Clinical trials: sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.
Stress Disorders, Post-Traumatic
A Study of Flexible Dose Brexpiprazole as Monotherapy or Combination Therapy in the Treatment of Adults With Post-traumatic Stress Disorder (PTSD)
To evaluate the safety, efficacy and tolerability of brexpiprazole (with placebo) as monotherapy or combination therapy with Zoloft (sertraline) in adults with PTSD.
- Trial name
- NCT03033069
- Testing
- Brexpiprazole, Sertraline
- Where
- 54 sites in United States
- Volunteers
- 336 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Tuberculosis, Pulmonary, Tuberculosis, Multidrug Resistant
A Trial to Evaluate OPC 67683 in Participants With Pulmonary Sputum Culture-positive, Multidrug-resistant Tuberculosis (TB)
This is a clinical trial to evaluate the safety and efficacy of OPC-67683 in the treatment of multidrug resistant tuberculosis (MDR TB) for 56 days.
- Conditions
- Tuberculosis, Pulmonary, Tuberculosis, Multidrug Resistant, Extensively Drug-Resistant Tuberculosis
- Trial name
- NCT00685360
- Testing
- Delamanid, Optimized Background Regimen (OBR)
- Where
- 17 sites in United States, China and 7 more
- Volunteers
- 481 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Atopic Dermatitis
A Study to Evaluate the Effectiveness and Safety of Topical OPA-15406 Ointment to Treat Participants With Atopic Dermatitis
The purpose of this study is to investigate the effectiveness and safety of 2 concentrations of OPA-15406 compared to vehicle in participants with atopic dermatitis (AD).
- Trial name
- NCT02068352
- Testing
- OPA-15406, Vehicle ointment
- Where
- 30 sites in United States, Australia and 1 more
- Volunteers
- 121 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Attention Deficit Disorder With Hyperactivity
Safety and Efficacy Study of Centanafadine Sustained-Release (CTN SR) in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)
This was a Phase 2b, randomized, double-blind, multicenter, 2-period, 2-treatment, crossover study to evaluate safety and efficacy of CTN SR compared with placebo in adults with ADHD.
- Trial name
- NCT02547428
- Testing
- CTN SR
- Where
- 4 sites in United States
- Volunteers
- 85 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Tuberculosis
Safety and Pharmacokinetics (PK) in Multidrug-Resistant (MDR) Refractive Tuberculosis
The purpose of this study is: To evaluate the safety and tolerability of orally administered OPC-67683 when administered two times daily to MDR tuberculosis (TB) participants refractory to treatment with an optimized background…
- Trial name
- NCT01131351
- Testing
- Delamanid, Optimized Background Regimen (OBR)
- Where
- 3 sites in Latvia, Lithuania
- Volunteers
- 10 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Tuberculosis, Multidrug-Resistant
A Trial to Evaluate Safety, Tolerability, and Efficacy of Orally Administered OPC-67683
A phase 2, multicenter, uncontrolled, open-label trial in participants with Multi-drug Resistant Tuberculosis (MDR-TB). Only participants who completed Trial 242-07-204 (NCT00685360) were eligible.
- Trial name
- NCT02573350
- Testing
- Delamanid, OBR
- Where
- 8 sites in China, Estonia and 4 more
- Volunteers
- 213 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Adult Attention Deficit Hyperactivity Disorder
The Safety and Efficacy of OPC-64005 in the Treatment of Adult Attention-deficit/Hyperactivity Disorder
A trial to assess the safety and efficacy of OPC-64005 in the treatment of adult attention-deficit/hyperactivity disorder.
- Trial name
- NCT03324581
- Testing
- OPC-64005, Atomoxetine
- Where
- 26 sites in United States
- Volunteers
- 239 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Device Latency
Substudy of the Accuracy of Ingestible Event Marker (IEM) Detection by the Medical Information Device #1 (MIND1)
The purpose of this study was to determine the accuracy of IEM detection by the MIND1 System by completing a series of Patch applications and IEM ingestions in the clinic.
- Trial name
- OSMITTER (NCT02091882)
- Testing
- Combination product of Aripiprazole + IEM + Sensor + MIND1 Application
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Major Depressive Disorder (MDD)
Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD)
This will be a multicenter, randomized, double-blind study designed to assess the efficacy, safety and tolerability of an oral Aripiprazole/Escitalopram combination therapy in participants with MDD who have demonstrated an…
- Trial name
- NCT01111552
- Testing
- Escitalopram, Aripiprazole
- Where
- 60 sites in United States, Australia and 5 more
- Volunteers
- 237 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Tolvaptan Extension Study in Participants With ADPKD
To demonstrate whether tolvaptan modifies ADPKD progression as measured by changes from Baseline (from Study 156-04-251) in total kidney volume (TKV) and renal function.
