A Study of Paliperidone Palmitate in Japanese Patients With Schizophrenia
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|ClinicalTrials.gov Identifier: NCT01258920|
Recruitment Status : Completed
First Posted : December 13, 2010
Last Update Posted : June 24, 2014
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: Paliperidone palmitate||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||201 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Long-Term, Open-Label Study of Flexibly Dosed Paliperidone Palmitate Long-Acting Intramuscular Injection in Japanese Patients With Schizophrenia|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||November 2012|
Experimental: Paliperidone palmitate
Paliperidone palmitate Paliperidone palmitate will be administered im as an initial loading dose of 150 mg eq. on Day 1 and 100 mg eq. 1 week later in the deltoid muscle and will be administered in a flexible dose range of 25 to 150 mg eq. at 4-week intervals from Week 5 for a total of 11 injections.
Drug: Paliperidone palmitate
Paliperidone palmitate will be administered im as an initial loading dose of 150 mg eq. on Day 1 and 100 mg eq. 1 week later in the deltoid muscle, and will be administered in a flexible dose range of 25 to 150 mg eq. at 4-week intervals from Week 5 for a total of 11 injections.
- Incidence of adverse events as a measure of safety and tolerability [ Time Frame: 49 Weeks ]
- The change from baseline in Positive and Negative Syndrome Scale (PANSS) total score [ Time Frame: Baseline, Week 49 ]The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.
- The change from baseline in Clinical Global Impression - Severity (CGI-S) score [ Time Frame: Baseline, Week 49 ]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". Higher scores indicate worsening.
- Pharmacokinetic evaluations (graphically display to explore dose proportionality and achievement of steady state) [ Time Frame: 49 Weeks (Baseline, Week 1, 5, 9, 13, 21, 25, 37, 45, 47 and 49) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01258920
|Study Director:||Janssen Pharmaceutical K.K. Clinical Trial||Janssen Pharmaceutical K.K.|