A Long-Term Study of JNS007ER in Patients With Schizophrenia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01561898|
Recruitment Status : Completed
First Posted : March 23, 2012
Results First Posted : September 10, 2012
Last Update Posted : September 28, 2012
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: Paliperidone extended-release (JNS007ER)||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||228 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Long-Term Study of JNS007ER in Patients With Schizophrenia|
|Study Start Date :||June 2006|
|Primary Completion Date :||October 2008|
|Study Completion Date :||October 2008|
|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.
- Incidence of Adverse Events [ Time Frame: 48 weeks ]The incidence of adverse events was measured by the percentage of patients who presented one or more adverse events.
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Baseline, Week 48 ]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 ]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".
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01561898
|Study Director:||Janssen Pharmaceutical K.K., Japan Clinical Trial||Janssen Pharmaceutical K.K.|