- Trial name
- TEMPO 4/4 (NCT01214421)
- Testing
- Tolvaptan
- Where
- 97 sites in United States, Argentina and 11 more
- Volunteers
- 1,083 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Major Depressive Disorder (MDD)
Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD)
This will be a multicenter, randomized, double-blind study designed to assess the efficacy, safety and tolerability of an oral Aripiprazole/Escitalopram combination therapy in participants with MDD who have demonstrated an…
- Trial name
- NCT01111539
- Testing
- Escitalopram, Aripiprazole, Blinded capsule
- Where
- 62 sites in United States, Estonia and 7 more
- Volunteers
- 211 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Attention Deficit Disorder, Attention Deficit Hyperactivity Disorder
A Trial to Evaluate the Efficacy, Safety, and Tolerability of Centanafadine Sustained-release Tablets in Adults With Attention-deficit/Hyperactivity Disorder
This study evaluated the efficacy, safety, and tolerability of centanafadine sustained-release tablets in adults with ADHD. Participants either received a twice-daily dose of centanafadine sustained-release tablets, or…
- Trial name
- NCT03605836
- Testing
- Centanafadine SR
- Where
- United States
- Volunteers
- 590 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Tourette's Disorder
Efficacy & Safety Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder (TD)
The goal of the current trial is to determine efficacy and safety of once-weekly aripiprazole in reducing Total Tic Severity (TTS) score in children and adolescents with Tourette's Disorder.
- Trial name
- NCT01418352
- Testing
- Aripiprazole
- Where
- 35 sites in United States, Bulgaria and 3 more
- Volunteers
- 83 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Tourette's Disorder
Efficacy & Safety Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder
The goal of the current study is to determine efficacy and safety of once-weekly aripiprazole in reducing Total Tic Severity (TTS) score in children and adolescents with Tourette's Disorder.
- Trial name
- NCT01418339
- Testing
- Aripiprazole
- Where
- 39 sites in United States, Canada and 4 more
- Volunteers
- 135 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Tourette's Disorder
Safety and Tolerability Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder
The goal of the current trial is to obtain long term efficacy, safety and tolerability data of once weekly aripiprazole in children and adolescents with Tourette's Disorder.
- Trial name
- NCT01416441
- Testing
- Aripiprazole
- Where
- 80 sites in United States, Bulgaria and 8 more
- Volunteers
- 170 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia
A Trial in Adult Participants With Schizophrenia Treated Prospectively for 6-months With Abilify MyCite®
To compare inpatient psychiatric hospitalization rates while participants are on oral standard-of-care antipsychotic treatment and later switched to Abilify MyCite®.
- Trial name
- NCT03892889
- Testing
- Abilify MyCite®
- Where
- 68 sites in United States
- Volunteers
- 277 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Crohn's Disease
Efficacy and Safety of Oral OPS-2071 in Participants With Crohn's Disease Showing Symptoms of Active Inflammation
The purpose of this study is to evaluate the effects and safety of OPS-2071 (150, 300, or 600 mg twice a day [BID]) versus placebo, as add-on therapy in participants with Crohn's disease who show symptoms of active inflammation…
- Trial name
- NCT03850509
- Testing
- OPS-2071
- Where
- 31 sites in United States, Poland
- Volunteers
- 3 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Tourette's Disorder (TD)
Trial to Evaluate the Long-term Efficacy of Oral Aripiprazole in the Treatment of Pediatric Participants With Tourette's Disorder
To evaluate the long-term efficacy of oral aripiprazole in pediatric participants for the treatment of Tourette's Disorder (TD).
- Trial name
- NCT03661983
- Testing
- Aripiprazole
- Where
- 42 sites in United States, Canada and 1 more
- Volunteers
- 36 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Agitation Associated With, Alzheimer's Disease
A Phase 3, 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of 2 Fixed Doses of Brexpiprazole in the Treatment of Alzheimer's Agitation
To compare the efficacy of 2 fixed doses of brexpiprazole with placebo in participants with agitation associated with dementia of the Alzheimer's type.
- Conditions
- Agitation Associated With, Alzheimer's Disease, Alzheimer's Type, Mental Disorder
- Trial name
- NCT01862640
- Testing
- Brexpiprazole, OPC-34712
- Where
- 85 sites in United States, Croatia and 5 more
- Volunteers
- 433 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Multidrug Resistant Tuberculosis
A 6-Month Safety, Efficacy, and Pharmacokinetic (PK) Trial of Delamanid in Pediatric Participants With Multidrug Resistant Tuberculosis (MDR-TB)
The purpose of this trial is to assess the safety, tolerability, pharmacokinetics, and efficacy of long-term (6-month) treatment with delamanid plus an optimized background regimen (OBR) of other anti-tuberculosis drugs in…
- Trial name
- NCT01859923
- Testing
- Delamanid, Delamanid Pediatric Formulation (DPF), Optimized Background Regimen (OBR)
- Where
- 3 sites in Philippines, South Africa
- Volunteers
- 37 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.