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A Long-Term Study of JNS007ER in Patients With Schizophrenia

NCT ID: NCT01561898

Last Updated: 2012-09-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

228 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2008-10-31

Brief Summary

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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

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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.

Conditions

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Schizophrenia

Keywords

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Schizophrenia JNS007ER Paliperidone extended-release

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Paliperidone extended-release (JNS007ER)

Group Type EXPERIMENTAL

Paliperidone extended-release (JNS007ER)

Intervention Type DRUG

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.

Interventions

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Paliperidone extended-release (JNS007ER)

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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Pharmaceutical K.K.

INDUSTRY

Sponsor Role lead

Responsible Party

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Janssen Pharmaceutical K.K., Japan

Principal Investigators

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Janssen Pharmaceutical K.K., Japan Clinical Trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutical K.K.

Other Identifiers

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JNS007ER-JPN-S32

Identifier Type: OTHER

Identifier Source: secondary_id

CR012628

Identifier Type: -

Identifier Source: org_study_id