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| ID | Type | Description | Link |
|---|---|---|---|
| JNS007ER-JPN-S31 | Other Identifier | Janssen Pharmaceutical K.K., Japan |
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The purpose of this study is to evaluate the effectiveness and safety of Extended Release Osmotic Controlled-Release Oral Delivery System (OROS) Paliperidone compared to placebo in patients with Schizophrenia. Olanzapine will be used as a reference drug in the study.
This is a multicenter, double blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), randomized (patients are assigned different treatments based on chance), placebo- and active-controlled, parallel-group study. Patients will be randomized into 1 of 3 treatment groups to receive oral dosages of Extended Release (ER) Osmotic Controlled-Release Oral Delivery System (OROS) paliperidone 6 mg, olanzapine 10 mg, or placebo. They will receive two capsules of Paliperidone ER 3 mg, placebo or Olanzapine 5 mg once daily after breakfast for 6 weeks. The study will include a screening period, followed by double-blind treatment for 6 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ER OROS paliperidone | Experimental | Extended Release (ER) Osmotic Controlled-Release Oral Delivery System (OROS) paliperidone |
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| Placebo | Placebo Comparator |
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| Olanzapine | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ER OROS paliperidone | Drug | Type= exact number, unit= mg, number= 3, form= tablet, route= oral use. Two tablets once daily for 6 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Total 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 and 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score | The PANSS Positive Subscale assesses seven positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology). | Baseline and 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutical K.K. Clinical Trial | Janssen Pharmaceutical K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aizu-Wakamatsu | Japan | |||||
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| Label | URL |
|---|---|
| A Study to Evaluate Efficacy and Safety of ER OROS Paliperidone in Patients With Schizophrenia | View source |
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Informed Consent was obtained from 394 patients. The actual number of patients randomized in the study was 321. 2 subjects discontinued before treatment. 319 subjects were treated and analyzed for safety. 318 subjects were analyzed for baseline characteristics and efficacy.
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| ID | Title | Description |
|---|---|---|
| FG000 | Paliperidone Extended Release (ER) (JNS007ER) | Two paliperidone ER (JNS007ER) 3 mg tablets once daily for 6 weeks |
| FG001 | Placebo | Two placebo tablets once daily for 6 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Drug | Form= tablet, route= oral use. Two tablets once daily for 6 weeks. |
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| Olanzapine | Drug | Type= exact number, unit= mg, number= 2.5, form= tablet, route= oral use. Four tablets once daily for 6 weeks. |
|
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score | The PANSS Negative Subscale assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology). | Baseline and 6 weeks |
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score | The PANSS General Psychopathology Subscale Score assesses 16 general psychopathology symptoms. The symptoms are rated on a 7-point scale, with a range of 16 (absent) to 112 (extreme psychopathology). | Baseline and 6 weeks |
| Proportion of Responders (≥30% Decrease in Total Positive and Negative Syndrome Scale [PANSS]) | Responders are subjects with 30% or more reduction from baseline in total PANSS score. 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 and 6 weeks |
| Change From Baseline in Clinical Global Impression Scale (CGI-S) | The CGI-S rating scale is a 7-point global assessment with scores as follows: 1 - Not ill, 2 - Very Mild, 3 - Mild, 4 - Moderate, 5 - Marked, 6 - Severe, and 7 - Extremely Severe. | Baseline and 6 weeks |
| Fujioka |
| Japan |
| Fujisawa | Japan |
| Fukui | Japan |
| Hadano | Japan |
| Himeji | Japan |
| Hiratsuka | Japan |
| Hiroshima | Japan |
| Ibaraki | Japan |
| Ichikawa | Japan |
| Iida | Japan |
| Inazawa | Japan |
| Itoman | Japan |
| Kaizuka | Japan |
| Kanzaki | Japan |
| Kashihara | Japan |
| Kitakyushu | Japan |
| Kochi | Japan |
| Kōshi | Japan |
| Kumamoto | Japan |
| Kurayoshi | Japan |
| Matsudo | Japan |
| Matsusaka | Japan |
| Moriguchi | Japan |
| Morioka | Japan |
| Nagoya | Japan |
| Naha | Japan |
| Nakagami | Japan |
| Nankoku | Japan |
| Nishinomiya | Japan |
| Noda | Japan |
| Numazu | Japan |
| Ohta | Japan |
| Okinawa | Japan |
| Oyama | Japan |
| Ōita | Japan |
| Sakai | Japan |
| Sapporo | Japan |
| Takasaki | Japan |
| Takatsuki | Japan |
| Tanba | Japan |
| Tokyo | Japan |
| Tottori | Japan |
| Toyama | Japan |
| Toyoake | Japan |
| Toyonaka | Japan |
| Tōgane | Japan |
| Tsuyama | Japan |
| Ueda | Japan |
| Urasoe | Japan |
| Uruma | Japan |
| Yanagawa | Japan |
| Yao | Japan |
| Yokkaichi | Japan |
| Yokohama | Japan |
| Yokosuka | Japan |
| FG002 | Olanzapine | Four olanzapine 2.5 mg tablets once daily for 6 weeks |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Paliperidone Extended Release (ER) (JNS007ER) | Two paliperidone ER (JNS007ER) 3 mg tablets once daily for 6 weeks |
| BG001 | Placebo | Two placebo tablets once daily for 6 weeks |
| BG002 | Olanzapine | Four olanzapine 2.5 mg tablets once daily for 6 weeks |
| BG003 | Total | Total of all reporting groups |
| 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 | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Total Positive and Negative Syndrome Scale (PANSS) score | PANSS is a medical scale that assesses various symptoms of schizophrenia. Symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). Total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill). | Mean | Standard Deviation | scores on a scale |
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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 | Change From Baseline in the Total 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). | Full Analysis Set excludes subjects who didn't receive test drug or didn't have post-treatment efficacy data. The Olanzapine (OLZ) group was set as an active drug group to examine clinical position of paliperidone (PAL) ER, and the superiority or non-inferiority of PAL ER 6mg to OLZ 10mg wasn't verified. LOCF imputation method was applied. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and 6 weeks |
