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| ID | Type | Description | Link |
|---|---|---|---|
| R076477SCH3033 | Other Identifier | Janssen Pharmaceutica | |
| PAL-PHL-MA3 | Other Identifier | Janssen Pharmaceutica |
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The purpose of this study is to explore the tolerability, safety and efficacy of flexibly dosed paliperidone extended release (ER) among patients with schizophrenia.
This is a single arm (the same intervention is given to all patients), multicenter study that aimed to explore the tolerability, safety and efficacy of flexibly dosed paliperidone extended release (ER) among Filipino patients with schizophrenia who have not taken any antipsychotics in the past, and among newly diagnosed schizophrenia patients who have not taken any antipsychotics for at least one month prior to screening. Antipsychotics are drugs that are helpful in the treatment of psychosis and have a capacity to ameliorate thought disorders. Flexible dosing allows the investigators to adjust the dosage of each patient based on the individual needs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paliperidone ER | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paliperidone ER | Drug | Type= range, unit= mg/day, number= 3 to 12, form= tablet, route= oral use. Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day. |
| Measure | Description | Time Frame |
|---|---|---|
| The Proportion of Patients Improving 20% in Total Positive and Negative Syndrome Scale (PANSS) at Endpoint (Day 90) | The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening. | Baseline, Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Positive and Negative Syndrome Scale (PANSS) Scores at Baseline | The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutica Clinical Trial | Janssen Pharmaceutica | Study Director |
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There were 188 patients enrolled in the study which were included in the safety analysis set. The main analysis set included only 176 subjects due to 12 protocol violations. Of these 176 patients, only 73 were included in the per-protocol analysis set. For the Clinical Global Impression-Severity scores, data was collected for only 60 patients.
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| ID | Title | Description |
|---|---|---|
| FG000 | Paliperidone Extended-release (ER) | Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Paliperidone Extended-release (ER) | Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Proportion of Patients Improving 20% in Total Positive and Negative Syndrome Scale (PANSS) at Endpoint (Day 90) | The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening. | Per Protocol (PP) population | Posted | Number | percentage of patients | Baseline, Day 90 |
|
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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) | Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Schizophrenia paranoid type | Psychiatric disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Insomnia | Psychiatric disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Affairs Director, CNS, Asia Pacific | Janssen China | 8610 5821 8766 |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000068882 | Paliperidone Palmitate |
| ID | Term |
|---|---|
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Baseline |
| Positive and Negative Syndrome Scale (PANSS) Scores at Day 90 | The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening. | Day 90 |
| Clinical Global Impression-Severity (CGIS) Scores at Baseline | 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. The rating varies from "Normal (not at all ill)" to "Extreme (among the most extremely ill patients)". | Baseline |
| Clinical Global Impression-Severity (CGIS) Scores at Day 90 | 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. The rating varies from "Normal (not at all ill)" to "Extreme (among the most extremely ill patients)". | Day 90 |
| Personal and Social Performance (PSP) Scores at Baseline | This PSP assesses the degree of a patient's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (i, absent to vi, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Patients with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; =< 30, functioning so poorly as to require intensive supervision. | Baseline |
| Personal and Social Performance (PSP) Scores at Day 90 | This PSP assesses the degree of a patient's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (i, absent to vi, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Patients with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; =< 30, functioning so poorly as to require intensive supervision. | Day 90 |
| Patient Satisfaction With Paliperidone Treatment | Patients will be interviewed to assess their satisfaction with the current treatment on a 5-point scale (very good, good, reasonable, moderate or poor). | 90 days |
| Quality of Sleep at Baseline | The quality of sleep is measured by a self-administered scale in which patients indicate how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well). | Baseline |
| Quality of Sleep at Day 90 | The quality of sleep is measured by a self-administered scale in which patients indicate how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well). | Day 90 |
| Daytime Drowsiness at Baseline | The daytime drowsiness is measured by a self-administered scale in which patients indicate how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time). | Baseline |
| Daytime Drowsiness at Day 90 | The daytime drowsiness is measured by a self-administered scale in which patients indicate how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time). | Day 90 |
| Lack of Efficacy |
|
| Adverse Event |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Positive and Negative Syndrome Scale (PANSS) Scores at Baseline | The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening. | Per Protocol (PP) population | Posted | Mean | Standard Deviation | scores on a scale | Baseline |
|
|
|
| Secondary | Positive and Negative Syndrome Scale (PANSS) Scores at Day 90 | The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening. | Per Protocol (PP) population | Posted | Mean | Standard Deviation | scores on a scale | Day 90 |
|
|
|
| Secondary | Clinical Global Impression-Severity (CGIS) Scores at Baseline | 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. The rating varies from "Normal (not at all ill)" to "Extreme (among the most extremely ill patients)". | Per Protocol (PP) population; participants for whom CGIS data was collected. | Posted | Number | participants | Baseline |
|
|
|
| Secondary | Clinical Global Impression-Severity (CGIS) Scores at Day 90 | 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. The rating varies from "Normal (not at all ill)" to "Extreme (among the most extremely ill patients)". | Per Protocol (PP) population | Posted | Number | participants | Day 90 |
|
|
|
