drugset / Trial / NCT01387542

Safety and Efficacy Study of Paliperidone Extended Release (ER) Among Thai Schizophrenia Participants

NCT01387542 ↗

Phase 4 Completed 40 enrolled Janssen-Cilag Ltd.,Thailand
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the effectiveness and safety of paliperidone extended release (ER) treatment in Thai schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) participants.

Timeline

Start
2009-08
Primary completion
2010-09
Completion
2010-09

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Paliperidone Extended Release (ER); p = 0.000; Friedman test NCT01387542 ↗

registry analysis (superiority or other test); Paliperidone Extended Release (ER); p = 0.009; Paired t-test NCT01387542 ↗

registry analysis (superiority or other test); Paliperidone Extended Release (ER); p = 0.001; Paired t-test NCT01387542 ↗

registry analysis (superiority or other test); Paliperidone Extended Release (ER); p = 0.000; Paired t-test NCT01387542 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Paliperidone extended release (ER) Unknown 3 mg Oral
Subject Paliperidone extended release (ER) Unknown 6 mg Oral
Subject Paliperidone extended release (ER) Unknown 9 mg Oral
Subject Paliperidone extended release (ER) Unknown 12 mg Oral

Indications