Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00083668
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2004-05-27
Brief Title:
Trial Evaluating Three Fixed Doses of Paliperidone Extended-Release ER Tablets and Olanzapine in the Treatment of 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- and Active-controlled Parallel-group Dose-response Study to Evaluate the Efficacy and Safety of 3 Fixed Dosages of Paliperidone Extended Release ER Tablets and Olanzapine With Open-label Extension in the Treatment of Patients With Schizophrenia
Status:
COMPLETED
Status Verified Date:
2010-03
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 primary objective of the double-blind phase of this study is to evaluate the efficacy and safety of 3 fixed dosages of paliperidone ER 3 9 and 15 mgday compared with placebo in adult patients with schizophrenia
Detailed Description:
Paliperidone is being developed as a new therapeutic agent for the treatment of schizophrenia The extended-release ER formulation of paliperidone was developed to deliver paliperidone at a relatively constant rate over a 24-hour period to improve the tolerability profile and decrease the potential for orthostatic hypotension This study is designed to evaluate the efficacy and safety and tolerability of 3 dosages of paliperidone ER compared with placebo in adult patients with schizophrenia This is a multicenter double-blind randomized placebo- and active-controlled parallel-group dose-response study Patients will be randomized into 1 of 5 treatment groups to receive oral dosages of paliperidone ER 3 9 or 15 mg olanzapine 10 mg or placebo once daily for a 6-week period The study includes a screening period of up to 5 days followed by a 6-week double-blind treatment phase Following the double-blind treatment phase eligible patients those who have completed the 6-week double-blind phase or who discontinue due to lack of efficacy after a minimum of 21 days may enter the 52-week open-label extension with paliperidone ER monotherapy While patients are hospitalized efficacy will be assessed twice during the first week and at the end of the second week and after patients are discharged from the hospital they will return to have efficacy and safety assessments performed on a weekly basis through the end of the 6-week double-blind phase Efficacy will be evaluated throughout the 6-week double-blind phase by completion of the Positive and Negative Syndrome Scale PANSS Clinical Global Impression Scale - Severity CGI-S Personal and Social Performance Scale PSP and Schizophrenia Quality of Life Scale Revision 4 SQLS-R4 The primary efficacy response will be measured by the change from baseline score to end of double-blind phase for PANSS total score Safety will be monitored throughout the study and includes assessments of the incidence of adverse events measurement of extrapyramidal symptoms using 3 rating scales Abnormal Involuntary Movement Scale AIMS Barnes Akathisia Rating Scale BARS Simpson-Angus Rating Scale SAS measurement of vital signs laying down and standing blood pressure pulse temperature electrocardiograms and clinical laboratory tests Double-blind phase 3 9 15 mg of paliperidone ER 10 mg of olanzapine or placebo taken orally once a day for 6 weeks
Open-label phase start on paliperidone ER 9 mg orally once a day maintained on a flexible oral dosage of paliperidone ER 3 6 9 12 or 15 mgday for 52 weeks
Open-label phase start on paliperidone ER 9 mg orally once a day maintained on a flexible oral dosage of paliperidone ER 3 6 9 12 or 15 mgday for 52 weeks
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