CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 133 enrolled
Drug / intervention
Paliperidone ERdrug
Likely dose
Paliperidone ER 12 milligramfrom 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/NCT01362439
NCT01362439Phase 4Completed
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Efficacy and Tolerability of Flexible Doses of Paliperidone ER in Symptomatic Subjects With Schizophrenia With Duration of Illness < 10 Years

Janssen-Cilag S.p.A.·interventional·Posted May 30, 2011·Updated Jun 5, 2013

In Brief

A Phase 4 clinical trial evaluating Paliperidone ER for Schizophrenia. Completed, enrolled 133 participants.

Detailed Summary

The purpose of this study is to evaluate the effectiveness and safety of paliperidone extended release (ER) in symptomatic participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) who were receiving treatment with any oral (having to do with the mouth) antipsychotic medication and who needed to be switched to paliperidone ER from the current oral antipsychotic therapy due to insufficient efficacy or due to side effects.

Study Details

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

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 30, 2011
Enrollment StartJan 1, 2009
Primary CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 15.1 years ago

Interventions

Paliperidone ERdrug

Participants will be administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose will be increased or decreased as per Investigator's discretion.