Trial Outcomes & Findings for Comparison of Paliperidone Palmitate and RISPERDAL CONSTA in Patients With Schizophrenia (NCT NCT00589914)
NCT ID: NCT00589914
Last Updated: 2014-06-24
Results Overview
The PANSS scale is used to assess the neuropsychiatric symptoms of schizophrenia. The 30-item PANSS scale provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items),and the general psychopathology subscale (16 items), each item rated on a scale of 1 (absent) to 7 (extreme).
COMPLETED
PHASE3
1221 participants
Baseline to the last postrandomization assessment in the double-blind treatment period (approximately 13 weeks)
2014-06-24
Participant Flow
This is a 13 week double-blind study to assess safety and efficacy of flexible dose of Paliperidone Palmitate (50, 100 or 150 mg equivalent) in patients aged 18 years or older with schizophrenia.
In this study 1221 patients were enrolled of which 1220 patients were randomized as 1 patient was enrolled twice. Only the first patient number was included in the all randomized patients, safety, and intent to treat analysis sets. Out of 1220 patients 1214 patients received at least 1 dose of study medication.
Participant milestones
| Measure |
R092670
Double-blind period. Flexible dose of 50, 100 or 150 mg equivalent administered by i.m. injection every 4 weeks up to Week 9 (Day 64).
|
RISPERDAL CONSTA
Double-blind period. Flexible dose of 25, 37.5 or 50 mg administered by i.m. injection every 2 weeks up to Week 11 (Day 78).
|
|---|---|---|
|
Overall Study
STARTED
|
606
|
608
|
|
Overall Study
COMPLETED
|
456
|
471
|
|
Overall Study
NOT COMPLETED
|
150
|
137
|
Reasons for withdrawal
| Measure |
R092670
Double-blind period. Flexible dose of 50, 100 or 150 mg equivalent administered by i.m. injection every 4 weeks up to Week 9 (Day 64).
|
RISPERDAL CONSTA
Double-blind period. Flexible dose of 25, 37.5 or 50 mg administered by i.m. injection every 2 weeks up to Week 11 (Day 78).
|
|---|---|---|
|
Overall Study
Adverse Event
|
19
|
10
|
|
Overall Study
Death
|
2
|
0
|
|
Overall Study
Lack of Efficacy
|
40
|
43
|
|
Overall Study
Lost to Follow-up
|
11
|
18
|
|
Overall Study
Pregnancy
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
55
|
49
|
|
Overall Study
Other
|
22
|
17
|
Baseline Characteristics
Comparison of Paliperidone Palmitate and RISPERDAL CONSTA in Patients With Schizophrenia
Baseline characteristics by cohort
| Measure |
R092670
n=606 Participants
Double-blind period. Flexible dose of 50, 100 or 150 mg equivalent administered by i.m. injection every 4 weeks up to Week 9 (Day 64).
|
RISPERDAL CONSTA
n=608 Participants
Double-blind period. Flexible dose of 25, 37.5 or 50 mg administered by i.m. injection every 2 weeks up to Week 11 (Day 78).
|
Total
n=1214 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
596 Participants
n=5 Participants
|
599 Participants
n=7 Participants
|
1195 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Continuous
|
39 years
STANDARD_DEVIATION 12.13 • n=5 Participants
|
38.7 years
STANDARD_DEVIATION 11.83 • n=7 Participants
|
38.9 years
STANDARD_DEVIATION 11.98 • n=5 Participants
|
|
Sex: Female, Male
Female
|
245 Participants
n=5 Participants
|
268 Participants
n=7 Participants
|
513 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
361 Participants
n=5 Participants
|
340 Participants
n=7 Participants
|
701 Participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Bulgaria
|
15 participants
n=5 Participants
|
14 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
50 participants
n=5 Participants
|
48 participants
n=7 Participants
|
98 participants
n=5 Participants
|
|
Region of Enrollment
Estonia
|
32 participants
n=5 Participants
|
34 participants
n=7 Participants
|
66 participants
n=5 Participants
|
|
Region of Enrollment
France
|
7 participants
n=5 Participants
|
3 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
31 participants
n=5 Participants
|
34 participants
n=7 Participants
|
65 participants
n=5 Participants
|
|
Region of Enrollment
India
|
31 participants
n=5 Participants
|
31 participants
n=7 Participants
|
62 participants
n=5 Participants
|
|
Region of Enrollment
Lithuania
|
17 participants
n=5 Participants
|
20 participants
n=7 Participants
|
37 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
24 participants
n=5 Participants
|
20 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
159 participants
n=5 Participants
|
159 participants
