NCT00791232

A Study of Extended Release Extended-release (ER) OROS Paliperidone Tolerability, as Compared to Immediate-release (IR)Risperidone, in Patients With Schizophrenia

A Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Phase 1 Study to Compare the Tolerability of OROS Paliperidone (Extended Release) With Immediate-release (IR) Risperidone in Subjects With Schizophrenia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 113 (actual)
• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is a noninferiority comparison of the orthostatic tolerability of a dose of 12 mg extended-release (ER) OROS paliperidone with the current recommended initial titration dose (2 mg) of immediate-release (IR) risperidone in patients with schizophrenia. Other study objectives are 1) to compare the tolerability and safety of a clinically equivalent fixed dose of ER OROS paliperidone with the currently recommended dose of risperidone, 2) to compare the early tolerability of the 2 treatments with placebo, 3) to compare tolerability of the 2 treatments, using a population pharmacokinetic/pharmacodynamic (pop PK/PD) model, to 4) assess the relationship between genetic variability in drug metabolizing enzymes and interindividual variability in plasma exposure to paliperidone or risperidone within each treatment group.

Detailed description

This is a randomized, double-blind, placebo- and active-controlled, parallel group, Phase 1. The study in patients with schizophrenia consists of a 1 week, open-label, placebo washout period (Days -7 to -1) and a 6 day double-blind treatment period during which patients will receive 1 of 3 treatments: placebo on Day 1 and ER OROS paliperidone (12 mg) on Days 2 to 6, ER OROS paliperidone (12 mg) on Days 1 to 6, or IR risperidone 2 mg on Day 1 and 4 mg on Days 2 to 6. Safety and tolerability will be monitored throughout the study.. ER OROS paliperidone (12 mg, oral) on Days 2 to 6, ER OROS paliperidone (12 mg, oral) on Days 1 to 6, or IR risperidone (oral) 2 mg on Day 1 and 4 mg on Days 2 to 6

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	extended-release (ER) OROS paliperidone

Timeline

• Start date: 2003-03-01
• Completion: 2003-06-01
• First posted: 2008-11-14
• Last updated: 2011-06-08