Trial Outcomes & Findings for A Long-Term Study of JNS007ER in Patients With Schizophrenia (NCT NCT01561898)
NCT ID: NCT01561898
Last Updated: 2012-09-28
Results Overview
The incidence of adverse events was measured by the percentage of patients who presented one or more adverse events.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
228 participants
Primary outcome timeframe
48 weeks
Results posted on
2012-09-28
Participant Flow
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).
Participant milestones
| Measure |
NO/PAL Group
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
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
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
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 Study
STARTED
|
7
|
92
|
97
|
32
|
|
Overall Study
COMPLETED
|
5
|
51
|
53
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
41
|
44
|
20
|
Reasons for withdrawal
| Measure |
NO/PAL Group
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
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
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
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 Study
Withdrawal by Subject
|
0
|
8
|
12
|
5
|
|
Overall Study
Lack of Efficacy
|
0
|
8
|
10
|
5
|
|
Overall Study
Worsening of complications
|
0
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
19
|
14
|
9
|
|
Overall Study
Physician Decision
|
1
|
5
|
7
|
1
|
Baseline Characteristics
A Long-Term Study of JNS007ER in Patients With Schizophrenia
Baseline characteristics by cohort
| Measure |
NO/PAL Group
n=7 Participants
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
n=92 Participants
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
n=97 Participants
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
n=32 Participants
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
n=228 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
35.6 years
STANDARD_DEVIATION 14.8 • n=5 Participants
|
46.6 years
STANDARD_DEVIATION 15.5 • n=7 Participants
|
42.0 years
STANDARD_DEVIATION 14.1 • n=5 Participants
|
46.3 years
STANDARD_DEVIATION 14.0 • n=4 Participants
|
44.3 years
STANDARD_DEVIATION 14.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
113 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
115 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 48 weeksPopulation: Intent-to-treat (ITT) population
The incidence of adverse events was measured by the percentage of patients who presented one or more adverse events.
Outcome measures
| Measure |
NO/PAL
n=228 Participants
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
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
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
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.
|
|---|---|---|---|---|
|
Incidence of Adverse Events
|
97.4 percentage of patients
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Intent-to-treat (ITT) population
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).
Outcome measures
| Measure |
NO/PAL
n=7 Participants
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
n=92 Participants
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
n=97 Participants
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
n=32 Participants
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.
|
|---|---|---|---|---|
|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS)
|
-13.4 scores on a scale
Standard Deviation 31.93
|
-11.1 scores on a scale
Standard Deviation 20.84
|
-17.2 scores on a scale
Standard Deviation 22.15
|
2.8 scores on a scale
Standard Deviation 20.67
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Intent-to-treat (ITT) population
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".
Outcome measures
| Measure |
NO/PAL
n=7 Participants
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
n=92 Participants
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
n=97 Participants
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
n=32 Participants
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.
|
|---|---|---|---|---|
|
Change From Baseline in Clinical Global Impression - Severity (CGI-S)
|
-0.6 scores on a scale
Standard Deviation 1.27
|
-0.6 scores on a scale
Standard Deviation 1.20
|
-0.7 scores on a scale
Standard Deviation 1.24
|
0.1 scores on a scale
Standard Deviation 1.01
|
Adverse Events
Entire Group
Serious events: 10 serious events
Other events: 222 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Entire Group
n=228 participants at risk
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.
|
|---|---|
|
Psychiatric disorders
Schizophrenia
|
1.3%
3/228 • 48 weeks
|
|
Infections and infestations
Pneumonia
|
0.88%
2/228 • 48 weeks
|
|
Psychiatric disorders
Insomnia
|
0.44%
1/228 • 48 weeks
|
|
Nervous system disorders
Akathisia
|
0.44%
1/228 • 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary aspiration
|
0.44%
1/228 • 48 weeks
|
|
General disorders
Multiple organ failure
|
0.44%
1/228 • 48 weeks
|
|
Cardiac disorders
ECG corrected QT interval prolonged
|
0.44%
1/228 • 48 weeks
|
|
General disorders
Overdose
|
0.44%
1/228 • 48 weeks
|
Other adverse events
| Measure |
Entire Group
n=228 participants at risk
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.
|
|---|---|
|
Investigations
Blood prolactin increased
|
39.9%
91/228 • 48 weeks
|
|
Infections and infestations
Nasopharyngitis
|
33.8%
77/228 • 48 weeks
|
|
Psychiatric disorders
Schizophrenia
|
30.3%
69/228 • 48 weeks
|
|
General disorders
Weight increased
|
21.9%
50/228 • 48 weeks
|
|
Nervous system disorders
Extrapyramidal disorder
|
17.1%
39/228 • 48 weeks
|
|
Gastrointestinal disorders
Constipation
|
14.0%
32/228 • 48 weeks
|
|
Metabolism and nutrition disorders
Blood triglycerides increased
|
10.1%
23/228 • 48 weeks
|
|
Metabolism and nutrition disorders
Blood creatine phosphokinase increased
|
12.3%
28/228 • 48 weeks
|
|
Psychiatric disorders
Insomnia
|
10.1%
23/228 • 48 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema
|
8.8%
20/228 • 48 weeks
|
|
Gastrointestinal disorders
Dental caries
|
7.0%
16/228 • 48 weeks
|
|
Nervous system disorders
Headache
|
6.6%
15/228 • 48 weeks
|
|
General disorders
Fever
|
6.6%
15/228 • 48 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
6.1%
14/228 • 48 weeks
|
|
Gastrointestinal disorders
Vomiting
|
6.1%
14/228 • 48 weeks
|
|
Hepatobiliary disorders
Abnormal hepatic function
|
6.1%
14/228 • 48 weeks
|
|
Musculoskeletal and connective tissue disorders
Backache
|
5.7%
13/228 • 48 weeks
|
|
Metabolism and nutrition disorders
Blood cholesterol increased
|
5.7%
13/228 • 48 weeks
|
|
Skin and subcutaneous tissue disorders
Abrasion
|
5.7%
13/228 • 48 weeks
|
Additional Information
Medical Director
Janssen Pharm KK Japan
Phone: 03-4411-5067
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER