NCT00396565

A Study to Evaluate Effectiveness and Safety of ER OROS Paliperidone in Patients With Schizophrenia

A Placebo-Controlled Double Blind Comparative Study of JNS007ER in Patients With Schizophrenia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 394 (actual)
• Sponsor: Janssen Pharmaceutical K.K. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a multicenter, double blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), randomized (patients are assigned different treatments based on chance), placebo- and active-controlled, parallel-group study. Patients will be randomized into 1 of 3 treatment groups to receive oral dosages of Extended Release (ER) Osmotic Controlled-Release Oral Delivery System (OROS) paliperidone 6 mg, olanzapine 10 mg, or placebo. They will receive two capsules of Paliperidone ER 3 mg, placebo or Olanzapine 5 mg once daily after breakfast for 6 weeks. The study will include a screening period, followed by double-blind treatment for 6 weeks.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	ER OROS paliperidone	Type= exact number, unit= mg, number= 3, form= tablet, route= oral use. Two tablets once daily for 6 weeks.
DRUG	Placebo	Form= tablet, route= oral use. Two tablets once daily for 6 weeks.
DRUG	Olanzapine	Type= exact number, unit= mg, number= 2.5, form= tablet, route= oral use. Four tablets once daily for 6 weeks.

Timeline

• Start date: 2006-07-01
• Primary completion: 2007-11-01
• Completion: 2007-11-01
• First posted: 2006-11-07
• Last updated: 2014-04-29
• Results posted: 2012-07-03

Locations

56 sites across 1 country: Japan