drugset / Trial / NCT00604279

A Comparative Study of Paliperidone Palmitate and Risperidone Long Acting Injection (LAI) in Participants With Schizophrenia

NCT00604279

Phase 3 Completed 452 enrolled Xian-Janssen Pharmaceutical Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to compare the efficacy of paliperidone palmitate and risperidone long acting injection (LAI) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) along with safety and tolerability.

Timeline

Start
2008-01
Primary completion
2009-01
Completion
2009-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Risperidone Other / unclassified 1 mg Intramuscular
Comparator Risperidone Other / unclassified 2 mg Intramuscular
Comparator Risperidone Other / unclassified 6 mg Intramuscular
Comparator Risperidone Other / unclassified 25 mg Intramuscular
Comparator Risperidone Other / unclassified 37.5 mg Intramuscular
Comparator Risperidone Other / unclassified 50 mg Intramuscular
Subject paliperidone palmitate Unknown 50 mg Intramuscular
Subject paliperidone palmitate Unknown 100 mg Intramuscular
Subject paliperidone palmitate Unknown 150 mg Intramuscular

Indications