Trial Outcomes & Findings for A Study to Evaluate Effectiveness and Safety of ER OROS Paliperidone in Patients With Schizophrenia (NCT NCT00396565)
NCT ID: NCT00396565
Last Updated: 2014-04-29
Results Overview
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).
COMPLETED
PHASE3
394 participants
Baseline and 6 weeks
2014-04-29
Participant Flow
Informed Consent was obtained from 394 patients. The actual number of patients randomized in the study was 321. 2 subjects discontinued before treatment. 319 subjects were treated and analyzed for safety. 318 subjects were analyzed for baseline characteristics and efficacy.
Participant milestones
| Measure |
Paliperidone Extended Release (ER) (JNS007ER)
Two paliperidone ER (JNS007ER) 3 mg tablets once daily for 6 weeks
|
Placebo
Two placebo tablets once daily for 6 weeks
|
Olanzapine
Four olanzapine 2.5 mg tablets once daily for 6 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
136
|
138
|
47
|
|
Overall Study
COMPLETED
|
88
|
47
|
30
|
|
Overall Study
NOT COMPLETED
|
48
|
91
|
17
|
Reasons for withdrawal
| Measure |
Paliperidone Extended Release (ER) (JNS007ER)
Two paliperidone ER (JNS007ER) 3 mg tablets once daily for 6 weeks
|
Placebo
Two placebo tablets once daily for 6 weeks
|
Olanzapine
Four olanzapine 2.5 mg tablets once daily for 6 weeks
|
|---|---|---|---|
|
Overall Study
Physician Decision
|
3
|
1
|
2
|
|
Overall Study
Adverse Event
|
5
|
13
|
3
|
|
Overall Study
Withdrawal by Subject
|
8
|
13
|
1
|
|
Overall Study
Lack of Efficacy
|
32
|
64
|
11
|
Baseline Characteristics
A Study to Evaluate Effectiveness and Safety of ER OROS Paliperidone in Patients With Schizophrenia
Baseline characteristics by cohort
| Measure |
Paliperidone Extended Release (ER) (JNS007ER)
n=134 Participants
Two paliperidone ER (JNS007ER) 3 mg tablets once daily for 6 weeks
|
Placebo
n=138 Participants
Two placebo tablets once daily for 6 weeks
|
Olanzapine
n=46 Participants
Four olanzapine 2.5 mg tablets once daily for 6 weeks
|
Total
n=318 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
44.0 years
STANDARD_DEVIATION 14.7 • n=5 Participants
|
46.2 years
STANDARD_DEVIATION 15.1 • n=7 Participants
|
46.2 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
45.3 years
STANDARD_DEVIATION 14.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
157 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
161 Participants
n=4 Participants
|
|
Total Positive and Negative Syndrome Scale (PANSS) score
|
92.0 scores on a scale
STANDARD_DEVIATION 12.9 • n=5 Participants
|
91.0 scores on a scale
STANDARD_DEVIATION 11.2 • n=7 Participants
|
94.1 scores on a scale
STANDARD_DEVIATION 12.6 • n=5 Participants
|
91.9 scores on a scale
STANDARD_DEVIATION 12.2 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 weeksPopulation: Full Analysis Set excludes subjects who didn't receive test drug or didn't have post-treatment efficacy data. The Olanzapine (OLZ) group was set as an active drug group to examine clinical position of paliperidone (PAL) ER, and the superiority or non-inferiority of PAL ER 6mg to OLZ 10mg wasn't verified. LOCF imputation method was applied.
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 |
Paliperidone Extended Release (ER) (JNS007ER)
n=134 Participants
Two paliperidone ER (JNS007ER) 3 mg tablets once daily for 6 weeks
|
Placebo
n=138 Participants
Two placebo tablets once daily for 6 weeks
|
Olanzapine
n=46 Participants
Four olanzapine 2.5 mg tablets once daily for 6 weeks
|
|---|---|---|---|
|
Change From Baseline in the Total Positive and Negative Syndrome Scale (PANSS).
|
-9.1 scores on a scale
Standard Deviation 18.39
|
3.8 scores on a scale
Standard Deviation 18.88
|
-9.9 scores on a scale
Standard Deviation 16.83
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksPopulation: Full Analysis Set excludes subjects who didn't receive test drug or didn't have post-treatment efficacy data. The Olanzapine(OLZ) group was set as an active drug group to examine clinical position of paliperidone(PAL) ER, and the superiority or non-inferiority of PAL ER 6mg to OLZ 10mg wasn't verified. LOCF imputation method was applied.
