Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00460512
Status:
COMPLETED
Last Update Posted:
2021-03-26
First Post:
2007-04-13
Brief Title:
An Efficacy Safety And Tolerability Study of Flexibly Dosed Paliperidone Extended Release ER in Participants With Schizophrenia
Sponsor:
Janssen-Cilag International NV
Organization:
Janssen-Cilag International NV
Study Overview
Official Title:
An Open-label Prospective Trial to Explore the Tolerability Safety and Efficacy of Flexibly Dosed Paliperidone ER in Subjects With Schizophrenia
Status:
COMPLETED
Status Verified Date:
2021-03
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:
PERFlexS
Brief Summary:
The purpose of this study is to explore tolerability safety and effectiveness of flexibly dosed paliperidone extended release ER in participants with schizophrenia psychiatric disorder with symptoms of emotional instability detachment from reality often with delusions and hallucinations and withdrawal into the self previously unsuccessfully treated with an oral antipsychotic medication
Detailed Description:
This is a non-randomized the study drug is not assigned by chance single arm multicenter when more than one hospital or medical school team work on a medical research study 6-month study Participants can be transitioned to an effective dose of paliperidone ER from any oral antipsychotic medication due to lack of efficacy lack of tolerability or safety lack of compliance or other reason A transition period of maximum 4 weeks will be allowed Throughout the study participants will receive flexible dose of 3 to 12 milligram mg of paliperidone once daily orally for 6 months Adjustment of the dosage will be done at Investigators discretion based on the individual participants clinical response and tolerability of the study drug dosages Participants who complete this 6-month study and would like to continue will be eligible to be enrolled in an extension phase until paliperidone ER is available The starting dose of the extension phase will be the same as at the end of the 6-month study and may be changed throughout the extension period The extension phase will consist of a main extension phase ending with an End of Main Extension Phase Visit and a modified extension phase ending with an End of Study Visit Efficacy will primarily be evaluated by positive and negative syndrome scale PANSS Safety will primarily be evaluated by Extrapyramidal Symptom Rating Scale ESRS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| R076477SCH3017 | OTHER | None | None |
| 2006-004265-34 | EUDRACT_NUMBER | Janssen-Cilag International NV | None |