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Sponsored by: |
Janssen Pharmaceutical K.K. |
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Information provided by: | Janssen Pharmaceutical K.K. |
ClinicalTrials.gov Identifier: | NCT00396565 |
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 |
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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 |
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 |
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001: Experimental |
Drug: JNS007ER
two JNS007ER 3 mg tablets (two capsules) once daily for 6 weeks
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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
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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 Patients will receive two capsules of Paliperidone ER 3 mg, placebo or Olanzapine 5 mg once daily after breakfast for 6 weeks.
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
JNS007ER Positive and negative Syndrome Scale(PANSS) Schizophrenia Paliperidone |
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 |
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 |