Clinical trials: sponsored by Shionogi
SARS-CoV-2
A Study of Secutrelvir in Participants With Coronavirus Disease 2019 (COVID-19) Who Are at High Risk for Progression to Severe Disease
The primary purpose of this study is to evaluate the efficacy and safety of secutrelvir in symptomatic nonhospitalized adult and adolescent participants with COVID-19 who are at high risk for progression to severe disease.
- Trial name
- NCT07743580
- Testing
- Secutrelvir
- Where
- 51 sites in United States, Bulgaria and 1 more
- Volunteers
- 2,000 people
- Sponsor
- Shionogi
SARS-CoV-2 Infection
Phase 3 Study of S-217622 in Prevention of Symptomatic SARS-CoV-2 Infection
The purpose of this study is to measure the proportion of participants who are infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (positive reverse transcription polymerase chain reaction [RT-PCR] test)…
- Trial name
- SCORPIO-PEP (NCT05897541)
- Testing
- S-217622
- Where
- 178 sites in United States, Argentina and 3 more
- Volunteers
- 3,701 people, healthy volunteers welcome
- Sponsor
- Shionogi
COVID-19
Study of Secutrelvir in Participants With COVID-19
The main purpose of this study is to compare secutrelvir to placebo with respect to resolution of clinical symptoms in nonhospitalized participants with Coronavirus Disease 2019 (COVID-19) starting intervention within 48 hours of…
- Trial name
- NCT07746544
- Testing
- Secutrelvir
- Where
- Japan
- Volunteers
- 1,200 people
- Sponsor
- Shionogi
Opioid-Induced Constipation (OIC)
Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids
The primary objective of this study is to evaluate the pharmacokinetic (PK) profile of naldemedine and nor-naldemedine after a single oral dose of naldemedine in pediatric participants who are receiving or about to receive…
- Trial name
- NCT05588323
- Testing
- Naldemedine
- Where
- 16 sites in Albania, Armenia and 6 more
- Volunteers
- 24 people
- Sponsor
- Shionogi
Jordan's Syndrome, PPP2R5D Neurodevelopmental Disorder
Study of Zatolmilast (BPN14770) in Participants With PPP2R5D Neurodevelopmental Disorder (Jordan's Syndrome [JS])
The primary objective of this study is to assess the efficacy, safety, and tolerability of BPN14770 in participants aged 9 to 45 years with JS.
- Trial name
- NCT06717438
- Testing
- BPN14770
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Shionogi
Gram-Negative Bacterial Infections
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Neonates and Infants
The primary purpose of this study is to understand the pharmacokinetics (PK) of single and multiple doses of cefiderocol in children from birth to less than 3 months of age with suspected or confirmed aerobic Gram-negative…
- Trial name
- NCT06086626
- Testing
- Cefiderocol, Standard of Care
- Where
- 4 sites in United States, South Africa and 1 more
- Volunteers
- 30 people
- Sponsor
- Shionogi
Gram-negative Bacterial Infections, Bloodstream Infections (BSI)
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Cefiderocol in Hospitalized Pediatric Participants
The primary objectives of this study are: To assess the safety and tolerability of cefiderocol after single-dose administration in hospitalized paediatric participants 3 months to < 18 years of age with suspected or confirmed…
- Conditions
- Gram-negative Bacterial Infections, Bloodstream Infections (BSI), Complicated Intra-abdominal Infection (cIAI), Hospital Acquired Pneumonia (HAP)
- Trial name
- NCT04335539
- Testing
- Cefiderocol, Standard of Care
- Where
- 23 sites in Belgium, Estonia and 7 more
- Volunteers
- 53 people
- Sponsor
- Shionogi
Gram-negative Bacterial Infections, Hospital Acquired Bacterial Pneumonia (HABP)
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Pediatric Participants
The primary objectives of this study are to assess the safety, tolerability, and pharmacokinetics (PK) of cefiderocol after single-dose administration in hospitalized pediatric participants 3 months to < 12 years of age with…
- Conditions
- Gram-negative Bacterial Infections, Hospital Acquired Bacterial Pneumonia (HABP), Complicated Urinary Tract Infection (cUTI), Ventilator Associated Bacterial Pneumonia (VABP)
- Trial name
- NCT04215991
- Testing
- Cefiderocol, Standard of Care
- Where
- 25 sites in United States, Australia and 8 more
- Volunteers
- 91 people
- Sponsor
- Shionogi
RSV Infections
A Study to Investigate How Respiratory Syncytial Virus (RSV) Infection Develops and Changes Over Time in Pediatric Participants
The primary purpose of this study is to observe how viral load and titer change over time in participants with RSV and how data from hospitalized participants compares with data from non-hospitalized participants.
- Trial name
- NCT06746051
- Where
- 2 sites in United States
- Volunteers
- 100 people
- Sponsor
- Shionogi
Vulvovaginal Atrophy
Women's Satisfaction and Adherence to Vulvovaginal Atrophy Treatments
The primary objective of this study is to describe and assess participants' satisfaction with current vulvovaginal atrophy (VVA) treatment.
- Trial name
- CRETA (NCT04607707)
- Where
- 3 sites in Spain
- Volunteers
- 831 people
- Sponsor
- Shionogi
Depressive Disorder
A Study of Duloxetine (LY248686) in the Treatment of Japanese Children and Adolescents With Depressive Disorder
The purpose of this long-term study is to evaluate the safety and efficacy of duloxetine hydrochloride in Japanese children and adolescents with depressive disorder.
- Trial name
- NCT03395353
- Testing
- Duloxetine Hydrochloride
- Where
- Japan
- Volunteers
- 151 people
- Sponsor
- Shionogi
Depressive Disorder
A Study of Duloxetine (LY248686) in Japanese Children and Adolescents With Depressive Disorder
The purpose of this study is to determine the efficacy of duloxetine hydrochloride versus placebo in the treatment of Japanese children and adolescents with depressive disorder.
- Trial name
- NCT03315793
- Testing
- Duloxetine Hydrochloride
- Where
- Japan
- Volunteers
- 149 people
- Sponsor
- Shionogi
Bacterial Infections
Expanded Access to Cefiderocol for the Intravenous Treatment of Severe Gram Negative Bacterial Infections
Expanded access may be provided for cefiderocol for qualified patients who have limited treatment options and are not eligible for a clinical trial.
- Trial name
- NCT03780140
- Testing
- Cefiderocol
- 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
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
Cerebral Palsy, Neurological Conditions
Safety and Efficacy Study of Oral Glycopyrrolate Liquid for the Treatment of Pathologic (Chronic Moderate to Severe) Drooling in Pediatric Patients 3 to 18 Years of Age With Cerebral Palsy or Other Neurologic Conditions
This is an open-label clinical research study of an oral glycopyrrolate liquid for the treatment of chronic moderate to severe drooling in patients with cerebral palsy or other neurological conditions.
- Conditions
- Cerebral Palsy, Neurological Conditions, Mental Retardation, Sialorrhea
- Trial name
- NCT00491894
- Testing
- Oral Glycopyrrolate Liquid
- Where
- 7 sites in United States
- Volunteers
- 137 people
- Sponsor
- Shionogi