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A Study to Evaluate Effectiveness and Safety of ER OROS Paliperidone in Patients With Schizophrenia
This study has been completed.
First Received: November 3, 2006   Last Updated: January 23, 2009   History of Changes
Sponsored by: Janssen Pharmaceutical K.K.
Information provided by: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT00396565
  Purpose

The purpose of this study is to evaluate the effectiveness and safety of ER OROS Paliperidone compared to placebo in patients with Schizophrenia. Olanzapine will be used compared as a reference drug in the study.


Condition Intervention Phase
Schizophrenia
Drug: JNS007ER
Drug: Olanzapine
Drug: Placebo
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title: A Placebo-Controlled Double Blind Comparative Study of JNS007ER in Patients With Schizophrenia

Resource links provided by NLM:


Further study details as provided by Janssen Pharmaceutical K.K.:

Primary Outcome Measures:
  • The primary endpoint in this study is to be the change from baseline in total PANSS score. The primary evaluation time is to be at the final evaluation (when the evaluation was conducted finally in the subjects, i.e., at 6 weeks in LOCF data). [ Time Frame: From baseline to the final evaluation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 1) Proportion of responders 2) PANSS subscale score (positive symptoms, negative symptoms, general psychopathology, disorganized thoughts, hostility/ excitement, anxiety/ depression) 3) CGI-S [ Time Frame: From baseline to the final evaluation ] [ Designated as safety issue: Yes ]

Enrollment: 394
Study Start Date: June 2006
Study Completion Date: November 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
001: Experimental Drug: JNS007ER
two JNS007ER 3 mg tablets (two capsules) once daily for 6 weeks
002: Placebo Comparator Drug: Placebo
two placebo tablets (two capsules) once daily for 6 weeks
003: Active Comparator Drug: Olanzapine
four olanzapine 2.5 mg tablets (two capsules) once daily for 6 weeks

Detailed Description:

This is a multicenter, double blind (nether 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. Subjects will be randomized into 1 of 3 treatment groups to receive oral dosages of ER OROS paliperidone 6 mg, olanzapine 10 mg, or placebo once daily for a 6-week period. The study will include a screening period, followed by double-blind treatment for 6 weeks. Following the double-blind treatment phase, eligible subjects (those who have completed the 6-week double-blind phase or who discontinue due to lack of efficacy after a minimum of 14 days) may enter the 48-week open-label extension with ER OROS paliperidone therapy. A post-study visit for collection of additional safety data will be scheduled for 1 week after a subject's final dose of study drug, either following the double-blind phase for those subjects not continuing into the open-label extension, or following the open-label extension. For all subjects exiting the study - whether they are withdrawn early from either phase, or complete the double blind and/or open-label phase

  • the investigator will make every effort to see that patients receive an adequate continuity of care.

The Patients will receive two capsules of Paliperidone ER 3 mg, placebo or Olanzapine 5 mg once daily after breakfast for 6 weeks.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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) 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00396565

Sponsors and Collaborators
Janssen Pharmaceutical K.K.
Investigators
Study Director: Janssen Pharmaceutical K.K. Clinical Trial Janssen Pharmaceutical K.K.
  More Information

Additional Information:
No publications provided

Responsible Party: Janssen Pharmaceutical K.K. ( Director of Clinical R&D Dept.3 )
Study ID Numbers: CR012625, JNS007ER-JPN-S31
Study First Received: November 3, 2006
Last Updated: January 23, 2009
ClinicalTrials.gov Identifier: NCT00396565     History of Changes
Health Authority: Japan: Japan Pharmaceuticals And Medical Devices Evaluation Center

Keywords provided by Janssen Pharmaceutical K.K.:
JNS007ER
Positive and negative Syndrome Scale(PANSS)
Schizophrenia
Paliperidone

Study placed in the following topic categories:
Neurotransmitter Agents
Tranquilizing Agents
Olanzapine
Risperidone
Psychotropic Drugs
Antiemetics
Central Nervous System Depressants
9-hydroxy-risperidone
Antipsychotic Agents
Serotonin Uptake Inhibitors
Serotonin
Schizophrenia
Mental Disorders
Psychotic Disorders
Peripheral Nervous System Agents
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Gastrointestinal Agents
Olanzapine
Psychotropic Drugs
Antiemetics
Central Nervous System Depressants
9-hydroxy-risperidone
Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Schizophrenia
Serotonin Agents
Autonomic Agents
Mental Disorders
Therapeutic Uses
Peripheral Nervous System Agents
Central Nervous System Agents
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on September 01, 2009