| Secondary | Personal and Social Performance (PSP) Scores at Baseline | This PSP assesses the degree of a patient's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (i, absent to vi, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Patients with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; =< 30, functioning so poorly as to require intensive supervision. | Per Protocol (PP) population | Posted | Mean | Standard Deviation | scores on a scale | Baseline |
|
|
|
| Secondary | Personal and Social Performance (PSP) Scores at Day 90 | This PSP assesses the degree of a patient's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (i, absent to vi, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Patients with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; =< 30, functioning so poorly as to require intensive supervision. | Per Protocol (PP) population | Posted | Mean | Standard Deviation | scores on a scale | Day 90 |
|
|
|
| Secondary | Patient Satisfaction With Paliperidone Treatment | Patients will be interviewed to assess their satisfaction with the current treatment on a 5-point scale (very good, good, reasonable, moderate or poor). | Per Protocol (PP) population | Posted | Number | participants | 90 days |
|
|
|
| Secondary | Quality of Sleep at Baseline | The quality of sleep is measured by a self-administered scale in which patients indicate how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well). | Per Protocol (PP) population | Posted | Mean | Standard Deviation | scores on a scale | Baseline |
|
|
|
| Secondary | Quality of Sleep at Day 90 | The quality of sleep is measured by a self-administered scale in which patients indicate how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well). | Per Protocol (PP) population | Posted | Mean | Standard Deviation | scores on a scale | Day 90 |
|
|
|
| Secondary | Daytime Drowsiness at Baseline | The daytime drowsiness is measured by a self-administered scale in which patients indicate how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time). | Per Protocol (PP) population | Posted | Mean | Standard Deviation | scores on a scale | Baseline |
|
|
|
| Secondary | Daytime Drowsiness at Day 90 | The daytime drowsiness is measured by a self-administered scale in which patients indicate how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time). | Per Protocol (PP) population | Posted | Mean | Standard Deviation | scores on a scale | Day 90 |
|
|
|
| 4 |
| 188 |
| 43 |
| 188 |
| Arrhythmia | Cardiac disorders |
|
| Ventricular Extrasystoles | Cardiac disorders |
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| Akathisia | Nervous system disorders |
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| Schizophrenia | Psychiatric disorders |
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| Anemia | Metabolism and nutrition disorders |
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| Hypertension | Vascular disorders |
|
| Pyrexia | General disorders |
|
| Extra-Pyramidal Symptoms | Nervous system disorders |
|
| Akathisia | Nervous system disorders |
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| Acute psychotic symptoms | Psychiatric disorders |
|
| Poor appetite | Metabolism and nutrition disorders |
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| Disturbed behavior | Psychiatric disorders |
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| Sialorrhea | Gastrointestinal disorders |
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| Cough | Respiratory, thoracic and mediastinal disorders |
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| Otitis media | Infections and infestations |
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| Restlessness | Nervous system disorders |
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| Breast pain | General disorders |
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| Urinary Tract Infection | Infections and infestations |
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| Verbal assault | Social circumstances |
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| Fungal infection | Infections and infestations |
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| Upper Respiratory Tract Infection | Infections and infestations |
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| Dizziness/Vertigo | Nervous system disorders |
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| Headache | Nervous system disorders |
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| Pruritus | Skin and subcutaneous tissue disorders |
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| Constipation | Gastrointestinal disorders |
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| Colds/nasal congestion | Respiratory, thoracic and mediastinal disorders |
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| Tremors | Nervous system disorders |
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| Dystonia | Nervous system disorders |
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| Skin allergy | Skin and subcutaneous tissue disorders |
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| Upward gazing | Eye disorders |
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| Orthostatic hypotension | Vascular disorders |
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| Back pain | Musculoskeletal and connective tissue disorders |
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| Acute Gastroenteritis | Gastrointestinal disorders |
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| Swelling of arm | General disorders |
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| Sore throat | General disorders |
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| Eczematous lesion | Skin and subcutaneous tissue disorders |
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| External Hemorrhoid | Vascular disorders |
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| Pharyngitis | Infections and infestations |
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| Diabetes | Metabolism and nutrition disorders |
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| Sprain | Musculoskeletal and connective tissue disorders |
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| Scabies | Infections and infestations |
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| Manic-like behavior | Psychiatric disorders |
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| Delusions | Psychiatric disorders |
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| Hypokalemia | Metabolism and nutrition disorders |
|
| Renal Insufficiency | Renal and urinary disorders |
|
| Pulmonary Tuberculosis | Infections and infestations |
|
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| D011743 |
| Pyrimidines |
| Title | Measurements |
|---|
|
| Moderate |
|
| Marked |
|
| Severe |
|
| Extreme |
|
| Title | Measurements |
|---|
|
| Moderate |
|
| Marked |
|
| Severe |
|
| Extreme |
|
| Title |
|---|
| Measurements |
|---|
|
| Poor |
|
| Very poor |
|