Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00101634
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2005-01-12
Brief Title:
Efficacy and Safety of a Long Acting Anti-Psychotic Versus Placebo in 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 Placebo-controlled Parallel-group Dose-response Study to Evaluate the Efficacy and Safety of 3 Fixed Doses 25 mg eq 50 mg eq and 100 mg eq of Paliperidone Palmitate in Patients With Schizophrenia
Status:
COMPLETED
Status Verified Date:
2011-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the efficacy how well the drug works safety and side effects of paliperidone palmitate compared to placebo in the treatment of the symptoms of schizophrenia in adults The placebo used in this study was a nutritional substance known as 20 Intralipid emulsion given to patients requiring intravenous feedings
Detailed Description:
Many patients with schizophrenia have difficulty adhering to a daily oral treatment regimen Long-acting injectable LAI formulations may provide therapeutic plasma concentrations over several weeks thereby eliminating the need for daily oral medication and making compliance easier This is a randomized patients will be assigned to different treatment groups based solely on chance double-blind neither the patient nor the physician will know if placebo or drug is being given and at what dose placebo-controlled parallel group multicenter dose-response study in adults who have schizophrenia The study consists of a screening period of no more than 7 days and a 13-week double-blind treatment period The screening period includes 4 days for tolerability testing if necessary In the double-blind treatment period patients will be randomly assigned to 1 of 4 treatment groups 3 fixed doses of paliperidone palmitate or placebo to receive 4 im injections of paliperidone palmitate or placebo on Days 1 8 36 and 64 The study including the screening period will last approximately 14 weeks Efficacy will be assessed throughout the study using the Positive and Negative Symptom Scale for Schizophrenia PANSS the Clinical Global Impression-Severity CGI-S and the Personal and Social Performance Scale PSP Safety will be evaluated throughout the study by monitoring adverse events extrapyramidal symptom EPS rating scales scores clinical laboratory test results vital signs and body weight measurements electrocardiograms ECGs and physical examination findings In addition the tolerability of injections will be assessed ER OROS paliperidone 3 mgday for 4 days Injections im of paliperidone palmitate 25 50 or 100 mg eq will be given on Days 1 8 36 and 64
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