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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-142635 | Other Identifier | Japic |
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To assess the pharmacokinetics and safety of aripiprazole intra-muscular (IM) depot formulation in patients with schizophrenia after repeated administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug: OPC-14597 IMD | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPC-14597 IMD | Drug | Administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals |
|
| Measure | Description | Time Frame |
|---|---|---|
| OPC-14597 Plasma Concentration 672 Hours Postdose Following Multiple Administration of OPC-14597 IMD Injections | 672 hours postdose of the first, second, third, fourth, and fifth IMD injections |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jun-ichi Hashimoto, PhD | Otsuka Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chugoku Region | Japan | |||||
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| ID | Title | Description |
|---|---|---|
| FG000 | OPC-14597 IMD | Administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Hokkaido Region |
| Japan |
| Kanto Region | Japan |
| Kinki Region | Japan |
| Kyushu Region | Japan |
| COMPLETED |
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| NOT COMPLETED |
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Safety analysis set included subjects who received aripiprazole IMD at least once and who had safety data after aripiprazole IMD administrationn.
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| ID | Title | Description |
|---|---|---|
| BG000 | OPC-14597 IMD | Administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | OPC-14597 Plasma Concentration 672 Hours Postdose Following Multiple Administration of OPC-14597 IMD Injections | Pharmacokinetic analysis set included subjects whose plasma concentrations were measured without deviation at all blood sampling timepoints during the OPC-14597 IMD treatment period. | Posted | Mean | Standard Deviation | ng/mL | 672 hours postdose of the first, second, third, fourth, and fifth IMD injections |
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20 weeks of treatment period + posttreatment observation period (57 days after administration of the fifth IMD)
Only treatment-emergent adverse events (TEAEs) were assessed for this trial.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OPC-14597 IMD | Administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals | 0 | 17 | 2 | 17 | 15 | 17 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Schizophrenia | Psychiatric disorders | MedDRA Ver. 17.0 | Non-systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 17.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA Ver. 17.0 | Non-systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA Ver. 17.0 | Non-systematic Assessment |
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| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA Ver. 17.0 | Non-systematic Assessment |
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| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA Ver. 17.0 | Non-systematic Assessment |
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| Schizophrenia | Psychiatric disorders | MedDRA Ver. 17.0 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA Ver. 17.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Ver. 17.0 | Non-systematic Assessment |
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| Dyskinesia | Nervous system disorders | MedDRA Ver. 17.0 | Non-systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA Ver. 17.0 | Non-systematic Assessment |
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| Sinus bradycardia | Cardiac disorders | MedDRA Ver. 17.0 | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA Ver. 17.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Ver. 17.0 | Non-systematic Assessment |
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| Hepatic function abnormal | Hepatobiliary disorders | MedDRA Ver. 17.0 | Non-systematic Assessment |
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| Injection site pain | General disorders | MedDRA Ver. 17.0 | Non-systematic Assessment |
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| Injection site induration | Gastrointestinal disorders | MedDRA Ver. 17.0 | Non-systematic Assessment |
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| Injection site swelling | General disorders | MedDRA Ver. 17.0 | Non-systematic Assessment |
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| Injection site erythema | General disorders | MedDRA Ver. 17.0 | Non-systematic Assessment |
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| Injection site discomfort | General disorders | MedDRA Ver. 17.0 | Non-systematic Assessment |
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| Weight increased | Investigations | MedDRA Ver. 17.0 | Non-systematic Assessment |
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| Blood glucose increased | Investigations | MedDRA Ver. 17.0 | Non-systematic Assessment |
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| Blood insulin increased | Investigations | MedDRA Ver. 17.0 | Non-systematic Assessment |
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| Blood thyroid stimulating hormone increased | Investigations | MedDRA Ver. 17.0 | Non-systematic Assessment |
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| Glucose urine present | Investigations | MedDRA Ver. 17.0 | Non-systematic Assessment |
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| Glycosylated haemoglobin increased | Investigations | MedDRA Ver. 17.0 | Non-systematic Assessment |
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| Blood alkaline phosphatase increased | Investigations | MedDRA Ver. 17.0 | Non-systematic Assessment |
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| Thermal burn | Injury, poisoning and procedural complications | MedDRA Ver. 17.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Otsuka Pharmaceutical Co., LTD. | +81-3-6361-7366 | CL_OPCJ_RDA_Team@otsuka.jp |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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