A Long-Term Study of JNS007ER in Patients With Schizophrenia

This study has been completed.
Sponsor:
Information provided by:
Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier:
NCT01561898
First received: March 22, 2012
Last updated: September 14, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Drug: Paliperidone extended-release (JNS007ER)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Long-Term 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:
  • Incidence of Adverse Events [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    The incidence of adverse events was measured by the percentage of patients who presented one or more adverse events.


Secondary Outcome Measures:
  • Change From Baseline in Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Baseline, Week 48 ] [ Designated as safety issue: No ]
    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 - Severity (CGI-S) [ Time Frame: Baseline, Week 48 ] [ Designated as safety issue: No ]
    The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill patients".


Enrollment: 228
Study Start Date: June 2006
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paliperidone extended-release (JNS007ER) Drug: 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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01561898

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

No publications provided

Responsible Party: Medical Director, Janssen Pharmaceutical K.K., Japan
ClinicalTrials.gov Identifier: NCT01561898     History of Changes
Other Study ID Numbers: CR012628, JNS007ER-JPN-S32
Study First Received: March 22, 2012
Results First Received: August 8, 2012
Last Updated: September 14, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Janssen Pharmaceutical K.K.:
Schizophrenia
JNS007ER
Paliperidone extended-release

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
9-hydroxy-risperidone
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 29, 2014