The PANSS Positive Subscale assesses seven positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).
Outcome measures
| Measure |
Paliperidone Extended Release (ER) (JNS007ER)
n=134 Participants
Two paliperidone ER (JNS007ER) 3 mg tablets once daily for 6 weeks
|
Placebo
n=138 Participants
Two placebo tablets once daily for 6 weeks
|
Olanzapine
n=46 Participants
Four olanzapine 2.5 mg tablets once daily for 6 weeks
|
|---|---|---|---|
|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score
|
-2.6 scores on a scale
Standard Deviation 5.69
|
1.6 scores on a scale
Standard Deviation 5.53
|
-2.4 scores on a scale
Standard Deviation 5.34
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksPopulation: Full Analysis Set excludes subjects who didn't receive test drug or didn't have post-treatment efficacy data. The Olanzapine(OLZ) group was set as an active drug group to examine clinical position of paliperidone(PAL) ER, and the superiority or non-inferiority of PAL ER 6mg to OLZ 10mg wasn't verified. LOCF imputation method was applied.
The PANSS Negative Subscale assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).
Outcome measures
| Measure |
Paliperidone Extended Release (ER) (JNS007ER)
n=134 Participants
Two paliperidone ER (JNS007ER) 3 mg tablets once daily for 6 weeks
|
Placebo
n=138 Participants
Two placebo tablets once daily for 6 weeks
|
Olanzapine
n=46 Participants
Four olanzapine 2.5 mg tablets once daily for 6 weeks
|
|---|---|---|---|
|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score
|
-2.4 scores on a scale
Standard Deviation 5.05
|
0.0 scores on a scale
Standard Deviation 5.02
|
-2.8 scores on a scale
Standard Deviation 4.27
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksPopulation: Full Analysis Set excludes subjects who didn't receive test drug or didn't have post-treatment efficacy data. The Olanzapine(OLZ) group was set as an active drug group to examine clinical position of paliperidone(PAL) ER, and the superiority or non-inferiority of PAL ER 6mg to OLZ 10mg wasn't verified. LOCF imputation method was applied.
The PANSS General Psychopathology Subscale Score assesses 16 general psychopathology symptoms. The symptoms are rated on a 7-point scale, with a range of 16 (absent) to 112 (extreme psychopathology).
Outcome measures
| Measure |
Paliperidone Extended Release (ER) (JNS007ER)
n=134 Participants
Two paliperidone ER (JNS007ER) 3 mg tablets once daily for 6 weeks
|
Placebo
n=138 Participants
Two placebo tablets once daily for 6 weeks
|
Olanzapine
n=46 Participants
Four olanzapine 2.5 mg tablets once daily for 6 weeks
|
|---|---|---|---|
|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score
|
-4.1 scores on a scale
Standard Deviation 9.52
|
2.2 scores on a scale
Standard Deviation 10.71
|
-4.7 scores on a scale
Standard Deviation 9.00
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksPopulation: Full Analysis Set excludes subjects who didn't receive test drug or didn't have post-treatment efficacy data. The Olanzapine(OLZ) group was set as an active drug group to examine clinical position of paliperidone(PAL) ER, and the superiority or non-inferiority of PAL ER 6mg to OLZ 10mg wasn't verified. LOCF imputation method was applied.
Responders are subjects with 30% or more reduction from baseline in total PANSS score. 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 |
Paliperidone Extended Release (ER) (JNS007ER)
n=134 Participants
Two paliperidone ER (JNS007ER) 3 mg tablets once daily for 6 weeks
|
Placebo
n=138 Participants
Two placebo tablets once daily for 6 weeks
|
Olanzapine
n=46 Participants
Four olanzapine 2.5 mg tablets once daily for 6 weeks
|
|---|---|---|---|
|
Proportion of Responders (≥30% Decrease in Total Positive and Negative Syndrome Scale [PANSS])
|
25.4 Percentage of participants
|
9.4 Percentage of participants
|
26.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksPopulation: Full Analysis Set excludes subjects who didn't receive test drug or didn't have post-treatment efficacy data. The Olanzapine(OLZ) group was set as an active drug group to examine clinical position of paliperidone(PAL) ER, and the superiority or non-inferiority of PAL ER 6mg to OLZ 10mg wasn't verified. LOCF imputation method was applied.
The CGI-S rating scale is a 7-point global assessment with scores as follows: 1 - Not ill, 2 - Very Mild, 3 - Mild, 4 - Moderate, 5 - Marked, 6 - Severe, and 7 - Extremely Severe.
