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Efficacy and Safety of A-prexa Compared to Zyprexa in Patients With Schizophrenia

Primary Purpose

Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
A-prexa
Zyprexa
Sponsored by
HK inno.N Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 20 years to 65 years
  • Schizophrenia patient with an acute exacerbation
  • Understand the requirement of the study and voluntarily consent to participate in the study

Exclusion Criteria:

  • Patients who have another psychiatric disorders
  • Patients who have unstable medical conditions
  • Patients who have clinically important abnormalities of liver function test (>2.5 fold of upper normal limit), ECG and vital sign at screening visit
  • Uncontrolled diabetic patients (plasma glucose level is more than 126 mg/dl in fasting condition)
  • Patients who have a history of an allergic reaction to olanzapine
  • Patient who have no clinical response to take two or more different atypical anti-psychotics for more than 4 weeks.
  • Patient who take clozapine within 12 weeks before screening visit

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    A-prexa

    Zyprexa

    Arm Description

    A-prexa 5, 10mg

    Zyprexa 5, 10mg

    Outcomes

    Primary Outcome Measures

    Change from baseline at 6 week in total PANSS score

    Secondary Outcome Measures

    Change from baseline at 1, 2, 4 and 6 week in total PANSS score.
    Responder to be decreased of 30% or more in PANSS total score from baseline at 6 week
    Change from baseline at 6 week in total CGI-S score
    Responder rate in CGI-I score of 'very much improved', 'much improved' and 'minimally improved'

    Full Information

    First Posted
    May 11, 2014
    Last Updated
    May 11, 2014
    Sponsor
    HK inno.N Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02137993
    Brief Title
    Efficacy and Safety of A-prexa Compared to Zyprexa in Patients With Schizophrenia
    Official Title
    A Multi-center, Randomized, Double Blind, Parallel, PhaseⅣ Trial to Evaluate the Efficacy and Safety of A-prexa Compared to Zyprexa in Patients With Schizophrenia, Schizophreniform Disorder and Schizoaffective Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2012 (undefined)
    Primary Completion Date
    May 2013 (Actual)
    Study Completion Date
    May 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    HK inno.N Corporation

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the efficacy and safety of A-prexa compared to Zyprexa in patients with schizophrenia, schizophreniform disorder and schizoaffective disorder.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    64 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    A-prexa
    Arm Type
    Experimental
    Arm Description
    A-prexa 5, 10mg
    Arm Title
    Zyprexa
    Arm Type
    Active Comparator
    Arm Description
    Zyprexa 5, 10mg
    Intervention Type
    Drug
    Intervention Name(s)
    A-prexa
    Intervention Description
    A-prexa 5-20 mg for 6 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Zyprexa
    Intervention Description
    Zyprexa 5-20 mg for 6 weeks
    Primary Outcome Measure Information:
    Title
    Change from baseline at 6 week in total PANSS score
    Time Frame
    6 week
    Secondary Outcome Measure Information:
    Title
    Change from baseline at 1, 2, 4 and 6 week in total PANSS score.
    Time Frame
    6 week
    Title
    Responder to be decreased of 30% or more in PANSS total score from baseline at 6 week
    Time Frame
    6 week
    Title
    Change from baseline at 6 week in total CGI-S score
    Time Frame
    6 week
    Title
    Responder rate in CGI-I score of 'very much improved', 'much improved' and 'minimally improved'
    Time Frame
    6 week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 20 years to 65 years Schizophrenia patient with an acute exacerbation Understand the requirement of the study and voluntarily consent to participate in the study Exclusion Criteria: Patients who have another psychiatric disorders Patients who have unstable medical conditions Patients who have clinically important abnormalities of liver function test (>2.5 fold of upper normal limit), ECG and vital sign at screening visit Uncontrolled diabetic patients (plasma glucose level is more than 126 mg/dl in fasting condition) Patients who have a history of an allergic reaction to olanzapine Patient who have no clinical response to take two or more different atypical anti-psychotics for more than 4 weeks. Patient who take clozapine within 12 weeks before screening visit

    12. IPD Sharing Statement

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    Efficacy and Safety of A-prexa Compared to Zyprexa in Patients With Schizophrenia

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