「臨床試験データの透明性に関するポリシー」制定以降(2018年12月5日以降)にシオノギが承認を取得した製品を対象に、その承認申請で用いられたシオノギの臨床試験の総括報告書の要約を開示します。

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G

一般名 試験No. 試験タイトル

総括報告書の概要

臨床試験

結果の要約

Guanfacine hydrochloride 1506A3112 A Phase 1 Pharmacokinetics Study of Multiple-Doses of S-877503 in Japanese Healthy Adult Subjects

JP

 

 
Guanfacine hydrochloride 1522A3132 Phase III Study of S-877503 in Adult Patients with Attention-deficit/Hyperactivity Disorder JP  
Guanfacine hydrochloride 1523A3133 Phase III Study of S-877503 in Adult Patients with Attention-deficit/Hyperactivity Disorder -long term extension study- JP  

L

一般名 試験No. 試験タイトル 総括報告書の概要

臨床試験

結果の要約

Lisdexamfetamine mesilate 1411A3223 Phase II/III Study of S-877489 in Pediatric Patients with Attention-deficit/Hyperactivity Disorder JP  
Lisdexamfetamine mesilate 1309A3221 Phase II Study of S-877489 in Pediatric Patients with Attention-deficit/Hyperactivity Disorder JP  
Lisdexamfetamine mesilate 1318A3222 Phase II Study of S-877489 in Pediatric Patients with Attention-deficit/Hyperactivity Disorder -Long term Extension Study- JP  
Lisdexamfetamine mesilate 1412A3231 Long-term Study of S-877489 in Pediatric Patients with Attention-deficit/Hyperactivity Disorder JP  
Lusutrombopag 1017M0623 Phase 2 study of S-888711 in thrombocytopenic patients with chronic liver disease

EN

JP

 
Lusutrombopag 1208M0626 Phase 2b study of S-888711 in thrombocytopenic patients with chronic liver disease

EN

JP

 
Lusutrombopag 1304M0631 Phase 3 study of S-888711 in thrombocytopenic patients with chronic liver disease (L-PLUS 1)

EN

JP

 
Lusutrombopag 1338M0633 A Phase 3b Open-label Study of S-888711 in Thrombocytopenic Patients with Chronic Liver Disease EN  
Lusutrombopag 0713M0611

Phase I single-dose, double-blind, placebo-controlled study in healthy adult male subjects to assess the safety and pharmacokinetics of S-88871

1

EN

JP

 
Lusutrombopag 0801M0612 A crossover study to investigate the relative bioavailability and the effect of food on the pharmacokinetics of a single dose of S-888711 in healthy male subjects

EN

JP

 
Lusutrombopag 0806M0613 Phase I multiple-dose, dose-ranging, double-blind, placebo-controlled study to assess the safety and pharmacokinetics of S-888711 in healthy adult male subjects

EN

JP

 
Lusutrombopag 0820M0614 A Pharmacokinetics Study of S-888711 in Caucasian Healthy Adult Male Subjects EN  
Lusutrombopag 0823M0615 A Phase I Multiple-dose, Double-blind Placebo-controlled Study to Assess the Safety and Pharmacokinetics of S-888711 in Healthy Subjects EN  
Lusutrombopag 0911M0616 A Phase 1, Open-Label, Case-Matched Cohort Design, Non-Randomized Pharmacokinetic and Safety Study of a Single Oral Dose of 0.75 mg S-888711 in Healthy Subjects and in Subjects with Mild or Moderate Hepatic Impairment EN  
Lusutrombopag 0912M0617 A Phase 1, Open-label, One-sequence Crossover, Drug-drug Interaction Study to Evaluate the Effect of Repeated Doses of S-888711 on the Pharmacokinetics of the CYP3A4 Substrate, Midazolam, in Healthy Subjects EN  
Lusutrombopag 0924M0618 An Open-label, Randomized, Three-period, Crossover Study to Assess the Effect of Food and Calcium on S-888711 0.25-mg Tablet Pharmacokinetics in Healthy, Adult Volunteer Subjects Following a Single 0.75-mg Oral Dose of S-888711 EN  
Lusutrombopag 1012M0619 A Phase 1 Study to Investigate the Absorption, Distribution, Metabolism, and Excretion of [14C]-S-888711 Following Oral Dose Administration in Healthy Male Subjects EN  
Lusutrombopag 1218M061A A three-way crossover study to assess the relative bioavailability of 1-mg and 4-mg tablets of S-888711 and the effect of high-fat meals on the pharmacokinetics of the 4-mg tablet in healthy male subjects

