Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00086320
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2004-06-30
Brief Title:
A Study of Effectiveness and Safety of Paliperidone Extended-release ER Tablets in the Prevention of Recurrence in 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-controlled Parallel-group Study With an Open-label Extension Evaluating Paliperidone Extended Release Tablets in the Prevention of Recurrence in Subjects 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 effectiveness and safety of paliperidone ER compared with placebo in the prevention of recurrence of symptoms of schizophrenia
Detailed Description:
Paliperidone ER is currently being investigated as treatment for the acute symptoms of schizophrenia and also as maintenance treatment This trial is designed to evaluate efficacy and safety of paliperidone ER in prevention of recurrence of psychotic symptoms in patients with schizophrenia This trial 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 parallel-group multicenter study consisting of 5 phases a screening phase of up to 5 days a 8-week open-label run-in phase during which all patients will be treated with open-label flexibly dosed paliperidone ER 3 to 15 mg orally once daily to identify a dose that will achieve control of their acute psychotic symptoms only patients who maintain a stable dosage regimen and have a total Positive and Negative Syndrome Scale PANSS score 70 Clinical Global Impression Scale - Severity CGI-S 4 and scores of 4 for PANSS items for delusions conceptual disorganization hallucinatory behavior suspiciousnesspersecution hostility and uncooperativeness during the last 2 weeks of the run-in phase will be eligible to continue in the stabilization phase a 6-week open-label stabilization phase patients who maintain control of their acute psychotic symptoms at the paliperidone ER dosage identified during the run-in phase and meet the total PANSS score CGI-S and PANSS items scores throughout the stabilization phase will be randomized to receive either flexibly dosed paliperidone ER starting at the dose maintained during the stabilization phase of the study or placebo a double-blind treatment phase of variable duration during which patients will be followed until they meet either defined criteria for recurrence or the study ends a 52-week open-label extension phase for patients who experience a recurrence event during the double-blind phase of the study or who remain recurrence free for the entire double-blind phase of the study Efficacy will be assessed using the PANSS and CGI-S scores that will be collected every week every 2 weeks or every 4 weeks throughout Safety assessments include the incidence of adverse events throughout the study measurement of vital signs orthostatic pulse rate orthostatic blood pressure and temperature and clinical laboratory tests In the run-in double-blind and open-label extension phases of the study paliperidone ER or matching placebo will be flexibly dosed in the range 3 to 15 mg orally once a day 3 6 9 12 or 15 mgday The dosage in the stabilization phase will be fixed throughout at the dosage that achieved symptom control in the run-in phase
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