Registration and Synopses of our Clinical Trials

Shionogi registers and discloses the synopses of our clinical trials through the World Health Organization (WHO) International clinical trials registry platforms in compliance with applicable laws and regulations.

JAPIC

(in Japan)

https://www.clinicaltrials.jp/cti-user/common/Top.jsp

ClinicalTrials.gov

(in the United States)

http://ClinicalTrials.gov

EU Clinical Trial Register

(in Europe)

https://www.clinicaltrialsregister.eu/ctr-search/search

 

 

Clinical Study Reports

We will disclose the clinical study reports synopses which were used in the regulatory new drug approval processes. This applies to the medicinal products that is approved after the day of enactment of “Clinical Trial Data Privacy Policy” (December 5th, 2018).

<Product Generic Name>

A   B   C   D   E   F   G   H   I   J   K   L   M   N   O   P   Q   R   S   T   U   V   W   X   Y   Z

C

Product Generic Name Protocol No. Study title Clinical Study Reports Synopsis
Cefiderocol 1203R2111 A phase 1, randomized, double-blind, single-center, placebo-controlled, ascending single and multiple dose study of S-649266 in healthy adult subjects EN
Cefiderocol 1214R2112 A Phase 1, Single-Center, Open-Label, Intrapulmonary Pharmacokinetics Study after Single Dose of S-649266 in Healthy Adult Subjects EN
Cefiderocol 1222R2113 An Open-label, Non-Randomized Study to Evaluate the Pharmacokinetics, and Safety and Tolerability of S-649266 in Subjects with Varying Degrees of Renal Impairment and in Matched Control Subjects With Normal Renal Function EN
Cefiderocol 1409R2121 A Multicenter, Double-blind, Randomized, Clinical Study to Assess the Efficacy and Safety of Intravenous S-649266 in Complicated Urinary Tract Infections With or Without Pyelonephritis or Acute Uncomplicated Pyelonephritis Caused by Gram-negative Pathogens in Hospitalized Adults in Comparison with Intravenous Imipenem/Cilastatin EN
Cefiderocol 1424R2131 A Multicenter, Randomized, Open-label Clinical Study of S-649266 or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens EN
Cefiderocol 1516R2114 A Study to Characterize Metabolism, Excretion,and Mass Balance of S-649266 after Intravenous Administration of a 1000 mg (100 μCi) Dose of [14C]-S-649266 in Healthy Adult Male Subjects EN
Cefiderocol 1521R2115 A Study to Assess the Effect of S-649266 on the Pharmacokinetics of Furosemide, Metformin, and Rosuvastatin in Healthy Adult Subjects EN
Cefiderocol 1603R2116 A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Tolerability of Single-Ascending Doses of S-649266 (Part 1) and a Randomized, Double-Blind, Placebo- and Positive-Controlled, 4-Period Crossover Study to Assess the Effect of S-649266 on the QT/QTc Interval (Part 2) in Healthy Adult Subjects EN
Cefiderocol 1615R2132 A Multicenter, Randomized, Double-blind, Parallel-group, Clinical Study of S-649266 Compared with Meropenem for the Treatment of Hospital-acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia, or Healthcare-associated Bacterial Pneumonia Caused by Gram-negative Pathogens (APEKS-NP)  EN
Cefiderocol 1713R2117 An Open-label, Multicenter, Single-arm, Phase 1 Study to Assess the Intrapulmonary Concentrations of Cefiderocol at Steady State in Hospitalized Subjects with Known or Suspected Bacterial Pneumonia on Treatment with Standard of Care Antibiotics and Requiring Mechanical Ventilation EN

G

Product Generic Name Protocol No. Study title Clinical Study Reports Synopsis
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

Product Generic Name Protocol No. Study title Clinical Study Reports Synopsis
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-888711

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

Product Generic Name Protocol No. Study title Clinical Study Reports Synopsis
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