Paliperidone Palmitate Effectiveness Assessment Registry - Longitudinal (PEARL)
| Tracking Information | |||||
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| First Received Date ICMJE | May 26, 2011 | ||||
| Last Updated Date | April 9, 2013 | ||||
| Start Date ICMJE | March 2011 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Number of patients with symptomatic relapse [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01362426 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Paliperidone Palmitate Effectiveness Assessment Registry - Longitudinal (PEARL) | ||||
| Official Title ICMJE | A Quality Use of Medicine Clinical Registry to Assess Clinical Outcomes in Patients With Schizophrenia Treated With Intramuscular Injections of Paliperidone Palmitate | ||||
| Brief Summary | The primary objective of this study is to determine if Australian patients with schizophrenia treated with paliperidone palmitate under conditions of continuous monitoring of outcomes over a 12-month period achieve relapse rates comparable to published literature. |
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| Detailed Description | This study involves the establishment of PEARL, an Australian Quality Use of Medicine clinical registry designed to collect clinical and social data on up to 300 patients with schizophrenia for a 12-month period after initiating treatment with intramuscular (IM) injections of paliperidone palmitate as part of their routine clinical care. Continuous feedback of clinical outcomes will be via regular reports to all registry sites. Enrollment in PEARL should be considered only after the clinical decision to prescribe IM paliperidone palmitate has already been made because the treating physician has determined that this treatment is the best option for the patient. Observational Study - No investigational drug administered |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Australian patients with schizophrenia will be enrolled in the registry |
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| Condition ICMJE | Schizophrenia | ||||
| Intervention ICMJE | Drug: paliperidone palmitate
Dosage and administration will be according to the paliperidone palmitate approved Australian Product Information. |
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| Study Group/Cohort (s) | 001
paliperidone palmitate Dosage and administration will be according to the paliperidone palmitate approved Australian Product Information.
Intervention: Drug: paliperidone palmitate |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 128 | ||||
| Estimated Completion Date | May 2013 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Australia | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01362426 | ||||
| Other Study ID Numbers ICMJE | CR018013 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Janssen-Cilag Pty Ltd | ||||
| Study Sponsor ICMJE | Janssen-Cilag Pty Ltd | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Janssen-Cilag Pty Ltd | ||||
| Verification Date | April 2013 | ||||
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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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