EN

JP

 
Lusutrombopag 1301M061B Evaluation of platelet functions in thrombocytopenic patients with chronic liver disease treated with S-888711

EN

JP

 
Lusutrombopag 1303M061D A phase 1, randomized, double-blind, placebo- and positive-controlled, 4-period crossover, thorough QT/QTc study of S-888711 in healthy subjects

EN

JP

 
Lusutrombopag 1514M061E A Phase 1, Open-label, Randomized, Three-period Crossover Drug-drug Interaction Study to Evaluate the Effect of Cyclosporine and/or Quinidine Sulfate on the Pharmacokinetics of S-888711 in Healthy Adult Subjects EN  
Lusutrombopag 0913M0621 A multicenter, randomized, double-blind, placebo-controlled, parallel-group study to investigate the efficacy and safety of S-888711 tablets administered once-daily for 42 days to adult subjects with relapsed persistent or chronic immune thrombocytopenia with or without prior splenectomy EN  
Lusutrombopag 0914M0622 An open-label safety study of S-888711 in adult subjects with relapsed persistent or chronic immune thrombocytopenia with or without prior splenectomy EN  
Lusutrombopag 1112M0625 A phase 2 higher-dose study of S-888711 in thrombocytopenic patients with chronic liver disease

EN

JP

 
Lusutrombopag 1525M0627 A Clinical Pharmacology Study of S-888711 in Thrombocytopenic Patients with Child-Pugh Class C Liver Disease EN  
Lusutrombopag 1423M0634 A Phase 3 randomised, double-blind, placebo-controlled study to assess the safety and efficacy of S-888711 (lusutrombopag) for the treatment of thrombocytopenia in patients with chronic liver disease undergoing elective invasive procedures (L-PLUS 2) EN  

N

一般名 試験No. 試験タイトル 総括報告書の概要

臨床試験

結果の要約

Naldemedine 1331V9236 A phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of naldemedine in cancer patients with opioid-induced constipation EN  
Naldemedine 1332V9237 A phase 3, multicenter, open-label study of naldemedine in cancer patients with opioid-induced constipation - extension study - EN  
Naldemedine 1336V9238 A phase 3, open-label study of naldemedine in patients with non-malignant chronic pain and opioid-induced constipation EN  
Naldemedine 0824V9211 Phase 1 single dose clinical study of S-297995 in healthy Japanese adult males

EN

JP

 
Naldemedine 0909V9212 An open-label, crossover study to assess the bioavailability and the food effect on the pharmacokinetics of a single dose of S-297995 in healthy Japanese adult males

EN

JP

 
Naldemedine 0917V9213 Phase I multiple dose clinical study of S-297995 in healthy Japanese adult males

