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Comparison of Paliperidone Palmitate and RISPERDAL CONSTA in Patients With Schizophrenia

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00589914
First received: December 21, 2007
Last updated: February 3, 2012
Last verified: February 2012
History of Changes
Results First Received: August 30, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Schizophrenia
Interventions: Drug: RISPERDAL CONSTA
Drug: Paliperidone palmitate

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
In this study 1220 participants were randomized out of which 1214 participants recieved at least 1 dose of study medication. One patient was enrolled twice. Only the first patient number was included in the all randomized patients, safety, and intent to treat (ITT) analysis sets. Neither patient was included in the Per-Protocol analysis set.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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

Reporting Groups
  Description
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).

Participant Flow:   Overall Study
    R092670     RISPERDAL CONSTA  
STARTED     606     608  
COMPLETED     456     471  
NOT COMPLETED     150     137  
Adverse Event                 19                 10  
Death                 2                 0  
Lack of Efficacy                 40                 43  
Lost to Follow-up                 11                 18  
Pregnancy                 1                 0  
Withdrawal by Subject                 55                 49  
Other                 22                 17  



  Baseline Characteristics
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Reporting Groups
  Description
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).
Total Total of all reporting groups

Baseline Measures
    R092670     RISPERDAL CONSTA     Total  
Number of Participants  
[units: participants]
 		  606     608     1214  
Age  
[units: participants]
 		     
<=18 years     3     2     5  
Between 18 and 65 years     596     599     1195  
>=65 years     7     7     14  
Age  
[units: years]
Mean ± Standard Deviation 		  39  ± 12.13     38.7  ± 11.83     38.9  ± 11.98  
Gender  
[units: participants]
 		     
Female     245     268     513  
Male     361     340     701  
Region of Enrollment  
[units: participants]
 		     
Austria     3     3     6  
Bulgaria     15     14     29  
Czech Republic     50     48     98  
Estonia     32     34     66  
France     7     3     10  
Germany     4     4     8  
Hungary     31     34     65  
India     31     31     62  
Lithuania     17     20     37  
Poland     24     20     44  
Russia     159     159     318  
Spain     17     17     34  
Ukraine     84     84     168  
United States of America     132     137     269  
AgeCategorical  
[units: participants]
 		     
18-25 years     103     92     195  
26-50 years     381     397     778  
51-65 years     115     113     228  
>65 years     7     6     13  
<18 years     0     0     0  



  Outcome Measures
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1.  Primary:   Change in the Positive and Negative Syndrome Scale (PANSS) Total Score for Schizophrenia   [ Time Frame: Baseline to the last postrandomization assessment in the double-blind treatment period (approximately 13 weeks) ]
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Measure Type Primary
Measure Title Change in the Positive and Negative Syndrome Scale (PANSS) Total Score for Schizophrenia
Measure Description 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).
Time Frame Baseline to the last postrandomization assessment in the double-blind treatment period (approximately 13 weeks)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
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).

Measured Values
    R092670     RISPERDAL CONSTA  
Number of Participants Analyzed  
[units: participants]
 		  389     376  
Change in the Positive and Negative Syndrome Scale (PANSS) Total Score for Schizophrenia  
[units: Scores on a scale]
Mean ± Standard Deviation 		  -18.6  ± 15.45     -17.9  ± 14.24  


Statistical Analysis 1 for Change in the Positive and Negative Syndrome Scale (PANSS) Total Score for Schizophrenia
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
Mean Difference (Final Values) [3] 0.4
Standard Error of the mean ± 1.02
95% Confidence Interval ( -1.62 to 2.38 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Null hypothesis: Difference between groups (RISPERDAL CONSTA minus paliperidone palmitate) for the mean change from baseline to endpoint in PANSS total score (LOCF) was less than or equal to -5 (prespecified non-inferiority margin). Sample size: SD of 20 for the change in PANSS total score, a true difference between treatment groups of 0.1 in favor of RISPERDAL CONSTA, 2-sided significance level of 5%, and 80% power. A sample size reestimation was performed when 60% of the data was available.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  The non-inferiority margin was 5 points in the change in PANSS total score i.e., lower limit of the 95% CI for difference between groups (RISPERDAL CONSTA minus paliperidone palmitate) had to be greater than -5 to demonstrate non-inferiority.
[3] Other relevant estimation information:
  No text entered.



2.  Secondary:   The Change From Baseline for the CGI-S Score   [ Time Frame: Baseline to the last postrandomization assessment in the double-blind treatment period (approximately 13 weeks)] ]
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3.  Secondary:   The Change From Baseline in the PSP Score   [ Time Frame: Baseline to the last postrandomization assessment in the double-blind treatment period (approximately 13 weeks) ]
  Show Outcome Measure 3


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Of 1221 patients randomized, one patient was enrolled twice and assigned 2 patient numbers. Only the first patient number is included in the results reported for 1220 randomized patients.  


Results Point of Contact:  
Name/Title: Clinical Leader Psychiatry
Organization: Johnson & Johnson Pharmaceutical Research & Development LLC
phone: 1 609 730-2324


No publications provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Publications automatically indexed to this study:


Responsible Party: Clinical Leader Psychiatry, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00589914     History of Changes
Other Study ID Numbers: CR012289, R092670PSY3006
Study First Received: December 21, 2007
Results First Received: August 30, 2011
Last Updated: February 3, 2012
Health Authority: United States: Food and Drug Administration
Ukraine: State Pharmacological Center - Ministry of Health