Outcome measures
| Measure |
Paliperidone Extended Release (ER) (JNS007ER)
n=134 Participants
Two paliperidone ER (JNS007ER) 3 mg tablets once daily for 6 weeks
|
Placebo
n=138 Participants
Two placebo tablets once daily for 6 weeks
|
Olanzapine
n=46 Participants
Four olanzapine 2.5 mg tablets once daily for 6 weeks
|
|---|---|---|---|
|
Change From Baseline in Clinical Global Impression Scale (CGI-S)
|
-0.4 scores on a scale
Standard Error 0.09
|
0.2 scores on a scale
Standard Error 0.09
|
-0.3 scores on a scale
Standard Error 0.14
|
Adverse Events
Paliperidone Extended Release (ER) (JNS007ER)
Placebo
Olanzapine
Serious adverse events
| Measure |
Paliperidone Extended Release (ER) (JNS007ER)
n=134 participants at risk
Two paliperidone ER (JNS007ER) 3 mg tablets once daily for 6 weeks
|
Placebo
n=138 participants at risk
Two placebo tablets once daily for 6 weeks
|
Olanzapine
n=47 participants at risk
Four olanzapine 2.5 mg tablets once daily for 6 weeks
|
|---|---|---|---|
|
Psychiatric disorders
schizophrenia
|
2.2%
3/134
|
0.72%
1/138
|
2.1%
1/47
|
|
Infections and infestations
pneumonia
|
0.75%
1/134
|
0.00%
0/138
|
0.00%
0/47
|
|
Psychiatric disorders
mood altered
|
0.00%
0/134
|
0.00%
0/138
|
2.1%
1/47
|
Other adverse events
| Measure |
Paliperidone Extended Release (ER) (JNS007ER)
n=134 participants at risk
Two paliperidone ER (JNS007ER) 3 mg tablets once daily for 6 weeks
|
Placebo
n=138 participants at risk
Two placebo tablets once daily for 6 weeks
|
Olanzapine
n=47 participants at risk
Four olanzapine 2.5 mg tablets once daily for 6 weeks
|
|---|---|---|---|
|
Psychiatric disorders
schizophrenia
|
16.4%
22/134
|
42.8%
59/138
|
23.4%
11/47
|
|
Psychiatric disorders
Insomnia
|
11.2%
15/134
|
10.1%
14/138
|
10.6%
5/47
|
|
Infections and infestations
Nasopharyngitis
|
10.4%
14/134
|
8.0%
11/138
|
2.1%
1/47
|
|
Investigations
Blood creatine phosphokinase increased
|
6.7%
9/134
|
5.8%
8/138
|
4.3%
2/47
|
|
Gastrointestinal disorders
Constipation
|
8.2%
11/134
|
1.4%
2/138
|
10.6%
5/47
|
|
Investigations
Weight increased
|
6.0%
8/134
|
0.00%
0/138
|
10.6%
5/47
|
|
Investigations
Blood triglycerides increased
|
6.7%
9/134
|
0.00%
0/138
|
6.4%
3/47
|
|
Nervous system disorders
Extrapyramidal disorder
|
7.5%
10/134
|
0.72%
1/138
|
2.1%
1/47
|
|
Nervous system disorders
Somnolence
|
2.2%
3/134
|
0.72%
1/138
|
17.0%
8/47
|
|
General disorders
Pyrexia
|
3.7%
5/134
|
2.2%
3/138
|
6.4%
3/47
|
|
Investigations
Basophil count increased
|
0.75%
1/134
|
5.8%
8/138
|
0.00%
0/47
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
5.2%
7/134
|
0.72%
1/138
|
2.1%
1/47
|
|
General disorders
Thirst
|
1.5%
2/134
|
1.4%
2/138
|
10.6%
5/47
|
|
Nervous system disorders
Dizziness
|
0.75%
1/134
|
1.4%
2/138
|
6.4%
3/47
|
|
Investigations
White blood cell count increased
|
1.5%
2/134
|
0.72%
1/138
|
6.4%
3/47
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.75%
1/134
|
0.00%
0/138
|
6.4%
3/47
|
|
Cardiac disorders
Tachycardia
|
0.75%
1/134
|
0.00%
0/138
|
6.4%
3/47
|
Additional Information
Director of Clinical R&D Dept. 3
Janssen Pharmaceutical K.K.
Results disclosure agreements
- Principal investigator is a sponsor employee Without prior notification to the sponsor, the PI cannnot dislose trial results and related documents of trials to a third party.
- Publication restrictions are in place
Restriction type: OTHER