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A Long-Term Study of JNS007ER in Patients With Schizophrenia

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ClinicalTrials.gov Identifier: NCT01561898
Recruitment Status : Completed
First Posted : March 23, 2012
Results First Posted : September 10, 2012
Last Update Posted : September 28, 2012
Sponsor:
Information provided by:
Janssen Pharmaceutical K.K.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Schizophrenia
Intervention Drug: Paliperidone extended-release (JNS007ER)
Enrollment 228
Recruitment Details This study comprises patients who have participated in previous study JNS007ER-JPN-S31 (NCT00396565) and new patients. New patients were classified as group NO/PAL. Patients entering from study JNS007ER-JPN-S31 were classified according to their origin groups: placebo group (PLA/PAL), paliperidone group (PAL/PAL), and olanzapine group (OLZ/PAL).
Pre-assignment Details  
Arm/Group Title NO/PAL Group PLA/PAL Group PAL/PAL Group OLZ/PAL
Hide Arm/Group Description NO/PAL: group consisting of new patients. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg. PLA/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the placebo group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg. PAL/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the paliperidone ER group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg. OLZ/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the olanzapine group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
Period Title: Overall Study
Started 7 92 97 32
Completed 5 51 53 12
Not Completed 2 41 44 20
Reason Not Completed
Withdrawal by Subject             0             8             12             5
Lack of Efficacy             0             8             10             5
Worsening of complications             0             1             0             0
Lost to Follow-up             0             0             1             0
Adverse Event             1             19             14             9
Physician Decision             1             5             7             1
Arm/Group Title NO/PAL Group PLA/PAL Group PAL/PAL Group OLZ/PAL Total
Hide Arm/Group Description NO/PAL: group consisting of new patients. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg. PLA/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the placebo group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg. PAL/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the paliperidone ER group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg. OLZ/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the olanzapine group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg. Total of all reporting groups
Overall Number of Baseline Participants 7 92 97 32 228
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 92 participants 97 participants 32 participants 228 participants
35.6  (14.8) 46.6  (15.5) 42.0  (14.1) 46.3  (14.0) 44.3  (14.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 92 participants 97 participants 32 participants 228 participants
Female
3
  42.9%
44
  47.8%
46
  47.4%
20
  62.5%
113
  49.6%
Male
4
  57.1%
48
  52.2%
51
  52.6%
12
  37.5%
115
  50.4%
1.Primary Outcome
Title Incidence of Adverse Events
Hide Description The incidence of adverse events was measured by the percentage of patients who presented one or more adverse events.
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population
Arm/Group Title Entire Group
Hide Arm/Group Description:
Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
Overall Number of Participants Analyzed 228
Measure Type: Number
Unit of Measure: percentage of patients
97.4
2.Secondary Outcome
Title Change From Baseline in Positive and Negative Syndrome Scale (PANSS)
Hide Description 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).
Time Frame Baseline, Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population
Arm/Group Title NO/PAL PLA/PAL Group PAL/PAL Group OLZ/PAL
Hide Arm/Group Description:
NO/PAL: group consisting of new patients. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
PLA/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the placebo group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
PAL/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the paliperidone ER group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
OLZ/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the olanzapine group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
Overall Number of Participants Analyzed 7 92 97 32
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-13.4  (31.93) -11.1  (20.84) -17.2  (22.15) 2.8  (20.67)
3.Secondary Outcome
Title Change From Baseline in Clinical Global Impression - Severity (CGI-S)
Hide Description 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".
Time Frame Baseline, Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population
Arm/Group Title NO/PAL PLA/PAL Group PAL/PAL Group OLZ/PAL
Hide Arm/Group Description:
NO/PAL: group consisting of new patients. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
PLA/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the placebo group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
PAL/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the paliperidone ER group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
OLZ/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the olanzapine group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
Overall Number of Participants Analyzed 7 92 97 32
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.6  (1.27) -0.6  (1.20) -0.7  (1.24) 0.1  (1.01)
Time Frame 48 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Entire Group
Hide Arm/Group Description Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
All-Cause Mortality
Entire Group
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Entire Group
Affected / at Risk (%)
Total   10/228 (4.39%) 
Cardiac disorders   
ECG corrected QT interval prolonged * 1  1/228 (0.44%) 
General disorders   
Multiple organ failure * 1  1/228 (0.44%) 
Overdose * 1  1/228 (0.44%) 
Infections and infestations   
Pneumonia * 1  2/228 (0.88%) 
Nervous system disorders   
Akathisia * 1  1/228 (0.44%) 
Psychiatric disorders   
Schizophrenia * 1  3/228 (1.32%) 
Insomnia * 1  1/228 (0.44%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary aspiration * 1  1/228 (0.44%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA/J(Ver.10.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Entire Group
Affected / at Risk (%)
Total   222/228 (97.37%) 
Gastrointestinal disorders   
Constipation * 1  32/228 (14.04%) 
Dental caries * 1  16/228 (7.02%) 
Diarrhea * 1  14/228 (6.14%) 
Vomiting * 1  14/228 (6.14%) 
General disorders   
Weight increased * 1  50/228 (21.93%) 
Fever * 1  15/228 (6.58%) 
Hepatobiliary disorders   
Abnormal hepatic function * 1  14/228 (6.14%) 
Infections and infestations   
Nasopharyngitis * 1  77/228 (33.77%) 
Investigations   
Blood prolactin increased * 1  91/228 (39.91%) 
Metabolism and nutrition disorders   
Blood triglycerides increased * 1  23/228 (10.09%) 
Blood creatine phosphokinase increased * 1  28/228 (12.28%) 
Blood cholesterol increased * 1  13/228 (5.70%) 
Musculoskeletal and connective tissue disorders   
Backache * 1  13/228 (5.70%) 
Nervous system disorders   
Extrapyramidal disorder * 1  39/228 (17.11%) 
Headache * 1  15/228 (6.58%) 
Psychiatric disorders   
Schizophrenia * 1  69/228 (30.26%) 
Insomnia * 1  23/228 (10.09%) 
Skin and subcutaneous tissue disorders   
Eczema * 1  20/228 (8.77%) 
Abrasion * 1  13/228 (5.70%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA/J(Ver.10.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The disclosure restriction on PI is that the sponsor can review results communications prior to public release and can embargo communications regarding results for a period as the sponsor requires.
Results Point of Contact
Name/Title: Medical Director
Organization: Janssen Pharm KK Japan
Phone: 03-4411-5067
Responsible Party: Medical Director, Janssen Pharmaceutical K.K., Japan
ClinicalTrials.gov Identifier: NCT01561898     History of Changes
Other Study ID Numbers: CR012628
JNS007ER-JPN-S32 ( Other Identifier: Janssen Pharmaceutical K.K., Japan )
First Submitted: March 22, 2012
First Posted: March 23, 2012
Results First Submitted: August 8, 2012
Results First Posted: September 10, 2012
Last Update Posted: September 28, 2012