Clinical trials: sponsored by 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
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
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
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
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 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
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
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
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
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
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
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
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 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