Clinical trials: sponsored by Shionogi
Urinary Tract Infections
A Study of Efficacy and Safety of Intravenous Cefiderocol (S-649266) Versus Imipenem/Cilastatin in Complicated Urinary Tract Infections
The purpose of this study was to determine the efficacy and safety of intravenous cefiderocol (S-649266) in hospitalized adults with complicated urinary tract infections caused by Gram-negative pathogens.
- Trial name
- APEKS-cUTI (NCT02321800)
- Testing
- Cefiderocol, Imipenem/cilastatin
- Volunteers
- 452 people
- Sponsor
- Shionogi
Influenza
Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Patients With Influenza at High Risk of Influenza Complications
The primary objective of this study is to evaluate the efficacy of a single, oral dose of baloxavir marboxil compared with placebo by measuring the time to improvement of influenza symptoms in patients with influenza presenting…
- Trial name
- CAPSTONE 2 (NCT02949011)
- Testing
- Baloxavir Marboxil, Oseltamivir
- Volunteers
- 2,184 people
- Sponsor
- Shionogi
Influenza
A Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Otherwise Healthy Patients With Influenza
The primary objective of this study is to evaluate the efficacy of a single, oral dose of baloxavir marboxil compared with placebo by measuring the time to alleviation of symptoms in patients with uncomplicated influenza virus…
- Trial name
- CAPSTONE 1 (NCT02954354)
- Testing
- Baloxavir Marboxil, Oseltamivir
- Volunteers
- 1,436 people
- Sponsor
- Shionogi
Pulmonary Arterial Hypertension
Study to Evaluate Efficacy and Safety of JTT-251 in Participants With Pulmonary Arterial Hypertension
Study to evaluate the efficacy, safety, tolerability and pharmacokinetics of JTT-251 administered for 24 weeks in participants with pulmonary arterial hypertension (PAH)
- Trial name
- RELIEF-PAH (NCT03789643)
- Testing
- JTT-251
- Sponsor
- Shionogi Inc.
Vaginal Dryness
Study to Evaluate Ospemifene in Patients With Moderate to Severe Vaginal Dryness Due to Menopause
The objective of this study is to evaluate the efficacy and safety of ospemifene 60 mg once daily (QD) compared with placebo in treatment of vulvo-vaginal atrophy (VVA) due to menopause in women with moderate to severe vaginal…
- Trial name
- NCT02638337
- Testing
- Ospemifene
- Volunteers
- 631 people
- Sponsor
- Shionogi
Healthy Volunteer
Effect of Food and Calcium on Pharmacokinetics of a Single Dose of S-888711 in Healthy Adult Volunteers
The primary objectives of this study were: To assess the effect of a high-fat diet on the pharmacokinetics (PK) of a 0.75 mg single dose of S-888711 orally administered as 0.25 mg tablets in healthy volunteer adults To assess the…
- Trial name
- NCT03897413
- Testing
- S-888711, Calcium Antacid
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Shionogi
Chronic Liver Disease, Thrombocytopenia
Safety and Efficacy Study of Lusutrombopag for Thrombocytopenia in Patients With Chronic Liver Disease Undergoing Elective Invasive Procedures
The primary purpose of this study is to compare the efficacy of lusutrombopag with placebo for the treatment of thrombocytopenia in patients with chronic liver disease who are undergoing elective invasive procedures.
- Trial name
- L-PLUS 2 (NCT02389621)
- Testing
- Lusutrombopag
- Volunteers
- 215 people
- Sponsor
- Shionogi
Atrophy, Vaginal Diseases
Long-Term Safety of Ospemifene 60 mg Oral Daily Dose for the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women Without a Uterus
The objective of the study was to assess the long-term safety of daily doses of ospemifene 60 mg in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women without a uterus.
- Trial name
- NCT01586364
- Testing
- Ospemifene 60Mg Oral Tablet
- Volunteers
- 301 people
- Sponsor
- Shionogi
Atrophy, Vaginal Diseases
Long-Term Safety of 30 mg and 60 mg Oral Daily Dose of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women With Intact Uterus
The primary objective of the study was to assess the long-term safety of 30- and 60-mg daily doses of ospemifene in the treatment of Vulvar and Vaginal Atrophy (VVA) in postmenopausal women with an intact uterus.
- Trial name
- NCT01585558
- Testing
- Ospemifene (Dose 1), Ospemifene (Dose 2)
- Volunteers
- 180 people
- Sponsor
- Shionogi
Atrophy, Vaginal Diseases
Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity
The purpose of this study is to determine the safety and efficacy of ospemifene in postmenopausal women experiencing moderate to severe vaginal dryness and vaginal pain associated with sexual activity.
- Trial name
- NCT00729469
- Testing
- Ospemifene 60 mg
- Volunteers
- 919 people
- Sponsor
- Shionogi
Atrophy, Vaginal Diseases
A Clinical Study to Evaluate the Safety of Ospemifene
The purpose of this study is to determine the efficacy and long-term safety of 60mg ospemifene in the treatment of VVA in postmenopausal women with intact uterus.
