A5053291346- Platelet Disorders and Treatments
- Musculoskeletal pain and rehabilitation
- Statistical Methods in Clinical Trials
- Myeloproliferative Neoplasms: Diagnosis and Treatment
- Health Systems, Economic Evaluations, Quality of Life
- Antiplatelet Therapy and Cardiovascular Diseases
- Optimal Experimental Design Methods
- Fibromyalgia and Chronic Fatigue Syndrome Research
- Pain Mechanisms and Treatments
- Pain Management and Placebo Effect
- Advanced Causal Inference Techniques
- Lipid metabolism and disorders
- Treatment of Major Depression
- Gastric Cancer Management and Outcomes
- Chronic Myeloid Leukemia Treatments
- Liver physiology and pathology
- Venous Thromboembolism Diagnosis and Management
- Liver Disease and Transplantation
- Liver Disease Diagnosis and Treatment
- Osteoarthritis Treatment and Mechanisms
- Heparin-Induced Thrombocytopenia and Thrombosis
- Urticaria and Related Conditions
- Healthcare professionals’ stress and burnout
- Gastrointestinal Bleeding Diagnosis and Treatment
- Meta-analysis and systematic reviews
Shionogi (Japan)
2015-2022
Osaka University
2016
Shimane University
2003
Thrombocytopenia may be associated with increased bleeding risk impacting timing and outcome of invasive procedures in patients chronic liver disease (CLD). Lusutrombopag, a small‐molecule, thrombopoietin (TPO) receptor agonist, was evaluated as treatment to raise platelet counts (PCs) thrombocytopenia CLD undergoing procedures. L‐PLUS 2 global, phase 3, randomized, double‐blind, placebo‐controlled study. Adults baseline PCs < 50 × 10 9 /L were randomized receive once‐daily lusutrombopag...
Background & AimsPlatelet transfusion is used to prevent hemorrhagic events in patients with thrombocytopenia undergoing invasive procedures, but there are many disadvantages. We evaluated the efficacy and safety of lusutrombopag chronic liver disease procedures.MethodsWe performed a double-blind, parallel-group, phase 3 study 96 (platelet counts below 50,000/μL) procedures from October 2013 May 2014 at 81 centers Japan. Patients were randomly assigned (1:1) groups given once-daily (3 mg) or...
Study Design. A 14-week, randomized, double-blind, multicenter, placebo-controlled study of Japanese patients with chronic low back pain (CLBP) who were randomized to either duloxetine 60 mg once daily or placebo. Objective. This aimed assess the efficacy and safety monotherapy in CLBP. Summary Background Data. In Japan, is approved for treatment depression, diabetic neuropathic pain, associated fibromyalgia; however, no clinical has been conducted Methods. The primary measure was change...
Thrombocytopenia represents an obstacle for invasive procedures in chronic liver disease (CLD) patients. We aimed to estimate the appropriate dose and evaluate efficacy safety of lusutrombopag treatment thrombocytopenia before percutaneous radiofrequency ablation (RFA) primary hepatic cancer patients with CLD.In this multicenter, randomized, double-blind, placebo-controlled study conducted Japan, 61 CLD platelet count < 50 × 103/µL at screening were randomized placebo or 2, 3, 4 mg once...
Abstract Aim The study aimed to assess the efficacy and safety of SDT‐001, a digital therapeutic, in Japanese children adolescents with attention‐deficit/hyperactivity disorder (ADHD). Methods This phase 2, multicenter, randomized, double‐blind, sham‐controlled (jRCT1080225158) was conducted for duration up 14 weeks. After screening, eligible participants were randomized receive SDT‐001 or single‐task intervention 25 min/day 6 weeks followed 4 after intervention. A post hoc analysis also...
To examine the efficacy and safety of duloxetine in Japanese patients with knee pain due to osteoarthritis. Patients were randomized receive 60 mg/day or placebo for 14 weeks a double-blind manner (ClinicalTrials.gov Identifier: NCT02248480). The primary endpoint was mean change Brief Pain Inventory severity (BPI-Severity) average pain. Secondary endpoints included improvement other BPI-Severity scales, Patient Global Impression Improvement, Clinical Impressions Severity, health-related...
To assess long-term safety, tolerability, and efficacy of duloxetine in Japanese patients with chronic knee pain due to osteoarthritis.In this open-label extension study (NCT02335346), osteoarthritis (Brief Pain Inventory [BPI] - Severity average score ≥4 at start randomized trial) who had previously received 60 mg/day or placebo for 14 weeks a double-blind trial entered the 48 weeks. The primary outcome was safety/tolerability, secondary outcomes were change BPI-Severity (BPI-S) pain,...
