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A Long-Term Study of JNS007ER in Patients With Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Paliperidone extended-release (JNS007ER)
Sponsored by
Janssen Pharmaceutical K.K.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, JNS007ER, Paliperidone extended-release

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients diagnosed with schizophrenia
  • Patients who have given their own consent in writing to participate in the study
  • Patients untreated with antipsychotics within 28 days before the screening test
  • Patients who have completed Study JNS007ER-JPN-S31, or those who continued the study at least up to the evaluation at 2 weeks and subsequently discontinued the study due to insufficient efficacy
  • Patients participating in Study JNS007ER-JPN-S31 and whose ratio of treatment to the evaluation at 2 weeks is ≥75%

Exclusion Criteria:

  • Patients diagnosed with a mental disease other than schizophrenia
  • A total PANSS score > 120 at baseline
  • Substance-related disorders
  • Parkinson's disease complications
  • Current or a past history of convulsive disease such as epilepsy
  • Current or a past history of cerebrovascular accident
  • Diabetes mellitus
  • Significant hepatic or renal impairment
  • Significant cardiovascular disorders
  • Abnormal results of hematological examination, blood chemistry test and urinalysis at screening
  • Pregnant women, breast-feeding mothers, and patients who wish pregnancy during the study period or those whose pregnancy test at screening was positive
  • Contraindications to risperidone products
  • Patients who discontinued Study JNS007ER-JPN-S31 due to an adverse event not related to the underlying disease
  • Patients judged inadequate by the investigator to participate in the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Paliperidone extended-release (JNS007ER)

    Arm Description

    Outcomes

    Primary Outcome Measures

    Incidence of Adverse Events
    The incidence of adverse events was measured by the percentage of patients who presented one or more adverse events.

    Secondary Outcome Measures

    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).
    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".

    Full Information

    First Posted
    March 22, 2012
    Last Updated
    September 14, 2012
    Sponsor
    Janssen Pharmaceutical K.K.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01561898
    Brief Title
    A Long-Term Study of JNS007ER in Patients With Schizophrenia
    Official Title
    A Long-Term Study of JNS007ER in Patients With Schizophrenia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2006 (undefined)
    Primary Completion Date
    October 2008 (Actual)
    Study Completion Date
    October 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Janssen Pharmaceutical K.K.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Schizophrenia
    Keywords
    Schizophrenia, JNS007ER, Paliperidone extended-release

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    228 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Paliperidone extended-release (JNS007ER)
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Paliperidone extended-release (JNS007ER)
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Incidence of Adverse Events
    Description
    The incidence of adverse events was measured by the percentage of patients who presented one or more adverse events.
    Time Frame
    48 weeks
    Secondary Outcome Measure Information:
    Title
    Change From Baseline in Positive and Negative Syndrome Scale (PANSS)
    Description
    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).
    Time Frame
    Baseline, Week 48
    Title
    Change From Baseline in Clinical Global Impression - Severity (CGI-S)
    Description
    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".
    Time Frame
    Baseline, Week 48

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients diagnosed with schizophrenia Patients who have given their own consent in writing to participate in the study Patients untreated with antipsychotics within 28 days before the screening test Patients who have completed Study JNS007ER-JPN-S31, or those who continued the study at least up to the evaluation at 2 weeks and subsequently discontinued the study due to insufficient efficacy Patients participating in Study JNS007ER-JPN-S31 and whose ratio of treatment to the evaluation at 2 weeks is ≥75% Exclusion Criteria: Patients diagnosed with a mental disease other than schizophrenia A total PANSS score > 120 at baseline Substance-related disorders Parkinson's disease complications Current or a past history of convulsive disease such as epilepsy Current or a past history of cerebrovascular accident Diabetes mellitus Significant hepatic or renal impairment Significant cardiovascular disorders Abnormal results of hematological examination, blood chemistry test and urinalysis at screening Pregnant women, breast-feeding mothers, and patients who wish pregnancy during the study period or those whose pregnancy test at screening was positive Contraindications to risperidone products Patients who discontinued Study JNS007ER-JPN-S31 due to an adverse event not related to the underlying disease Patients judged inadequate by the investigator to participate in the study
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Janssen Pharmaceutical K.K., Japan Clinical Trial
    Organizational Affiliation
    Janssen Pharmaceutical K.K.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    A Long-Term Study of JNS007ER in Patients With Schizophrenia

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