- Trial name
- NCT00566982
- Testing
- Ospemifene 60 mg
- Volunteers
- 426 people
- Sponsor
- Shionogi
Type 2 Diabetes Mellitus
Safety and Efficacy of S-707106 in Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control With Metformin Therapy
The purpose of this study is to evaluate the safety and efficacy of S-707106 co-administered with metformin in subjects with type 2 diabetes mellitus.
- Trial name
- NCT01240759
- Testing
- S-707106 Dose A, S-707106 Dose B, S-707106 Dose C
- Where
- United States
- Volunteers
- 218 people
- Sponsor
- Shionogi
Obesity
Phase IIb One Year Efficacy and Safety Study of S-2367 in Obese Subjects With Reduced Calorie Diet
1. To evaluate the effect of S-2367 on body weight when administered following a 6-week placebo lead-in period and then a 54-week 800 kilocalorie deficit reduced calorie diet compared to placebo in healthy obese male and female…
- Trial name
- NCT00747929
- Testing
- S-2367 800 mg, S-2367 1600 mg, Reduced Calorie Diet
- Where
- 38 sites in United States
- Volunteers
- 724 people, healthy volunteers welcome
- Sponsor
- Shionogi
Obesity
Phase IIb One Year Efficacy and Safety Study of S-2367 in Obese Subjects With Initial 6-Week Low Calorie Diet
1. To evaluate the weight loss effect of 1600 mg/day S-2367 administered orally once daily with the morning meal after a 6-week low calorie diet (LCD) of 950 kcal/day with or without S-2367 followed by 54 weeks while on a 800…
- Trial name
- NCT00748605
- Testing
- S-2367 1600 mg q.d. 54 Weeks, S-2367 1600 mg q.d. 60 weeks, LCD (low calorie diet)
- Where
- 40 sites in United States
- Volunteers
- 842 people, healthy volunteers welcome
- Sponsor
- Shionogi
Obesity
Double-Blind, Multi-Center, Randomized Study to Assess the Efficacy and Safety of Velneperit (S-2367) and Orlistat Administered Individually or Combined With a Reduced Calorie Diet (RCD) in Obese Subjects
To evaluate the weight loss effect and safety of 400 mg velneperit and 120 mg orlistat administered individually or combined three times per day for 24 weeks while on a reduced calorie diet (RCD) and also to evaluate the…
- Trial name
- NCT01126970
- Testing
- Velneperit 400 mg, Orlistat 120 mg, Reduced Calorie Diet
- Where
- 25 sites in United States
- Volunteers
- 486 people
- Sponsor
- Shionogi
Atopic Dermatitis
A Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of 2 Doses of S-777469 in Patients With Atopic Dermatitis
The purpose of this study is to evaluate the safety and efficacy of 2 doses of S-777469 in patients with atopic dermatitis.
- Trial name
- NCT00703573
- Testing
- S-777469 400 mg, S-777469 800 mg
- Where
- 33 sites in United States
- Volunteers
- 209 people
- Sponsor
- Shionogi
Non Small Cell Lung Cancer, Lung Cancer
Study of S-3304 in Patients With Locally Advanced Non-Small Cell Lung Cancer
A study to measure the safety and effectiveness of S-3304 when given in combination with conventional chemo-radiation therapy in patients with locally advanced non-small cell lung cancer.
- Conditions
- Non Small Cell Lung Cancer, Lung Cancer, Stage IIIA Non Small Cell Lung Cancer, Stage IIIB Non Small Cell Lung Cancer
- Trial name
- NCT00078390
- Testing
- S-3304, Chemo-irradiation
- Where
- 5 sites in United States
- Volunteers
- 9 people
- Sponsor
- Shionogi
Atopic Dermatitis
A Phase Ib/IIa, Double-Blind, Randomized Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of S-777469 in Subjects With Atopic Dermatitis
The purpose of this randomized, double-blind, placebo-controlled, sequential-cohort, dose-escalation study was to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of S-777469, a CB2 cannabinoid receptor…
- Trial name
- NCT00697710
- Testing
- 50 mg S-777469, 200 mg S-777469, 800 mg S-777469
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- Shionogi
Obesity
Open-Label Extension (OLE) Study for Safety and Efficacy of Velneperit (S-2367) in Obese Subjects
The purpose of this open-label extension study is to evaluate the safety and efficacy of velneperit (S-2367) in obese subjects.
- Trial name
- OLE (NCT00788528)
- Testing
- S-2367 (velneperit)
- Where
- 73 sites in United States
- Volunteers
- 766 people, healthy volunteers welcome
- Sponsor
- Shionogi
Seasonal Allergic Rhinitis
Combination Study Of S-555739/Cetirizine HCl In Adult Patients With Seasonal Allergic Rhinitis
The primary objective of the study was to examine the efficacy and safety of S-555739/cetirizine HCl compared with the individual components and placebo.
- Trial name
- NCT01651871
- Testing
- S-555739 Dose 1, S-555739 Dose 2, Cetirizine HCl Dose 1
- Volunteers
- 779 people
- Sponsor
- Shionogi