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| Tracking Information | |||||
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| First Received Date ICMJE | May 11, 2007 | ||||
| Last Updated Date | October 2, 2009 | ||||
| Start Date ICMJE | April 2007 | ||||
| Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The primary endpoint is the mean modal prescribed daily dose of paliperidone from Day 1 to Day 84 inclusive of the study. [ Time Frame: Day 1 to Day 84 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
The primary endopoint is the mean modal prescribed daily dose of paliperidone from Day 1 to Day 84 inclusive of the study. | ||||
| Change History | Complete list of historical versions of study NCT00473434 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
To assess the clinical efficacy (CGI and GAF) of Paliperidone ER over the duration of the study.To evaluate the safety of Paliperidone ER over the duration of the study.To assess the long-term (2-year) treatment outcomes of Paliperidone ER. [ Time Frame: Over the duration of the study ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
To assess the clinical efficacy (CGI and GAF) of Paliperidone ER over the duration of the study.To evaluate the safety of Paliperiodone ER over the duration of the study.To assess the long-term (2-year) treatment oucomes of Paliperidone ER. | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | An Open Label Multicentre Study to Determine the Dose Distribution of Paliperidone ER in Patients With Schizophrenia | ||||
| Official Title ICMJE | An Open Label Multicentre Study to Determine the Dose Distribution of Paliperidone ER in Patients With Schizophrenia | ||||
| Brief Summary | The purpose of this trial is to evaluate the dose distribution, effectiveness and safety in patients with schizophrenia who are switched from an oral atypical antipsychotic to Paliperidone ER. In this study patients and physicians know the name and the dose of the study drug. Newly diagnosed patients will also be included in the study. In general, the recommended Paliperidone ER dose will be 6 mg once daily, however some patients may require a higher or lower initial dose in the recommended range of 3 to 12 mg once daily. The dose can be adjusted any point during the study, to a maximum dose of 12mg/day. Flexible dosing was chosen to best mimic actual clinical practice.The safety assessments to be conducted throughout this study including the regular monitoring and recording of all Adverse Events and Serious Adverse Events. |
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| Detailed Description | This trial is a non-randomised (both patient and physician know the study drug), single arm, open label multicentre study which is aimed to evaluate the dose distribution, efficacy and safety in patients with schizophrenia who are switched from an oral atypical antipsychotic to Paliperidone ER. Newly diagnosed patients will also be included in the study. In general, the recommended Paliperidone ER dose will be 6 mg once daily, however some patients may require a higher or lower initial dose in the recommended range of 3 to 12 mg once daily. The dose can be adjusted any point during the study, to a maximum dose of 12mg/day. Flexible dosing was chosen to best mimic actual clinical practice.The study duration will be split into two phases. Phase A will be 12 weeks and Phase B which will be an optional follow up phase will be 40 weeks. Assessment of efficacy and safety will be performed in Phase A at baseline, 2, 4, 6, 9 and 12 weeks and in Phase B at 20, 28, 36, 44 and 52 weeks. At the first visit, a full psychiatric history, demographic data and physical examination will be undertaken. Throughout the study, the following procedures, documentations and evaluations will be performed: descriptions of concomitant medications; hospitalisations for psychiatric reasons; clinical deterioration; Clinical Global Impression - Severity (CGI-S) and Global Assessment of Functioning (GAF) assessments; Community Treatment Order (CTO) status; weight; adherence and adverse event reporting. Physical examinations will be performed periodically. Paliperidone ER OROS will be supplied in 3 mg, 6 mg, and 9 mg tablets for oral administration. In general, the recommended Paliperidone ER dose will be 6 mg once daily, however some patients may require a higher or lower initial dose in the recommended range of 3 to 12 mg once daily. The dose can be adjusted any point during the study, to a maximum dose of 12mg/day. The study duration will be split into two phases. Phase A will be 12 weeks and Phase B which will be an optional follow up phase |
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| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Schizophrenia | ||||
| Intervention ICMJE | Drug: Paliperidone | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 64 | ||||
| Completion Date | August 2009 | ||||
| Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00473434 | ||||
| Responsible Party | Executive Director, Medical and Scientific Affairs, Janssen-Cilag Pty Ltd | ||||
| Study ID Numbers ICMJE | CR013213, R076477SCH3021 | ||||
| Study Sponsor ICMJE | Janssen-Cilag Pty Ltd | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Janssen-Cilag Pty Ltd | ||||
| Verification Date | October 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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