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| ID | Type | Description | Link |
|---|---|---|---|
| PALM-JPN-2 | Other Identifier | Janssen Pharmaceutical K.K., Japan |
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The purpose of this study is to assess the pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) and safety of paliperidone palmitate in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).
This is a multicenter (when more than one hospital or medical school team work on a medical research study), open-label (all people know the identity of the intervention), randomized (the study drug is assigned by chance), parallel-group (Each group of participants will be treated at the same time), comparison study to assess the pharmacokinetics and safety of paliperidone palmitate (study medication) in participants with schizophrenia. The study comprises a 64-day Treatment period and a 155-day Follow-up period. The participants will be randomly assigned to one of the four study groups. The study medication will be administered on Days 1, 8, 36 and 64. Pharmacokinetics of the study medication will be assessed as primary outcome. Participants' safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paliperidone palmitate 50 mg | Experimental | Paliperidone palmitate 50 milligram (mg) intramuscular (into the muscle) injection on Days 1, 8, 36 and 64. |
|
| Paliperidone palmitate 100 mg | Experimental | Paliperidone palmitate 100 mg intramuscular injection on Days 1, 8, 36 and 64. |
|
| Paliperidone palmitate 150 mg | Experimental | Paliperidone palmitate 150 mg intramuscular injection on Days 1, 8, 36 and 64. |
|
| Paliperidone palmitate 150/ 50 mg | Experimental | Paliperidone palmitate 150 mg intramuscular injection on Day 1 and paliperidone palmitate 50 mg intramuscular injection on Days 8, 36 and 64. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paliperidone palmitate | Drug | Paliperidone palmitate aqueous suspension for injection 0.5, 1.0, 1.5 milliliter equivalent to 50, 100, 150 mg paliperidone respectively as intramuscular injection on Days 1, 8, 36 and 64. |
| Measure | Description | Time Frame |
|---|---|---|
| Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 8 | The pre-dose plasma concentration (Cpredose) at Day 8 is defined as the plasma concentration obtained before a dose is given on Day 8. The mean Cpredose at Day 8 was measured in nanogram per milliliter (ng/ml). | Day 8 |
| Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 36 | The Cpredose at Day 36 is defined as the plasma concentration obtained before a dose is given on Day 36. The mean Cpredose at Day 36 was measured in ng/ml. | Day 36 |
| Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 64 | The Cpredose at Day 64 is defined as the plasma paliperidone concentration obtained before a dose is given on Day 64. The mean Cpredose at Day 64 was measured in ng/ml. | Day 64 |
| Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 92 | The Cpredose at Day 92 is defined as the plasma paliperidone concentration obtained after the treatment interval of the study drug (that is 4 weeks) passed after the final dose (Day 92). The mean Cpredose at Day 92 was measured in ng/ml. | Day 92 |
| Maximum Observed Plasma Concentration (Cmax) of Paliperidone | The Cmax is defined as maximum observed analyte concentration. | Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of Paliperidone | The Tmax is defined as actual sampling time to reach maximum observed analyte concentration. |
| Measure | Description | Time Frame |
|---|---|---|
| Positive and Negative Syndrome Scale (PANSS) Total Score | The 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, Day 8, 22, 50, 78 and 92 |
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Inclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutical K.K., Japan Clinical Trial | Janssen Pharmaceutical K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ichikawa | Japan |
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| ID | Title | Description |
|---|---|---|
| FG000 | Paliperidone Palmitate 50 mg | Paliperidone palmitate (JNS010) 50 milligram (mg) intramuscular (into the muscle) injection administered on Days 1, 8, 36 and 64. |
| FG001 | Paliperidone Palmitate 100 mg | Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64. |
| FG002 | Paliperidone Palmitate 150 mg | Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64. |
| FG003 | Paliperidone Palmitate 150/ 50 mg | Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Paliperidone Palmitate 50 mg | Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64. |
| BG001 | Paliperidone Palmitate 100 mg | Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64. |
| 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 | Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 8 | The pre-dose plasma concentration (Cpredose) at Day 8 is defined as the plasma concentration obtained before a dose is given on Day 8. The mean Cpredose at Day 8 was measured in nanogram per milliliter (ng/ml). | Pharmacokinetic analysis set included all participants who received the study treatment and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure. | Posted | Mean | Standard Deviation | ng/ml | Day 8 |
|
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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 Palmitate 50 mg | Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psychiatric symptom | Psychiatric disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Janssen Pharm KK Japan | 81-3-4411 | 5509 |
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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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|
| Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal |
| Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) | The AUCtau is a measure of the plasma paliperidone concentration from time zero to end of dosing interval. It is used to characterize drug absorption. | Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal |
| Plasma Paliperidone Concentration at Steady State (Css av) | The Css av is defined as value of average analyte concentration at steady-state (after 4 Intramuscular Injections of Paliperidone Palmitate). | Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal |
| Paliperidone Plasma Decay Half-Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal |
| Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 8 | The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 [none, normal]; 1 [Very Mild]; 2 [Mild]; 3 [Moderate]; 4 [severe]). | Day 8 |
| Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 22 | The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 [none, normal]; 1 [Very Mild]; 2 [Mild]; 3 [Moderate]; 4 [severe]). | Day 22 |
| Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 50 | The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 [none, normal]; 1 [Very Mild]; 2 [Mild]; 3 [Moderate]; 4 [severe]). | Day 50 |
| Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 78 | The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 [none, normal]; 1 [Very Mild]; 2 [Mild]; 3 [Moderate]; 4 [severe]). | Day 78 |
| Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 92 | The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 [none, normal]; 1 [Very Mild]; 2 [Mild]; 3 [Moderate]; 4 [severe]). | Day 92 |
| Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 120 | The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 [none, normal]; 1 [Very Mild]; 2 [Mild]; 3 [Moderate]; 4 [severe]). | Day 120 |
| Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 162 | The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 [none, normal]; 1 [Very Mild]; 2 [Mild]; 3 [Moderate]; 4 [severe]). | Day 162 |
| Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 218 | The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 [none, normal]; 1 [Very Mild]; 2 [Mild]; 3 [Moderate]; 4 [severe]). | Day 218 |
| Number of Participants With Clinical Global Impression Severity (CGI-S) Score | The CGI-S rating scale is a 7 point (1-absent, 2-minimal, 3-mild, 4-moderate, 5-moderate severe, 6-severe, 7-extreme) global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. 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 participants". Higher scores indicate worsening. | Baseline, Day 8, 22, 50, 78 and 92 |
| Adverse Event |
|
| BG002 | Paliperidone Palmitate 150 mg | Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64. |
| BG003 | Paliperidone Palmitate 150/ 50 mg | Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64. |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Number of Participants with Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score | Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS) is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 [none, normal]; 1 [Very Mild]; 2 [Mild]; 3 [Moderate]; 4 [severe]). | Number | Participant |
|
Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64. |
| OG002 | Paliperidone Palmitate 150 mg | Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64. |
| OG003 | Paliperidone Palmitate 150/ 50 mg | Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64. |
|
|
| Primary | Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 36 | The Cpredose at Day 36 is defined as the plasma concentration obtained before a dose is given on Day 36. The mean Cpredose at Day 36 was measured in ng/ml. | Pharmacokinetic analysis set included all participants who received the study treatment and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure. | Posted | Mean | Standard Deviation | ng/ml | Day 36 |
|
|
|
| Primary | Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 64 | The Cpredose at Day 64 is defined as the plasma paliperidone concentration obtained before a dose is given on Day 64. The mean Cpredose at Day 64 was measured in ng/ml. | Pharmacokinetic analysis set included all participants who received the study treatment and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure. | Posted | Mean | Standard Deviation | ng/ml | Day 64 |
|
|
|
| Primary | Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 92 | The Cpredose at Day 92 is defined as the plasma paliperidone concentration obtained after the treatment interval of the study drug (that is 4 weeks) passed after the final dose (Day 92). The mean Cpredose at Day 92 was measured in ng/ml. | Pharmacokinetic analysis set included all participants who received the study treatment and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure. | Posted | Mean | Standard Deviation | ng/ml | Day 92 |
|
|
|
| Primary | Maximum Observed Plasma Concentration (Cmax) of Paliperidone | The Cmax is defined as maximum observed analyte concentration. | Pharmacokinetic analysis set included all participants who received the study medication and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure. | Posted | Mean | Standard Deviation | ng/ml | Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal |
|
|
|
| Primary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Paliperidone | The Tmax is defined as actual sampling time to reach maximum observed analyte concentration. | Pharmacokinetic analysis set included all participants who received the study medication and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure. | Posted | Median | Full Range | Days | Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal |
|
|
|
