CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 223 enrolled
Drug / intervention
Paliperidone Extended Release (ER)drug
Likely dose
Paliperidone Extended Release (ER) 12 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01010776
NCT01010776Phase 4Completed
CompareCT.gov

A Study to Evaluate Switching From Risperidone to Paliperidone ER (Extended Release) in the Treatment of Stable But Symptomatic Schizophrenia Outpatients: Patients Satisfaction and Quality of Life

Janssen-Cilag Farmaceutica Ltda.·interventional·Posted Nov 10, 2009·Updated Nov 20, 2013

In Brief

A Phase 4 clinical trial evaluating Paliperidone Extended Release (ER) for Schizophrenia. Completed, enrolled 223 participants across 10 sites.

Detailed Summary

The purpose of this study is to evaluate effectiveness, tolerability (how well a participant can stand a particular medicine or treatment), and safety of flexible-dose of paliperidone extended release (ER) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self), previously taking risperidone (an antipsychotic), but who are not satisfied with their treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesBrazil
Collaborators--

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 10, 2009
Enrollment StartFeb 1, 2008
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 16.6 years ago

Interventions

Paliperidone Extended Release (ER)drug

Paliperidone ER tablets in the flexible dose ranging from 3 to 12 mg will be administered orally once daily for 26 weeks of Main Phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator's discretion.