAPEUTICS
RISK factors
Subjects
Details
- Language :
- English
- ISSN :
- 15262375
- Volume :
- 20
- Issue :
- 8
- Database :
- Academic Search Index
- Journal :
- Pain Medicine
- Publication Type :
- Academic Journal
- Accession number :
- 138057709
- Full Text :
- https://doi.org/10.1093/pm/pnz027