n=7 Participants
|
318 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
17 participants
n=5 Participants
|
17 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
84 participants
n=5 Participants
|
84 participants
n=7 Participants
|
168 participants
n=5 Participants
|
|
Region of Enrollment
United States of America
|
132 participants
n=5 Participants
|
137 participants
n=7 Participants
|
269 participants
n=5 Participants
|
|
AgeCategorical
18-25 years
|
103 participants
n=5 Participants
|
92 participants
n=7 Participants
|
195 participants
n=5 Participants
|
|
AgeCategorical
26-50 years
|
381 participants
n=5 Participants
|
397 participants
n=7 Participants
|
778 participants
n=5 Participants
|
|
AgeCategorical
51-65 years
|
115 participants
n=5 Participants
|
113 participants
n=7 Participants
|
228 participants
n=5 Participants
|
|
AgeCategorical
>65 years
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
AgeCategorical
<18 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to the last postrandomization assessment in the double-blind treatment period (approximately 13 weeks)Population: The per-protocol analysis set of patients included those randomized to treatment after IEC/ IRB approval of protocol Amendment INT-4 with both a baseline measurement and at least 1 postrandomization measurement on the primary efficacy variable, a minimum exposure of 36 days to the double-blind treatment regimen, and no major protocol violations.
The PANSS scale is used to assess the neuropsychiatric symptoms of schizophrenia. The 30-item PANSS scale provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items),and the general psychopathology subscale (16 items), each item rated on a scale of 1 (absent) to 7 (extreme).
Outcome measures
| Measure |
R092670
n=389 Participants
Double-blind period. Flexible dose of 50, 100 or 150 mg equivalent administered by i.m. injection every 4 weeks up to Week 9 (Day 64).
|
RISPERDAL CONSTA
n=376 Participants
Double-blind period. Flexible dose of 25, 37.5 or 50 mg administered by i.m. injection every 2 weeks up to Week 11 (Day 78).
|
|---|---|---|
|
Change in the Positive and Negative Syndrome Scale (PANSS) Total Score for Schizophrenia
|
-18.6 Scores on a scale
Standard Deviation 15.45
|
-17.9 Scores on a scale
Standard Deviation 14.24
|
SECONDARY outcome
Timeframe: Baseline to the last postrandomization assessment in the double-blind treatment period (approximately 13 weeks)]Population: The intent-to-treat (ITT) analysis set of patients included those randomized to treatment after IEC/IRB approval of protocol Amendment INT-4 who received at least 1 injection of double-blind study drug and had at least 1 efficacy measurement during the double-blind treatment period.
The CGI-S rating scale is used to rate the severity of a patient's psychotic condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe). This scale permits a global evaluation of the patient's condition at a given time. A qualified rater administered the CGI-S.
Outcome measures
| Measure |
R092670
n=453 Participants
Double-blind period. Flexible dose of 50, 100 or 150 mg equivalent administered by i.m. injection every 4 weeks up to Week 9 (Day 64).
|
RISPERDAL CONSTA
n=460 Participants
Double-blind period. Flexible dose of 25, 37.5 or 50 mg administered by i.m. injection every 2 weeks up to Week 11 (Day 78).
|
|---|---|---|
|
The Change From Baseline for the CGI-S Score
|
-0.9 Scores on a scale
Standard Deviation 0.97
|
-0.9 Scores on a scale
Standard Deviation 0.93
|
SECONDARY outcome
Timeframe: Baseline to the last postrandomization assessment in the double-blind treatment period (approximately 13 weeks)Population: The intent-to-treat (ITT) analysis set of patients included those randomized to treatment after IEC/IRB approval of protocol Amendment INT-4 who received at least 1 injection of double-blind study drug and had at least 1 efficacy measurement during the double-blind treatment period.
The PSP scale is used to assess the degree of dysfunction a patient exhibits over a 7-day period within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The results of the assessment are converted to a numeric score. A score between 71 and 100 indicates a mild degree of difficulty; a score between 31 and 70 indicates a moderate degree of dysfunction, and a patient with a score of 30 or less has functioning so poor he or she requires intensive supervision.
