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A Study to Evaluate Effectiveness and Safety of ER OROS Paliperidone in Patients With Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
ER OROS paliperidone
Placebo
Olanzapine
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, Positive and Negative Syndrome Scale (PANSS), Paliperidone, Extended Release Osmotic Controlled-Release Oral Delivery System (OROS) paliperidone

Eligibility Criteria

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

Inclusion Criteria:

  • Patients who have given their own consent in writing to participate in the study
  • Patients diagnosed with schizophrenia according to the diagnostic criteria of DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 295.30, 295.10, 295.20, 295.90, 295.60)
  • Patients who have acute symptoms of schizophrenia
  • Both inpatients and outpatients are acceptable

Exclusion Criteria:

  • A DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) of a mental disease diagnosis other than schizophrenia
  • A DSM-IV diagnosis of substance-related disorder (except nicotine dependence and caffeine dependence) within 180 days before the screening test
  • Total PANSS (Positive and Negative Syndrome System) score at the screening test <70 or >120
  • Patients treated with three or more types of antipsychotic within 28 days before the screening test
  • Parkinson's disease (except for those with drug-induced extra pyramidal symptoms)
  • Patients with a complication of or a past history of cerebrovascular accident
  • Patients with a complication of or a past history of diabetes mellitus

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

ER OROS paliperidone

Placebo

Olanzapine

Arm Description

Extended Release (ER) Osmotic Controlled-Release Oral Delivery System (OROS) paliperidone

Outcomes

Primary Outcome Measures

Change From Baseline in the Total 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).

Secondary Outcome Measures

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score
The PANSS Positive Subscale assesses seven positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score
The PANSS Negative Subscale assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score
The PANSS General Psychopathology Subscale Score assesses 16 general psychopathology symptoms. The symptoms are rated on a 7-point scale, with a range of 16 (absent) to 112 (extreme psychopathology).
Proportion of Responders (≥30% Decrease in Total Positive and Negative Syndrome Scale [PANSS])
Responders are subjects with 30% or more reduction from baseline in total PANSS score. 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 Scale (CGI-S)
The CGI-S rating scale is a 7-point global assessment with scores as follows: 1 - Not ill, 2 - Very Mild, 3 - Mild, 4 - Moderate, 5 - Marked, 6 - Severe, and 7 - Extremely Severe.

Full Information

First Posted
November 3, 2006
Last Updated
April 10, 2014
Sponsor
Janssen Pharmaceutical K.K.
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1. Study Identification

Unique Protocol Identification Number
NCT00396565
Brief Title
A Study to Evaluate Effectiveness and Safety of ER OROS Paliperidone in Patients With Schizophrenia
Official Title
A Placebo-Controlled Double Blind Comparative Study of JNS007ER in Patients With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Pharmaceutical K.K.

