A Study of Paliperidone Palmitate in Japanese Patients With Schizophrenia
|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|
|Primary Completion Date :||November 2012|
|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) ]
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.|