Clinical trials: sponsored by Shionogi
Type 2 Diabetes Mellitus
Study to Assess Safety and Pharmacokinetics of Double-Blind S-707106 Alone and in Combination With Open-Label Metformin in Patients With Type 2 Diabetes Mellitus
The purpose of this study is to determine the safety and pharmacokinetics of double-blind S-707106 alone and in combination with open-label metformin in patients with type 2 diabetes mellitus
- Trial name
- NCT01154348
- Testing
- S-707106, Metformin, S-707106 plus metformin
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Shionogi
Solid Tumors
A Phase 1 Study of S-3304 in Patients With Solid Tumors
To determine the maximum tolerated dose and safety profile of S-3304 in patients with biopsy accessible cancer who have failed previous therapy or to whom no standard therapies are available.
- Trial name
- NCT00033215
- Testing
- S-3304
- Where
- 4 sites in United States
- Volunteers
- 32 people
- Sponsor
- Shionogi
Combined Hyperlipidemia
A Study to Evaluate Daily Pravastatin, Fenofibrate or Pravafen in the Treatment of Combined Hyperlipidemia
This is a multi-center, double blind, prospective, longitudinal, randomized, 12-week study with a 52-week open-label follow-up to evaluate the safety and efficacy of daily administration of Pravastatin 40 mg or Fenofibrate 160 mg…
- Trial name
- NCT00459745
- Testing
- Pravafen, Pravastatin, Fenofibrate
- Where
- 57 sites in United States
- Volunteers
- 481 people
- Sponsor
- Shionogi
Opioid-induced Constipation
Long Term Safety of Naldemedine
The purpose of this study is to evaluate the long-term safety of naldemedine for the treatment of constipation due to opioid therapy.
- Trial name
- NCT01965652
- Testing
- Naldemedine
- Where
- 186 sites in United States, Australia and 14 more
- Volunteers
- 1,246 people
- Sponsor
- Shionogi
Attention Deficit Hyperactivity Disorder
Open-Label, Chronic Exposure, Safety Study of CLONICEL (Clonidine HCl Sustained Release) in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
The purpose of this 12-month, multi-center, open-label study is to evaluate the safety of CLONICEL (clonidine HCl sustained release) when administered chronically under regular clinical conditions either as monotherapy or in…
- Trial name
- NCT00723190
- Testing
- CLONICEL (Clonidine HCl sustained release)
- Where
- 27 sites in United States
- Volunteers
- 303 people
- Sponsor
- Shionogi
Plaque Psoriasis, Psoriasis
Study to Evaluate Safety,Tolerability,Pharmacodynamics & Pharmacokinetics of JTE-451 in Active Plaque Psoriasis Subjects
Study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effect of JTE-451 administered for 4 weeks in subjects with active plaque psoriasis.
- Conditions
- Plaque Psoriasis, Psoriasis, Skin Diseases
- Trial name
- NCT03018509
- Testing
- JTE-451
- Where
- 5 sites in Canada
- Volunteers
- 47 people
- Sponsor
- Shionogi Inc.
Opioid-induced Constipation
A Study of Naldemedine (S-297995) for the Treatment of Opioid-Induced Constipation in Adults With Non-Malignant Chronic Pain Receiving Opioid Therapy
The purpose of this study is to determine efficacy and safety of naldemedine for the treatment of opioid-induced constipation in adults with non-malignant chronic pain receiving opioid therapy for ≥ 3 months.
- Trial name
- NCT01443403
- Testing
- Naldemedine
- Where
- 49 sites in United States
- Volunteers
- 244 people
- Sponsor
- Shionogi
Opioid-induced Constipation
Efficacy and Safety of Naldemedine in Treating Opioid-induced Constipation
The purpose of this study is to evaluate the efficacy and safety of naldemedine in the treatment of opioid-induced constipation (OIC) in adults with non-malignant chronic pain who are not using laxatives.
- Trial name
- NCT01993940
- Testing
- Naldemedine
- Where
- 49 sites in United States
- Volunteers
- 553 people
- Sponsor
- Shionogi
Opioid Induced Bowel Dysfunction
Study to Evaluate the Safety and Efficacy of Naldemedine (S-297995) for the Treatment of Opioid-Induced Bowel Dysfunction in Subjects With Chronic Pain
The primary objective of the study is to evaluate the safety of single doses of oral naldemedine in adults physically dependent on opioids.
- Trial name
- NCT01122030
- Testing
- Naldemedine
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- Shionogi
Opioid-induced Constipation
Efficacy and Safety of Naldemedine in the Treatment of Opioid-induced Constipation
The purpose of this study is to evaluate the efficacy and safety of naldemedine in the treatment of opioid-induced constipation (OIC) in adults with non-malignant chronic pain who are not using laxatives.