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| Secondary | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score | The PANSS Positive Subscale assesses seven positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology). | Full Analysis Set excludes subjects who didn't receive test drug or didn't have post-treatment efficacy data. The Olanzapine(OLZ) group was set as an active drug group to examine clinical position of paliperidone(PAL) ER, and the superiority or non-inferiority of PAL ER 6mg to OLZ 10mg wasn't verified. LOCF imputation method was applied. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and 6 weeks |
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| Secondary | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score | The PANSS Negative Subscale assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology). | Full Analysis Set excludes subjects who didn't receive test drug or didn't have post-treatment efficacy data. The Olanzapine(OLZ) group was set as an active drug group to examine clinical position of paliperidone(PAL) ER, and the superiority or non-inferiority of PAL ER 6mg to OLZ 10mg wasn't verified. LOCF imputation method was applied. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and 6 weeks |
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| Secondary | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score | The PANSS General Psychopathology Subscale Score assesses 16 general psychopathology symptoms. The symptoms are rated on a 7-point scale, with a range of 16 (absent) to 112 (extreme psychopathology). | Full Analysis Set excludes subjects who didn't receive test drug or didn't have post-treatment efficacy data. The Olanzapine(OLZ) group was set as an active drug group to examine clinical position of paliperidone(PAL) ER, and the superiority or non-inferiority of PAL ER 6mg to OLZ 10mg wasn't verified. LOCF imputation method was applied. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and 6 weeks |
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| Secondary | Proportion of Responders (≥30% Decrease in Total Positive and Negative Syndrome Scale [PANSS]) | Responders are subjects with 30% or more reduction from baseline in total PANSS score. 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). | Full Analysis Set excludes subjects who didn't receive test drug or didn't have post-treatment efficacy data. The Olanzapine(OLZ) group was set as an active drug group to examine clinical position of paliperidone(PAL) ER, and the superiority or non-inferiority of PAL ER 6mg to OLZ 10mg wasn't verified. LOCF imputation method was applied. | Posted | Number | Percentage of participants | Baseline and 6 weeks |
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| Secondary | Change From Baseline in Clinical Global Impression Scale (CGI-S) | The CGI-S rating scale is a 7-point global assessment with scores as follows: 1 - Not ill, 2 - Very Mild, 3 - Mild, 4 - Moderate, 5 - Marked, 6 - Severe, and 7 - Extremely Severe. | Full Analysis Set excludes subjects who didn't receive test drug or didn't have post-treatment efficacy data. The Olanzapine(OLZ) group was set as an active drug group to examine clinical position of paliperidone(PAL) ER, and the superiority or non-inferiority of PAL ER 6mg to OLZ 10mg wasn't verified. LOCF imputation method was applied. | Posted | Mean | Standard Error | scores on a scale | Baseline and 6 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 | Paliperidone Extended Release (ER) (JNS007ER) | Two paliperidone ER (JNS007ER) 3 mg tablets once daily for 6 weeks | 4 | 134 | 109 | 134 | ||
| EG001 | Placebo | Two placebo tablets once daily for 6 weeks | 1 | 138 | 110 | 138 | ||
| EG002 | Olanzapine | Four olanzapine 2.5 mg tablets once daily for 6 weeks | 2 | 47 | 40 | 47 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| schizophrenia | Psychiatric disorders | MedDRA/J v10.0 | Systematic Assessment |
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| pneumonia | Infections and infestations | MedDRA/J v10.0 | Systematic Assessment |
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| mood altered | Psychiatric disorders | MedDRA/J v10.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| schizophrenia | Psychiatric disorders | MedDRA/J v10.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA/J v10.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA/J v10.0 | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA/J v10.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA/J v10.0 | Systematic Assessment |
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| Weight increased | Investigations | MedDRA/J v10.0 | Systematic Assessment |
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| Blood triglycerides increased | Investigations | MedDRA/J v10.0 | Systematic Assessment |
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| Extrapyramidal disorder | Nervous system disorders | MedDRA/J v10.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA/J v10.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA/J v10.0 | Systematic Assessment |
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| Basophil count increased | Investigations | MedDRA/J v10.0 | Systematic Assessment |
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| Hepatic function abnormal | Hepatobiliary disorders | MedDRA/J v10.0 | Systematic Assessment |
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| Thirst | General disorders | MedDRA/J v10.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA/J v10.0 | Systematic Assessment |
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| White blood cell count increased | Investigations | MedDRA/J v10.0 | Systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA/J v10.0 | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA/J v10.0 | Systematic Assessment |
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Without prior notification to the sponsor, the PI cannnot dislose trial results and related documents of trials to a third party.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical R&D Dept. 3 | Janssen Pharmaceutical K.K. | 81-3-4411-5652 | 10118 |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077152 | Olanzapine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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