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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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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) ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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