Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00078039
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2004-02-17
Brief Title:
Trial Evaluating Three Fixed Dosages 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:
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 6 9 and 12 mgDay and Olanzapine 10 mgDay With Open-label Extension in Treatment of 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 primary objective of the double blind phase of this study is to evaluate the efficacy and safety of 3 fixed dosages of paliperidone ER 6 9 and 12 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 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 of 3 fixed dosages of paliperidone ER 6 9 and 12 mgday compared with placebo in patients with schizophrenia This trial 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 The study includes a screening period of up to 5 days followed by double-blind treatment phase of 6 weeks 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 Patients will be randomly assigned to 1 of 5 treatments paliperidone ER 6 9 or 12 mg olanzapine 10 mg or placebo and will take oral dosages of assigned treatment once daily during the 6-week double-blind period At the time patients enter the double-blind period they must be inpatients and must remain in the hospital for a minimum of 14 full days While patients are hospitalized efficacy will be assessed twice during the first week and at the end of the second week 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 period The efficacy response will be measured by the change in the PANSS total score from start of treatment to the end of the double-blind phase 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 lying down and standing blood pressure pulse temperature electrocardiograms and clinical laboratory tests Double-blind 6- 9- or 12-mg fixed dose of paliperidone ER olanzapine 10 mg or placebo taken orally once daily for 6 weeks
Open-label extension start on paliperidone ER 9 mg taken orally once a day maintained on a flexible oral 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 a day maintained on a flexible oral 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