Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00085748
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2004-06-14
Brief Title:
Safety Study With Paliperidone ER Extended-Release ER Tablets in Geriatric Patients With Schizophrenia
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Randomized 6-Week Double-Blind Placebo-Controlled Study With an Optional 24-Week Open-Label Extension to Evaluate the Safety and Tolerability of Flexible Doses of Paliperidone Extended Release in the Treatment of Geriatric Patients With Schizophrenia
Status:
COMPLETED
Status Verified Date:
2010-11
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 study is to evaluate the safety and tolerability of flexible dosages of paliperidone ER as compared with placebo in patients with schizophrenia who are 65 years of age or older The primary objective of the open-label extension is the long-term assessment of safety and tolerability of paliperidone ER in patients diagnosed 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 Typically elderly persons with schizophrenia respond well to antipsychotic drugs However medications should be administered cautiously and usually at lower starting dosages than those prescribed for younger patients with care taken to balance efficacy and tolerability Flexible dosages of paliperidone ER have been chosen for this study to better achieve this balance and more closely mimic clinical practice 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-controlled parallel-arm study The primary purpose of the study is to evaluate the safety and tolerability of flexible doses of paliperidone ER in patients with schizophrenia who are 65 years of age or older The study consists of a screening phase of up to 5 days a 6-week double-blind treatment phase and an optional 24-week open-label treatment phase For administrative purposes the screening and the double-blind treatment phases are referred to as R076477-SCH-302 and the open-label treatment phase is named R076477-SCH-702 Patients will be randomly assigned to receive paliperidone ER or placebo At the time patients enter the double-blind period they must be hospitalized for a minimum of 14 full days Those patients who receive paliperidone ER will start at a dosage of 6 mg taken daily which may be titrated up to a maximum of 12 mg or down to a minimum of 3 mg daily based on the patients safety and tolerability of the drug Patients who complete the 6 weeks of double-blind treatment or who finish at least 21 days of treatment and discontinue because of lack of efficacy may enter the 24-week open label treatment phase While patients are hospitalized efficacy will be assessed twice during the first week and at the end of the second week 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 during the double-blind treatment phase The efficacy variable will be measured by the change from baseline score for PANSS CGI S SQLS-R4 Sleep VAS and PSP Safety will be monitored throughout the study based on 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 blood pressure heart rate electrocardiograms and clinical laboratory tests Double-blind phase paliperidone ER will be flexibly dosed in the range 3 to 12 mg 3 6 9 or 12 mgday orally once a day or matching placebo for 6 weeks
Open-label phase The starting dose is 6 mgday for 7 days thereafter flexible oral dosage of paliperidone ER 3 6 9 or 12 mgday for 24 weeks
Open-label phase The starting dose is 6 mgday for 7 days thereafter flexible oral dosage of paliperidone ER 3 6 9 or 12 mgday for 24 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