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effectiveness and safety of Extended Release Osmotic Controlled-Release Oral Delivery System (OROS) Paliperidone compared to placebo in patients with Schizophrenia. Olanzapine will be used as a reference drug in the study.
Detailed Description
This is a multicenter, double blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), randomized (patients are assigned different treatments based on chance), placebo- and active-controlled, parallel-group study. Patients will be randomized into 1 of 3 treatment groups to receive oral dosages of Extended Release (ER) Osmotic Controlled-Release Oral Delivery System (OROS) paliperidone 6 mg, olanzapine 10 mg, or placebo. They will receive two capsules of Paliperidone ER 3 mg, placebo or Olanzapine 5 mg once daily after breakfast for 6 weeks. The study will include a screening period, followed by double-blind treatment for 6 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, JNS007ER, Positive and Negative Syndrome Scale (PANSS), Paliperidone, Extended Release Osmotic Controlled-Release Oral Delivery System (OROS) paliperidone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
394 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ER OROS paliperidone
Arm Type
Experimental
Arm Description
Extended Release (ER) Osmotic Controlled-Release Oral Delivery System (OROS) paliperidone
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Olanzapine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
ER OROS paliperidone
Intervention Description
Type= exact number, unit= mg, number= 3, form= tablet, route= oral use. Two tablets once daily for 6 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Form= tablet, route= oral use. Two tablets once daily for 6 weeks.
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Intervention Description
Type= exact number, unit= mg, number= 2.5, form= tablet, route= oral use. Four tablets once daily for 6 weeks.
Primary Outcome Measure Information:
Title
Change From Baseline in the Total 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 and 6 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score
Description
The PANSS Positive Subscale assesses seven positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).
Time Frame
Baseline and 6 weeks
Title
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score
Description
The PANSS Negative Subscale assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).
Time Frame
Baseline and 6 weeks
Title
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score
Description
The PANSS General Psychopathology Subscale Score assesses 16 general psychopathology symptoms. The symptoms are rated on a 7-point scale, with a range of 16 (absent) to 112 (extreme psychopathology).
Time Frame
Baseline and 6 weeks
Title
Proportion of Responders (≥30% Decrease in Total Positive and Negative Syndrome Scale [PANSS])
Description
Responders are subjects with 30% or more reduction from baseline in total PANSS score. 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 and 6 weeks
Title
Change From Baseline in Clinical Global Impression Scale (CGI-S)
Description
The CGI-S rating scale is a 7-point global assessment with scores as follows: 1 - Not ill, 2 - Very Mild, 3 - Mild, 4 - Moderate, 5 - Marked, 6 - Severe, and 7 - Extremely Severe.
Time Frame
Baseline and 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who have given their own consent in writing to participate in the study Patients diagnosed with schizophrenia according to the diagnostic criteria of DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 295.30, 295.10, 295.20, 295.90, 295.60) Patients who have acute symptoms of schizophrenia Both inpatients and outpatients are acceptable Exclusion Criteria: A DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) of a mental disease diagnosis other than schizophrenia A DSM-IV diagnosis of substance-related disorder (except nicotine dependence and caffeine dependence) within 180 days before the screening test Total PANSS (Positive and Negative Syndrome System) score at the screening test <70 or >120 Patients treated with three or more types of antipsychotic within 28 days before the screening test Parkinson's disease (except for those with drug-induced extra pyramidal symptoms) Patients with a complication of or a past history of cerebrovascular accident Patients with a complication of or a past history of diabetes mellitus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Pharmaceutical K.K. Clinical Trial
Organizational Affiliation
Janssen Pharmaceutical K.K.
Official's Role
Study Director
Facility Information:
City
Aizuwakamatsu
Country
Japan
City
Fujioka
Country
Japan
City
Fujisawa
Country
Japan
City
Fukui
Country
Japan
City
Hadano
Country
Japan
City
Himeji
Country
Japan
City
Hiratsuka
Country
Japan
City
Hiroshima
Country
Japan
City
Ibaraki
Country
Japan
City
Ichikawa
Country
Japan
City
Iida
Country
Japan
City
Inazawa
Country
Japan
City
Itoman
Country
Japan
City
Kaizuka
Country
Japan
City
Kanzaki
Country
Japan
City
Kashihara
Country
Japan
City
Kitakyushu
Country
Japan
City
Kochi
Country
Japan
City
Koushi N/A
Country
Japan
City
Kumamoto
Country
Japan
City
Kurayoshi
Country
Japan
City
Matsudo
Country
Japan
City
Matsusaka
Country
Japan
City
Moriguchi
Country
Japan
City
Morioka
Country
Japan
City
Nagoya
Country
Japan
City
Naha
Country
Japan
City
Nakagami
Country
Japan
City
Nankoku
Country
Japan
City
Nishinomiya
Country
Japan
City
Noda
Country
Japan
City
Numazu
Country
Japan
City
Ohta
Country
Japan
City
Oita
Country
Japan
City
Okinawa
Country
Japan
City
Oyama
Country
Japan
City
Sakai
Country
Japan
City
Sapporo
Country
Japan
City
Takasaki
Country
Japan
City
Takatsuki
Country
Japan
City
Tanba
Country
Japan
City
Togane
Country
Japan
City
Tokyo
Country
Japan
City
Tottori
Country
Japan
City
Toyama
Country
Japan
City
Toyoake
Country
Japan
City
Toyonaka
Country
Japan
City
Tsuyama
Country
Japan
City
Ueda
Country
Japan
City
Urasoe
Country
Japan
City
Uruma
Country
Japan
City
Yanagawa
Country
Japan
City
Yao
Country
Japan
City
Yokkaichi
Country
Japan
City
Yokohama
Country
Japan
City
Yokosuka
Country
Japan

12. IPD Sharing Statement

Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=412&filename=CR012625_CSR.pdf
Description
A Study to Evaluate Efficacy and Safety of ER OROS Paliperidone in Patients With Schizophrenia

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