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| ID | Type | Description | Link |
|---|---|---|---|
| JNS007ER-JPN-S32 | Other Identifier | Janssen Pharmaceutical K.K., Japan |
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The purpose of this study is to assess the safety of JNS007ER 3-12 mg once daily in patients with schizophrenia over a long term period.
This is a 48-week, multicenter, open-label (all people know the identity of the intervention), non-controlled, arbitrary-dose study. The patients included in this study are those who participated in the preceding double-blind (neither physician nor patient knows the treatment that the patient receives) comparative trial (study JNS007ER-JPN-S31) of JNS007ER and completed the study, or those who remained in the study up to the evaluation at 2 weeks and discontinued the study after that for insufficient treatment efficacy. The study will assess the safety of JNS007ER in the clinical recommended dose range in a long term treatment. The dosage will be started at 6 mg/day, and it can be increased or decreased 3 mg at a time depending on the patient's symptom within the range of 3 mg/day to 12 mg/day. For dose adjustments, the investigator will evaluate the psychiatric symptoms before defining the dose change.
Detailed Description: Extended description of the protocol, including more technical information (as compared to the Brief Summary) if desired. Do not include the entire protocol; do not duplicate information recorded in other data elements, such as eligibility criteria or outcome measures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paliperidone extended-release (JNS007ER) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paliperidone extended-release (JNS007ER) | Drug | Type= range, unit= mg, number= 3-12, form= tablet, route= oral use. JNS007ER within the range of 3, 6, 9 and 12 mg will be orally administered once daily for 48 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events | The incidence of adverse events was measured by the percentage of patients who presented one or more adverse events. | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) | PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill). | Baseline, Week 48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutical K.K., Japan Clinical Trial | Janssen Pharmaceutical K.K. | Study Director |
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This study comprises patients who have participated in previous study JNS007ER-JPN-S31 (NCT00396565) and new patients. New patients were classified as group NO/PAL. Patients entering from study JNS007ER-JPN-S31 were classified according to their origin groups: placebo group (PLA/PAL), paliperidone group (PAL/PAL), and olanzapine group (OLZ/PAL).
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| ID | Title | Description |
|---|---|---|
| FG000 | NO/PAL Group | NO/PAL: group consisting of new patients. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg. |
| FG001 | PLA/PAL Group | PLA/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the placebo group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg. |
| FG002 | PAL/PAL Group | PAL/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the paliperidone ER group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg. |
| FG003 | OLZ/PAL | OLZ/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the olanzapine group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | NO/PAL Group | NO/PAL: group consisting of new patients. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg. |
| BG001 | PLA/PAL Group |
| 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 Continuous | Mean |
| 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 | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) | PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill). | Intent-to-treat (ITT) population | Posted | Mean | Standard Deviation | scores on a scale | Baseline, Week 48 |
|
48 weeks
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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 | Entire Group | Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Schizophrenia | Psychiatric disorders | MedDRA/J（Ver.10.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood prolactin increased | Investigations | MedDRA/J（Ver.10.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Janssen Pharm KK Japan | 03-4411-5067 |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| Change From Baseline in Clinical Global Impression - Severity (CGI-S) | The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill patients". | Baseline, Week 48 |
| Lack of Efficacy |
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| Worsening of complications |
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| Lost to Follow-up |
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| Adverse Event |
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| Physician Decision |
|
PLA/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the placebo group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg. |
| BG002 | PAL/PAL Group | PAL/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the paliperidone ER group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg. |
| BG003 | OLZ/PAL | OLZ/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the olanzapine group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
PLA/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the placebo group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg. |
| OG002 | PAL/PAL Group | PAL/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the paliperidone ER group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg. |
| OG003 | OLZ/PAL | OLZ/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the olanzapine group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg. |
|
|
| Secondary | Change From Baseline in Clinical Global Impression - Severity (CGI-S) | The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill patients". | Intent-to-treat (ITT) population | Posted | Mean | Standard Deviation | scores on a scale | Baseline, Week 48 |
|
|
|
| Primary | Incidence of Adverse Events | The incidence of adverse events was measured by the percentage of patients who presented one or more adverse events. | Intent-to-treat (ITT) population | Posted | Number | percentage of patients | 48 weeks |
|
|
|
| 10 |
| 228 |
| 222 |
| 228 |
| Pneumonia | Infections and infestations | MedDRA/J（Ver.10.0) | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA/J（Ver.10.0) | Non-systematic Assessment |
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| Akathisia | Nervous system disorders | MedDRA/J（Ver.10.0) | Non-systematic Assessment |
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| Pulmonary aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA/J（Ver.10.0) | Non-systematic Assessment |
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| Multiple organ failure | General disorders | MedDRA/J（Ver.10.0) | Non-systematic Assessment |
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| ECG corrected QT interval prolonged | Cardiac disorders | MedDRA/J（Ver.10.0) | Non-systematic Assessment |
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| Overdose | General disorders | MedDRA/J（Ver.10.0) | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA/J（Ver.10.0) | Non-systematic Assessment |
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| Schizophrenia | Psychiatric disorders | MedDRA/J（Ver.10.0) | Non-systematic Assessment |
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| Weight increased | General disorders | MedDRA/J（Ver.10.0) | Non-systematic Assessment |
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| Extrapyramidal disorder | Nervous system disorders | MedDRA/J（Ver.10.0) | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA/J（Ver.10.0) | Non-systematic Assessment |
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| Blood triglycerides increased | Metabolism and nutrition disorders | MedDRA/J（Ver.10.0) | Non-systematic Assessment |
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| Blood creatine phosphokinase increased | Metabolism and nutrition disorders | MedDRA/J（Ver.10.0) | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA/J（Ver.10.0) | Non-systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA/J（Ver.10.0) | Non-systematic Assessment |
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| Dental caries | Gastrointestinal disorders | MedDRA/J（Ver.10.0) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA/J（Ver.10.0) | Non-systematic Assessment |
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| Fever | General disorders | MedDRA/J（Ver.10.0) | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA/J（Ver.10.0) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA/J（Ver.10.0) | Non-systematic Assessment |
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| Abnormal hepatic function | Hepatobiliary disorders | MedDRA/J（Ver.10.0) | Non-systematic Assessment |
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| Backache | Musculoskeletal and connective tissue disorders | MedDRA/J（Ver.10.0) | Non-systematic Assessment |
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| Blood cholesterol increased | Metabolism and nutrition disorders | MedDRA/J（Ver.10.0) | Non-systematic Assessment |
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| Abrasion | Skin and subcutaneous tissue disorders | MedDRA/J（Ver.10.0) | Non-systematic Assessment |
|
The disclosure restriction on PI is that the sponsor can review results communications prior to public release and can embargo communications regarding results for a period as the sponsor requires.