CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 394 enrolled
Drug / intervention
ER OROS paliperidone +2 moredrug
Likely dose
Not stated in 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/NCT00396565
NCT00396565Phase 3Completed
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A Placebo-Controlled Double Blind Comparative Study of JNS007ER in Patients With Schizophrenia

Janssen Pharmaceutical K.K.·interventional·Posted Nov 7, 2006·Updated Apr 29, 2014

In Brief

A Phase 3 clinical trial evaluating ER OROS paliperidone, Placebo, and 1 other intervention for Schizophrenia. Completed, enrolled 394 participants across 56 sites.

Detailed Summary

The purpose of this study is to evaluate the effectiveness and safety of Extended Release Osmotic Controlled-Release Oral Delivery System (OROS) Paliperidone compared to placebo in patients with Schizophrenia. Olanzapine will be used as a reference drug in the study.

Study Details

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

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 7, 2006
Enrollment StartJul 1, 2006
Primary CompletionNov 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 19.7 years ago

Interventions

ER OROS paliperidonedrug

Type= exact number, unit= mg, number= 3, form= tablet, route= oral use. Two tablets once daily for 6 weeks.

Placebodrug

Form= tablet, route= oral use. Two tablets once daily for 6 weeks.

Olanzapinedrug

Type= exact number, unit= mg, number= 2.5, form= tablet, route= oral use. Four tablets once daily for 6 weeks.