EN

JP

 
Naldemedine 1007V9214 A Randomized, Double-blind, Placebo-controlled, Single-ascending Dose Study to Evaluate the Safety and Efficacy of S-297995 for the Treatment of Opioid-Induced Bowel Dysfunction in Subjects With Chronic Pain EN  
Naldemedine 1016V9215 A Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-S-297995 Following Oral Dose Administration in Healthy Male Subjects EN  
Naldemedine 1101V9216 A Phase 1, Randomized, Double-Blind, Single Dose, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of S-297995 in the Reduction of Opioid-induced Nausea and Emesis in Healthy Subjects EN  
Naldemedine 1202V9218 A Phase 1, Open-label, Randomized, 2-way Crossover Study to Evaluate the Drug-drug Interaction of the P-gp inhibitor Cyclosporine with the Pharmacokinetics of S-297995 in Healthy Adult Subjects EN  
Naldemedine 1204V9219 A Randomized, Double-blind, Placebo- and Positive-controlled, 4-Period, Cross-over Study to Assess the Effect of S-297995 on ECG Parameters in Healthy Volunteers EN  
Naldemedine 1311V921A A Phase 1, Randomized, Open-label, Three-way Crossover Bioavailability Study to Evaluate the S-297995 Phase 3 Tablet Compared with the Phase 2 Tablet and the Food Effect for the Phase 3 S-297995 Tablet in Healthy Adult Subjects  EN  
Naldemedine 1401V921B Phase 1, Open-label, Non-randomized Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Naldemedine in Subjects with Varying Degrees of Renal Impairment and in Matched Control Subjects with Normal Renal Function  EN  
Naldemedine 1402V921C Phase 1, Open-label, Non-randomized, Single-dose, Parallel-group Study to Evaluate the Influence of Mild and Moderate Hepatic Impairment on the Pharmacokinetics and Safety of 0.2 mg Naldemedine Compared with Healthy Demographically-matched Subjects with Normal Hepatic Function EN  
Naldemedine 1403V921D An Open-Label, One-Sequence, Two Period, Crossover, Drug-Drug Interaction Study to Evaluate the Effect of Repeated Administration of Rifampin on the Pharmacokinetics of Naldemedine in Healthy Adult Subjects EN  
Naldemedine 1502V921E An Open-label, One-sequence, Two-period, Crossover, Drug-drug Interaction Study to Evaluate the Effect of Repeated Administration of Itraconazole or Fluconazole on the Pharmacokinetics of Naldemedine in Japanese Healthy Adult Subjects EN  
Naldemedine 1107V9221 A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of S-297995 for the Treatment of Opioid-Induced Constipation in Subjects with Non-Malignant Chronic Pain Receiving Opioid Therapy EN  
Naldemedine 1108V9222 A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of S-297995 for the Treatment of Opioid-induced Constipation (OIC) in Cancer Patients EN  
Naldemedine 1314V9231 A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Naldemedine in the Treatment of Opioid-induced Constipation in Subjects with Non-malignant Chronic Pain Receiving Opioid Therapy EN  
Naldemedine 1315V9232 A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Naldemedine in the Treatment of Opioid-induced Constipation in Subjects with Non-malignant Chronic Pain Receiving Opioid Therapy EN  
Naldemedine 1326V9235 A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Phase 3 Study to Evaluate the Long-term Safety of Naldemedine for the Treatment of Opioid-induced Constipation in Subjects with Non-malignant Chronic Pain Receiving Opioid Therapy EN  
Naldemedine 1339V9239 A phase 3, multicenter, open-label study of naldemedine in patients with non-malignant chronic pain and opioid-induced constipation receiving S-8117 (oxycodone hydrochloride hydrate) EN  

V

一般名 試験№

試験

タイトル

総括報告書の概要

Vyvanse

1411A3223

Phase II/III Study of S-877489 in Pediatric Patients with Attention-deficit/Hyperactivity Disorder

JP

Vyvanse

1309A3221

Phase II Study of S-877489 in Pediatric Patients with Attention-deficit/Hyperactivity Disorder

JP

Vyvanse

1318A3222

Phase II Study of S-877489 in Pediatric Patients with Attention-deficit/Hyperactivity Disorder -Long term Extension Study-

JP

Vyvanse

1412A3231

Long-term Study of S-877489 in Pediatric Patients with Attention-deficit/Hyperactivity Disorder

JP