Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00111189
Status:
COMPLETED
Last Update Posted:
2014-06-20
First Post:
2005-05-17
Brief Title:
A Study of the Efficacy Effectiveness of Paliperidone Palmitate in the Prevention of Recurrence of the Symptoms of 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 Evaluating Paliperidone Palmitate in the Prevention of Recurrence in Patients With Schizophrenia Placebo Consists of 20 Intralipid 200 mgmL Injectable Emulsion
Status:
COMPLETED
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the efficacy of paliperidone palmitate compared with placebo in the prevention of recurrence of the symptoms of schizophrenia and to assess the safety and tolerability of paliperidone palmitate in patients with stable and symptomatic schizophrenia The placebo used in this study was a nutritional substance known as 20 Intralipid emulsion given to patients requiring intravenous feedings
Detailed Description:
Many patients with schizophrenia have difficulty adhering to a daily oral treatment regimen Long-acting injectable formulations such as long-acting injectable paliperidone palmitate may provide therapeutic plasma concentrations over several weeks thereby eliminating the need for daily oral medication and making compliance easier This study 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 followed by an open-label extension period in patients with schizophrenia The study is designed to evaluate the efficacy of paliperidone palmitate a long-acting injectable formulation in delaying the time to and decreasing the rate of recurrence compared with placebo in patients with schizophrenia The study will consist of 5 periods an up to 7-day screeningwashouttolerability period a 9-week open-label transition period a 24-week open-label maintenance period a randomized variable-length double-blind placebo-controlled recurrence prevention period and an up to 52-week open-label extension period Patients will have intramuscular im study drug injections and efficacy and safety evaluations performed every 4 weeks throughout the study Efficacy will be evaluated during the study using a recurrence assessment the Positive and Negative Symptom Scale for Schizophrenia PANSS the Clinical Global Impression - Severity CGI-S scale and the Personal and Social Performance PSP scale Safety will be assessed throughout the study by monitoring adverse events use of extrapyramidal symptoms EPS rating scales Abnormal Involuntary Movement Scale AIMS Barnes Akathisia Rating Scale BARS Simpson Angus Scale SAS clinical laboratory testing vital signs temperature blood pressure and heart rate measurements electrocardiograms ECGs and physical examinations Additionally the patients will assess the tolerability of the injections by evaluating the pain of the injection and the pain at the injection sites Tolerability test 3 mgday of oral ER OROS paliperidone for 4 days Transition 9 wks 50 mg eq paliperidone palmitate im dose on Day 1 then im injections 25 50 or 100 mg eq once every 4 wks q4wk Maintenance 24-wks paliperidone palmitate im injections 25 50 or 100 mg eq q4wk Recurrence Prevention paliperidone palmitate im injections 25 50 or 100 mg eq or placebo q4wk Open-label paliperidone palmitate 25 50 75 or 100 mg eq q4wk for 12 dosing periods
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R092670PSY3001 | None | None | None |