Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00077714
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2004-02-11
Brief Title:
Trial Evaluating the Efficacy and Safety of 2 Fixed Doses of Paliperidone Extended-Release ER Tablets in the Treatment of Adult 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 2 Fixed Dosages of Paliperidone Extended Release Tablets and Olanzapine With Open-label Extension in the Treatment of 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 trial is to determine if paliperidone ER is an effective treatment for adults 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 safety and tolerability of 2 fixed dosages of paliperidone ER compared with placebo in adult patients with schizophrenia This is a multicenter double-blind neither the patient nor the physician will know if placebo or drug is being given and at what dose randomized patients will be assigned to different treatment groups based solely on chance placebo- and active-controlled parallel-group dose-response study Patients will be randomized into 1 of 4 treatment groups to receive oral dosages of paliperidone ER 6 mg or 12 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 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 a 52-week open-label extension phase 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 Schizophrenia Quality of Life Scale Revision 4 SQLS-R4 and Sleep Visual Analog Scale VAS The efficacy response will be measured by the change from baseline score to end of double-blind phase for PANSS PSP CGI-S SQLS-R4 and Sleep VAS 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 6 mg or 12 mg fixed dose of paliperidone ER olanzapine 10 mg or matching placebo taken orally once daily for 6 weeks
Open-label extension start on paliperidone ER 9 mg taken orally once daily maintained on a flexible dosage of paliperidone ER 3 6 9 or 12 mgday for 52 weeks
Open-label extension start on paliperidone ER 9 mg taken orally once daily maintained on a flexible dosage of paliperidone ER 3 6 9 or 12 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