Central sensitization, including dysfunction of descending inhibitory pain pathways, may contribute to multisite in patients with chronic musculoskeletal conditions. Duloxetine is a centrally acting analgesic that effectively reduces knee osteoarthritis. Here we assessed the efficacy duloxetine (60 mg/day) Japanese (N = 353) due osteoarthritis based on number painful body sites, determined using Michigan Body Map. Post hoc analysis phase 3, randomized, placebo-controlled trial...
Objectives: We aimed to evaluate the long-term safety and efficacy of duloxetine 60 mg in Japanese patients with fibromyalgia enrolled from a preceding randomized, placebo-controlled, phase III trial. Methods: This was long-term, open-label extension study. Patients received oral once daily at dose 20 for 1 week, followed by 40 then 48 weeks. The primary outcome frequency adverse events (AEs) drug reactions (ADRs) duloxetine. Efficacy health outcomes were assessed. Results: In total, 149...
We discuss group-sequential three-arm noninferiority clinical trial designs that include active and placebo controls for evaluating both assay sensitivity noninferiority. extend two existing approaches, the fixed margin fraction into a setting with decision-making frameworks. investigate operating characteristics including power, Type I error rate, maximum, expected sample sizes, as design factors vary. In addition, we size recalculation its impact on power rate via simulation study.
Despite limitations, platelet transfusion has been used to minimise bleeding risk in patients with thrombocytopaenia. Lusutrombopag is an oral, thrombopoietin receptor agonist approved for treatment of thrombocytopaenia associated chronic liver disease undergoing planned invasive procedures. This
Objective: The goal of this study was to evaluate the efficacy and safety duloxetine in children adolescents (9–17 years age) with major depressive disorder (MDD) Japan. Methods: This consists two clinical trials. First, a 6-week, randomized double-blind placebo-controlled trial (RCT) conducted. primary endpoint RCT change Children's Depression Rating Scale-Revised (CDRS-R) total scores from baseline. Following RCT, an open-label long-term extension (OLE) conducted investigate longer-term...
Duloxetine is efficacious for chronic low back pain (CLBP). This post hoc analysis of a Japanese randomized, placebo-controlled trial (ClinicalTrials.gov, NCT01855919) assessed whether patients with CLBP early reduction or treatment-related adverse events special interest (TR-AESIs; nausea, somnolence, constipation) have enhanced responses to duloxetine.Patients (N = 456) ≥6 months and Brief Pain Inventory (BPI) average severity score ≥4 were randomized (1:1) duloxetine 60 mg/day placebo 14...
To evaluate the safety and efficacy of duloxetine treatment for 52 weeks.Multicenter, open-label, phase III clinical study.Forty-one medical institutions in Japan.Japanese patients with chronic low back pain (CLBP).Duloxetine 60 mg once-daily was administered weeks. Safety evaluated based on adverse events (AEs), vital signs, laboratory test values, electrocardiogram, Columbia-Suicide Severity Rating Scale, occurrence falls. The outcome measures were Brief Pain Inventory (BPI; average pain,...
Lusutrombopag is approved for thrombocytopenia in chronic liver disease patients planned to undergo invasive procedures. In previous clinical studies, lusutrombopag treatment was stopped with an increase platelet count (PC) of ≥20 × 109 /L from baseline and whose PC ≥50 (discontinuation criteria). We assessed the influence monitoring during lusutrombopag-naïve patients.In this open-label study, Child-Pugh class A B (A/B) were enrolled treated (3 mg/day) 7 days. treatment-naïve A/B-1 group,...
To assess whether patients with knee osteoarthritis pain who have early reduction or treatment-related adverse events of special interest (TR-AESIs; constipation, decreased appetite, malaise, nausea, somnolence, thirst) duloxetine treatment are more likely to later improvements in and quality life (QOL) relative placebo than without these indicators.This was a post hoc analysis 14-week randomized trial Japanese (Brief Pain Inventory [BPI]-Severity average score ≥4) receiving 60 mg/day (n=177...
Two previous phase 3, double-blind, randomized, placebo-controlled trials showed that duloxetine 60 mg/day for 14 weeks significantly improved pain and quality of life in Japanese patients with knee osteoarthritis or chronic low back pain. In their open-label extension studies, these improvements were maintained ≥48 weeks. This post-hoc analysis assessed the relationship between initial response to long-term reduction pain.Patients (knee osteoarthritis: N = 43; pain: 41) subdivided based on...
Patients with thrombocytopenia and chronic liver disease are at increased risk of bleeding during invasive procedures due to low platelet counts. Lusutrombopag, an orally active thrombopoietin receptor agonist, increases count reduces the need for transfusion in patients undergoing a planned procedure. The safety lusutrombopag Child–Pugh class C is not known. present analysis was performed determine pharmacokinetics, efficacy, disease. Data were collected from three data sets: phase 1/2...