| Primary | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) | The AUCtau is a measure of the plasma paliperidone concentration from time zero to end of dosing interval. It is used to characterize drug absorption. | Pharmacokinetic analysis set included all participants who received the study medication and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure. | Posted | Mean | Standard Deviation | nanogram*hour per milliliter | Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal |
|
|
|
| Primary | Plasma Paliperidone Concentration at Steady State (Css av) | The Css av is defined as value of average analyte concentration at steady-state (after 4 Intramuscular Injections of Paliperidone Palmitate). | Pharmacokinetic analysis set included all participants who received the study medication and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure. | Posted | Mean | Standard Deviation | ng/ml | Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal |
|
|
|
| Primary | Paliperidone Plasma Decay Half-Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | Pharmacokinetic analysis set included all participants who received the study medication and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure. | Posted | Mean | Standard Deviation | Days | Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal |
|
|
|
| Primary | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 8 | The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 [none, normal]; 1 [Very Mild]; 2 [Mild]; 3 [Moderate]; 4 [severe]). | Safety analysis set included all participants who were enrolled in the study and received the study medication at least once. | Posted | Number | Participants | Day 8 |
|
|
|
| Primary | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 22 | The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 [none, normal]; 1 [Very Mild]; 2 [Mild]; 3 [Moderate]; 4 [severe]). | Safety analysis set included all participants who were enrolled in the study and received the study medication at least once. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure. | Posted | Number | Participants | Day 22 |
|
|
|
| Primary | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 50 | The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 [none, normal]; 1 [Very Mild]; 2 [Mild]; 3 [Moderate]; 4 [severe]). | Safety analysis set included all participants who were enrolled in the study and received the study medication at least once. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure. | Posted | Number | Participants | Day 50 |
|
|
|
| Primary | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 78 | The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 [none, normal]; 1 [Very Mild]; 2 [Mild]; 3 [Moderate]; 4 [severe]). | Safety analysis set included all participants who were enrolled in the study and received the study medication at least once. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure. | Posted | Number | Participants | Day 78 |
|
|
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| Primary | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 92 | The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 [none, normal]; 1 [Very Mild]; 2 [Mild]; 3 [Moderate]; 4 [severe]). | Safety analysis set included all participants who were enrolled in the study and received the study medication at least once. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure. | Posted | Number | Participants | Day 92 |
|
|
|
| Primary | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 120 | The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 [none, normal]; 1 [Very Mild]; 2 [Mild]; 3 [Moderate]; 4 [severe]). | Safety analysis set included all participants who were enrolled in the study and received the study medication at least once. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure. | Posted | Number | Participants | Day 120 |
|
|
|
| Primary | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 162 | The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 [none, normal]; 1 [Very Mild]; 2 [Mild]; 3 [Moderate]; 4 [severe]). | Safety analysis set included all participants who were enrolled in the study and received the study medication at least once. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure. | Posted | Number | Participants | Day 162 |
|
|
|
| Primary | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 218 | The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 [none, normal]; 1 [Very Mild]; 2 [Mild]; 3 [Moderate]; 4 [severe]). | Safety analysis set included all participants who were enrolled in the study and received the study medication at least once. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure. | Posted | Number | Participants | Day 218 |
|
|
|
| Secondary | Positive and Negative Syndrome Scale (PANSS) Total Score | The 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). | Per protocol set (PPS) included all participants who were enrolled in the study, received study medication at least once and had at least one efficacy evaluation. Last observation carried forward (LOCF) imputation method was used. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Day 8, 22, 50, 78 and 92 |
|
|
|
| Secondary | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | The CGI-S rating scale is a 7 point (1-absent, 2-minimal, 3-mild, 4-moderate, 5-moderate severe, 6-severe, 7-extreme) global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. 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 participants". Higher scores indicate worsening. | The PPS included all participants who were enrolled in the study, received study medication at least once and had at least one efficacy evaluation. LOCF imputation method was used. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group. | Posted | Number | Participants | Baseline, Day 8, 22, 50, 78 and 92 |
|
|
|
| 1 |
| 14 |
| 14 |
| 14 |
| EG001 | Paliperidone Palmitate 100 mg | Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64. | 0 | 14 | 14 | 14 |
