Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00074477
Status:
COMPLETED
Last Update Posted:
2011-05-24
First Post:
2003-12-12
Brief Title:
Safety and Efficacy of an Anti-Psychotic 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 Study to Evaluate the Efficacy and Safety of 50 and 100 Mg-eq of Paliperidone Palmitate in Patients With Schizophrenia
Status:
COMPLETED
Status Verified Date:
2010-04
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 injection 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:
Paliperidone palmitate is an aqueous suspension that releases paliperidone gradually over a period of about 1 month and is under development to provide a sustained and stable level of paliperidone 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 multicenter study in patients with schizophrenia The study consists of a screening period maximum 5 days including a 3-day washout of psychotropic medications other than antidepressants if applicable a 7-day open-label oral run-in period and a 64-day double-blind treatment period The total duration of the study is approximately 11 weeks Efficacy will be evaluated during the study using the Positive and Negative Symptom Scale for Schizophrenia PANSS and the Clinical Global Impression - Severity CGI-S scale Safety will be evaluated by monitoring adverse events and changes in clinical laboratory results including prolactin levels physical examination results tardive dyskinesia will be rated using the Abnormal Involuntary Movement Scale AIMS akathisia will be rated according to the Barnes Akathisia Rating Scale BARS extrapyramidal symptoms will be evaluated using the Simpson-Angus Rating Scale SAS electrocardiogram ECG vital sign measurements and concomitant therapy ER OROS paliperidone 6 or 12 mg or IR paliperidone 2 or 4 mg oral dosage administered daily for 7 days Day -7 to -1 followed by im injections of paliperidone palmitate either 50 mg eq or 100 mg eq or placebo on Days 1 8 and 36 of the study
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