A Pharmacokinetic and Safety Study of Paliperidone Palmitate (JNS010) in Participants With Schizophrenia
Information source: Janssen Pharmaceutical K.K.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: Paliperidone palmitate (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Janssen Pharmaceutical K.K. Official(s) and/or principal investigator(s): Janssen Pharmaceutical K.K., Japan Clinical Trial, Study Director, Affiliation: Janssen Pharmaceutical K.K.
Summary
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).
Clinical Details
Official title: A Repeated Dose Study of JNS010 (Paliperidone Palmitate) in Patients With Schizophrenia
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 8Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 36 Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 64 Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 92 Maximum Observed Plasma Concentration (Cmax) of Paliperidone Time to Reach Maximum Observed Plasma Concentration (Tmax) of Paliperidone Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) Plasma Paliperidone Concentration at Steady State (Css av) Paliperidone Plasma Decay Half-Life (t1/2) Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 8 Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 22 Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 50 Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 78 Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 92 Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 120 Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 162 Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 218
Secondary outcome: Positive and Negative Syndrome Scale (PANSS) Total ScoreNumber of Participants With Clinical Global Impression Severity (CGI-S) Score
Detailed description:
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.
Eligibility
Minimum age: 20 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria
- Participants who have been diagnosed with schizophrenia in accordance with the
diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders 4th
edition (DSM-IV)
- Participants may be inpatients or outpatients
- Participants who have been taking an oral antipsychotic medication for at least 28
days before the date of informed consent
- Participants with a Positive and Negative Syndrome Scale (PANSS) score of less than
or equal to 4 (moderate) at screening
- Participants who have taken risperidone by the start of investigational treatment and
the record can be confirmed Exclusion Criteria
- Participants who have been diagnosed with a mental disease other than schizophrenia
in accordance with the diagnostic criteria of Diagnostic and Statistical Manual of
Mental Disorders 4th edition (DSM-IV)
- Participants who have been diagnosed with substance-related disorders (except
nicotine and caffeine dependence)
- Participants with complicated parkinson's disease (a progressive disorder of the
central nervous system, seen usually in older persons, in which there is muscle
weakness, trembling and sweating)
- Participants with a complication of or with a history of convulsive disease such as
epilepsy (seizure disorder)
- Participants with a complication of or with a history of cerebro-vascular accident
(stroke), neuroleptic malignant syndrome (high fever, rigid muscles, shaking,
confusion, sweating more than usual, increased heart rate or blood pressure, or
muscle pain or weakness) or physical exhaustion associated with the state of
dehydration (lose of water and minerals in the body) or malnutrition
Locations and Contacts
Ichikawa, Japan
Additional Information
Starting date: January 2007
Last updated: May 28, 2013
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