- Trial name
- NCT01965158
- Testing
- Naldemedine
- Where
- 65 sites in United States, Austria and 5 more
- Volunteers
- 547 people
- Sponsor
- Shionogi
Anemia of Chronic Kidney Disease
Mass Balance Study of JTZ-951 in Subjects With End-stage Renal Disease on Hemodialysis
A mass balance study to determine the routes and rates of elimination of radioactivity, to determine total radioactivity in plasma and whole blood over time and compare levels to JTZ-951 and drug-derived entities in plasma and to…
- Trial name
- NCT02805244
- Testing
- JTZ-951, 14C-JTZ-951
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Shionogi Inc.
Anemia of Chronic Kidney Disease
Study to Evaluate Effect of Lapatinib on Pharmacokinetics of JTZ-951 in Subjects With End-stage Renal Disease
Study to evaluate the effect of lapatinib, a breast cancer resistance protein (BCRP) inhibitor, on the pharmacokinetics (PK) of JTZ-951 and to evaluate the safety and tolerability of JTZ-951 when administered alone and one hour…
- Trial name
- NCT02581124
- Testing
- JTZ-951, Lapatinib
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Shionogi Inc.
Diabetes Mellitus
Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Doses of JTT-252
The purpose of this study is to evaluate the safety, tolerability, and PK of single oral doses of JTT-252 and the effect of food on the PK of JTT-252 in healthy subjects, and to evaluate the safety, tolerability, PK and PD of…
- Trial name
- NCT02120976
- Testing
- JTT-252
- Where
- 2 sites in United States
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- Shionogi Inc.
Diabetes Mellitus
Study of Safety, Tolerability and Pharmacokinetics of Single Oral JTT-251 Doses in Healthy and Type 2 Diabetic Subjects
The purpose of this study is to evaluate the safety, tolerability, and PK (Pharmacokinetics) of single oral doses of JTT-251 in healthy and type 2 diabetes mellitus subjects and to evaluate the effect of food on the PK of JTT-251…
- Trial name
- NCT02106585
- Where
- United States
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Shionogi Inc.
Anemia of Chronic Kidney Disease
Safety, Tolerability, PK & PD Study of JTZ-951 in Anemic Subjects With End-stage Renal Disease
The purpose of this study is to determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of sequential ascending doses of JTZ-951 administered for 15 days in anemic subjects with end-stage renal…
- Trial name
- NCT01971164
- Testing
- JTZ-951
- Where
- 5 sites in United States
- Volunteers
- 29 people
- Sponsor
- Shionogi Inc.
Anemia in Chronic Kidney Disease
Effect of Hemodialysis on the PK of JTZ-951 in Subjects With End-stage Renal Disease
The purpose of this study is to evaluate the effect of hemodialysis on the pharmacokinetics (PK) of JTZ-951 and to evaluate the safety of 2 doses of JTZ-951 in subjects with end-stage renal disease (ESRD) receiving hemodialysis
- Trial name
- NCT01978587
- Testing
- JTZ-951
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Shionogi Inc.
Type 2 Diabetes Mellitus
Safety and Efficacy Study of JTT-851 in Patients With Type 2 Diabetes Mellitus
The purpose of this study is to evaluate the effect of JTT-851 on diabetes as well as to assess the safety, tolerability, and pharmacokinetics of JTT-851 in type 2 diabetic patients either treated with metformin or…
- Trial name
- NCT01699737
- Testing
- JTT-851, Glimepiride
- Where
- 79 sites in United States
- Volunteers
- 325 people
- Sponsor
- Shionogi Inc.
Atrophy, Vaginal Diseases
A Clinical Study to Evaluate Ospemifene in the Treatment of Vulvar and Vaginal Atrophy in Postmenopausal Women
The purpose of this study is to determine whether ospemifene is more effective than placebo in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women.
- Trial name
- NCT00276094
- Testing
- Ospemifene 30 mg, Ospemifene 60 mg, Nonhormonal vaginal lubricant
- Volunteers
- 826 people
- Sponsor
- Shionogi
Atrophy, Vaginal Diseases
A Clinical Study to Evaluate the Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women
The purpose of the study is to assess the efficacy, safety and tolerability of Ospemifene 5 mg, 15 mg, and 30 mg in the treatment of VVA in postmenopausal women to find the minimum effective dose below the lowest dose of 30 mg…
- Trial name
- NCT00630539
- Testing
- Ospemifene 5 mg, Ospemifene 15 mg, Ospemifene 30 mg
- Volunteers
- 126 people
- Sponsor
- Shionogi
Dyslipidemia
Efficacy and Safety Study of JTT-302 in Subjects With Low HDL-C Levels
The purpose of this study is to determine the effect of JTT-302 on the increase of High Density Lipoprotein-Cholesterol (HDL-C) levels when administered daily for four weeks in subjects with low HDL-C levels.
- Trial name
- NCT00749788
- Testing
- JTT-302
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Shionogi Inc.