| EG002 | Paliperidone Palmitate 150 mg | Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64. | 2 | 14 | 14 | 14 |
| EG003 | Paliperidone Palmitate 150/ 50 mg | Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64. | 3 | 14 | 14 | 14 |
| Schizophrenia | Psychiatric disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Grand mal convulsion | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Neuroleptic malignant syndrome | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Hypothermia | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Otitis externa | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Purulence | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Hyperphagia | Metabolism and nutrition disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Psychiatric symptom | Psychiatric disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Hypochondriasis | Psychiatric disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Abulia | Psychiatric disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Delusion | Psychiatric disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Hallucination, auditory | Psychiatric disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Middle insomnia | Psychiatric disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Akathisia | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Dyskinesia | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Dystonia | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Delayed sleep phase | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Hypersomnia | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Sedation | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Stupor | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Restless legs syndrome | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Asthenopia | Eye disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Blepharitis | Eye disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Supraventricular extrasystoles | Cardiac disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Ventricular extrasystoles | Cardiac disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Stomach discomfort | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Periodontitis | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Gastrointestinal motility disorder | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Post-tussive vomiting | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Heat rash | Skin and subcutaneous tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Injection site pain | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Injection site induration | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Thirst | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Injection site bruising | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Irritability | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Mass | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Blood prolactin increased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Weight increased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Blood prolactin decreased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Protein urine present | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Blood albumin decreased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Blood chloride decreased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Blood sodium decreased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Blood triglycerides decreased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Electrocardiogram ST segment depression | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Blood urine present | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Low density lipoprotein increased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Protein total decreased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Urine ketone body present | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Device breakage | Injury, poisoning and procedural complications | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Epicondylitis | Injury, poisoning and procedural complications | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Joint sprain | Injury, poisoning and procedural complications | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Muscle injury | Injury, poisoning and procedural complications | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA Version 11.0 | Non-systematic Assessment |
|
Not provided
Not provided
| D011743 |
| Pyrimidines |
| Very mild |
|
| Mild |
|
| Very mild |
|
| Mild |
|
| Very mild |
|
| Mild |
|
| Very mild |
|
| Mild |
|
| Very mild |
|
| Mild |
|
| Very mild |
|
| Mild |
|
| Very mild |
|
| Mild |
|
| Very mild |
|
| Mild |
|
| Day 8 (n = 14, 14, 13, 14) |
|
| Day 22 (n = 14, 14, 14, 14) |
|
| Day 50 (n = 14, 14, 14, 14) |
|
| Day 78 (n = 14, 14, 14, 14) |
|
| Day 92 (n = 14, 14, 14, 14) |
|
| Baseline, Mild (n=14,14,14,14) |
|
| Baseline, Moderate (n=14,14,14,14) |
|
| Baseline, Moderate severe (n=14,14,14,14) |
|
| Day 8, Minimal (n=14,14,13,14) |
|
| Day 8, Mild (n=14,14,13,14) |
|
| Day 8, Moderate (n=14,14,13,14) |
|
| Day 8, Moderate severe (n=14,14,13,14) |
|
| Day 22, Minimal (n=14,14,14,14) |
|
| Day 22, Mild (n=14,14,14,14) |
|
| Day 22, Moderate (n=14,14,14,14) |
|
| Day 22, Moderate severe (n=14,14,14,14) |
|
| Day 50, Minimal (n=14,14,14,14) |
|
| Day 50, Mild (n=14,14,14,14) |
|
| Day 50, Moderate (n=14,14,14,14) |
|
| Day 50, Moderate severe (n=14,14,14,14) |
|
| Day 78, Minimal (n=14,14,14,14) |
|
| Day 78, Mild (n=14,14,14,14) |
|
| Day 78, Moderate (n=14,14,14,14) |
|
| Day 78, Moderate severe (n=14,14,14,14) |
|
| Day 92, Minimal (n=14,14,14,14) |
|
| Day 92, Mild(n=14,14,14,14) |
|
| Day 92, Moderate (n=14,14,14,14) |
|
| Day 92, Moderate severe (n=14,14,14,14) |
|