A Long-Term Study of JNS007ER in Patients With Schizophrenia

NCT01561898 | Completed Phase 3 Results

• 2 other identifiers: CR012628JNS007ER-JPN-S32
• Study Type: interventional
• Target: 228
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Schizophrenia

Keywords

Schizophrenia; JNS007ER; Paliperidone extended-release

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events

  The incidence of adverse events was measured by the percentage of patients who presented one or more adverse events.

  48 weeks

Secondary Outcomes (2)

• Change From Baseline in Positive and Negative Syndrome Scale (PANSS)

  Baseline, Week 48

• Change From Baseline in Clinical Global Impression - Severity (CGI-S)

  Baseline, Week 48

Study Arms (1)

Paliperidone extended-release (JNS007ER)

EXPERIMENTAL

Drug: Paliperidone extended-release (JNS007ER)

Interventions

Paliperidone extended-release (JNS007ER) 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.

Paliperidone extended-release (JNS007ER)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Medical Director
• Organization: Janssen Pharm KK Japan

03-4411-5067

Study Officials

• Janssen Pharmaceutical K.K., Japan Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 22, 2012
• First Posted: March 23, 2012
• Study Start: June 1, 2006
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: September 28, 2012
• Results First Posted: September 10, 2012

Record last verified: 2012-09