Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00210717
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2005-09-13
Brief Title:
A Study to Compare the Effectiveness and Safety of Flexibly Varied Doses of Paliperidone Palmitate and Risperidone in Treating Patients With Schizophrenia
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Randomized Double-Blind Parallel Group Comparative Study of Flexibly Dosed Paliperidone Palmitate 25 50 75 or 100 mg eq Administered Every 4 Weeks and Flexibly Dosed RISPERDAL CONSTA 25 375 or 50 mg Administered Every 2 Weeks in Subjects With Schizophrenia
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare the effectiveness and safety over 1 year of treatment of intramuscular injections of paliperidone palmitate and long-acting risperidone in patients with schizophrenia
Detailed Description:
Paliperidone palmitate is being developed as a long-acting intramuscular injectable formulation for the treatment of schizophrenia Many patients with schizophrenia achieve symptom stability with the available oral antipsychotic medications however it is estimated that up to 75 have difficulty adhering to a daily oral treatment regimen Long-acting injectable formulations may make compliance with the treatment regimen easier by eliminating the need for daily medication An injectable formulation of risperidone is widely used in the treatment of schizophrenia and has been well tolerated by patients with chronic schizophrenia at the recommended dosage of 25 to 50 milligrams every 2 weeks The present study is designed to evaluate the comparability of paliperidone palmitate and long-acting injectable risperidone over 1 year of treatment
This is a randomized double-blind active-controlled parallel-group multicenter comparative study in patients with schizophrenia The study comprises a screening period of up to 1 week including periods for washout of psychotropic medications and if necessary an oral tolerability test and a 53-week double-blind treatment period In the double-blind treatment period patients will be randomly assigned in equal numbers to receive treatment with either 1 flexibly dosed paliperidone palmitate administered every 4 weeks or 2 flexibly dosed long-acting risperidone administered every 2 weeks Drug effectiveness and safety will be evaluated periodically throughout the study Samples for pharmacokinetic evaluation will be collected at designated time points and a blood sample will be collected at baseline before the start of the double-blind treatment period or at any subsequent visit for an optional pharmacogenomic genetic analysis The study hypothesis is that paliperidone palmitate will be as effective as long-acting risperidone in the treatment of patients with schizophrenia Paliperidone palmitate 25 50 75 or 100 milligrams mg equivalent every 4 weeks or long-acting risperidone 25 375 or 50 mg every 2 weeks of double-blind treatment period injected into the gluteal muscle buttocks Oral risperidone 1-6 mg first 4 weeks of double-blind period
This is a randomized double-blind active-controlled parallel-group multicenter comparative study in patients with schizophrenia The study comprises a screening period of up to 1 week including periods for washout of psychotropic medications and if necessary an oral tolerability test and a 53-week double-blind treatment period In the double-blind treatment period patients will be randomly assigned in equal numbers to receive treatment with either 1 flexibly dosed paliperidone palmitate administered every 4 weeks or 2 flexibly dosed long-acting risperidone administered every 2 weeks Drug effectiveness and safety will be evaluated periodically throughout the study Samples for pharmacokinetic evaluation will be collected at designated time points and a blood sample will be collected at baseline before the start of the double-blind treatment period or at any subsequent visit for an optional pharmacogenomic genetic analysis The study hypothesis is that paliperidone palmitate will be as effective as long-acting risperidone in the treatment of patients with schizophrenia Paliperidone palmitate 25 50 75 or 100 milligrams mg equivalent every 4 weeks or long-acting risperidone 25 375 or 50 mg every 2 weeks of double-blind treatment period injected into the gluteal muscle buttocks Oral risperidone 1-6 mg first 4 weeks of double-blind period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None