Outcome measures
| Measure |
R092670
n=448 Participants
Double-blind period. Flexible dose of 50, 100 or 150 mg equivalent administered by i.m. injection every 4 weeks up to Week 9 (Day 64).
|
RISPERDAL CONSTA
n=452 Participants
Double-blind period. Flexible dose of 25, 37.5 or 50 mg administered by i.m. injection every 2 weeks up to Week 11 (Day 78).
|
|---|---|---|
|
The Change From Baseline in the PSP Score
|
8.5 Scores on a scale
Standard Deviation 11.82
|
8.8 Scores on a scale
Standard Deviation 11.65
|
Adverse Events
R092670
RISPERDAL CONSTA
Serious adverse events
| Measure |
R092670
n=606 participants at risk
Double-blind period. Flexible dose of 50, 100 or 150 mg equivalent administered by i.m. injection every 4 weeks up to Week 9 (Day 64).
|
RISPERDAL CONSTA
n=608 participants at risk
Double-blind period. Flexible dose of 25, 37.5 or 50 mg administered by i.m. injection every 2 weeks up to Week 11 (Day 78).
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/606
|
0.16%
1/608
|
|
Gastrointestinal disorders
Volvulus of small bowel
|
0.00%
0/606
|
0.16%
1/608
|
|
General disorders
Death
|
0.17%
1/606
|
0.00%
0/608
|
|
Infections and infestations
Malaria
|
0.00%
0/606
|
0.16%
1/608
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/606
|
0.16%
1/608
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/606
|
0.16%
1/608
|
|
Nervous system disorders
Syncope
|
0.00%
0/606
|
0.16%
1/608
|
|
Psychiatric disorders
Agitation
|
0.33%
2/606
|
0.33%
2/608
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/606
|
0.16%
1/608
|
|
Psychiatric disorders
Anxiety
|
0.33%
2/606
|
0.00%
0/608
|
|
Psychiatric disorders
Completed suicide
|
0.17%
1/606
|
0.00%
0/608
|
|
Psychiatric disorders
Delirium
|
0.00%
0/606
|
0.16%
1/608
|
|
Psychiatric disorders
Delusion
|
0.17%
1/606
|
0.00%
0/608
|
|
Psychiatric disorders
Depressive symptom
|
0.17%
1/606
|
0.00%
0/608
|
|
Psychiatric disorders
Hallucination
|
0.17%
1/606
|
0.00%
0/608
|
|
Psychiatric disorders
Hallucination, auditory
|
0.17%
1/606
|
0.00%
0/608
|
|
Psychiatric disorders
Hallucination, visual
|
0.17%
1/606
|
0.00%
0/608
|
|
Psychiatric disorders
Paranoia
|
0.50%
3/606
|
0.16%
1/608
|
|
Psychiatric disorders
Psychotic disorder
|
2.1%
13/606
|
1.2%
7/608
|
|
Psychiatric disorders
Schizophrenia
|
2.5%
15/606
|
2.1%
13/608
|
|
Psychiatric disorders
Schizophrenia, paranoid type
|
0.17%
1/606
|
0.00%
0/608
|
|
Psychiatric disorders
Suicidal ideation
|
0.50%
3/606
|
0.00%
0/608
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/606
|
0.16%
1/608
|
|
Psychiatric disorders
Tension
|
0.17%
1/606
|
0.00%
0/608
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/606
|
0.16%
1/608
|
Other adverse events
| Measure |
R092670
n=606 participants at risk
Double-blind period. Flexible dose of 50, 100 or 150 mg equivalent administered by i.m. injection every 4 weeks up to Week 9 (Day 64).
|
RISPERDAL CONSTA
n=608 participants at risk
Double-blind period. Flexible dose of 25, 37.5 or 50 mg administered by i.m. injection every 2 weeks up to Week 11 (Day 78).
|
|---|---|---|
|
General disorders
Injection site pain
|
5.1%
31/606
|
0.82%
5/608
|
|
Nervous system disorders
Headache
|
7.1%
43/606
|
7.2%
44/608
|
|
Nervous system disorders
Somnolence
|
5.6%
34/606
|
3.9%
24/608
|
|
Psychiatric disorders
Insomnia
|
9.4%
57/606
|
6.7%
41/608
|
Additional Information
Clinical Leader Psychiatry
Johnson & Johnson Pharmaceutical Research & Development LLC
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60