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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01362426




Registration number
NCT01362426
Ethics application status
Date submitted
26/05/2011
Date registered
30/05/2011
Date last updated
10/03/2016

Titles & IDs
Public title
Paliperidone Palmitate Effectiveness Assessment Registry - Longitudinal (PEARL)
Scientific title
A Quality Use of Medicine Clinical Registry to Assess Clinical Outcomes in Patients With Schizophrenia Treated With Intramuscular Injections of Paliperidone Palmitate
Secondary ID [1] 0 0
CR018013
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Schizophrenia

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - paliperidone palmitate

001 - paliperidone palmitate Dosage and administration will be according to the paliperidone palmitate approved Australian Product Information.


Treatment: Drugs: paliperidone palmitate
Dosage and administration will be according to the paliperidone palmitate approved Australian Product Information.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of patients with symptomatic relapse
Timepoint [1] 0 0
Up to 12 months
Secondary outcome [1] 0 0
Clinical effectiveness and social outcomes as measured by the following clinical assessment tools: CGI-S.
Timepoint [1] 0 0
Up to 12 months
Secondary outcome [2] 0 0
Clinical effectiveness and social outcomes as measured by HoNOS.
Timepoint [2] 0 0
Up to 12 months
Secondary outcome [3] 0 0
Clinical effectiveness and social outcomes as measured by PSP.
Timepoint [3] 0 0
Up to 12 months
Secondary outcome [4] 0 0
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Timepoint [4] 0 0
Up to 12 months
Secondary outcome [5] 0 0
Clinical effectiveness and social outcomes as measured by the following clinical assessment tools: GAF
Timepoint [5] 0 0
Up to 12 months

Eligibility
Key inclusion criteria
* Must fulfill the diagnostic criteria for Schizophrenia Disorders as defined by Diagnostic and Statistical Manual of Mental Disorders Version IV (DSM-IV)
* Must meet the approved Therapeutic Goods Administration (TGA) indication for injectable paliperidone palmitate
* Must have provided written informed consent indicating that they understand the purpose of and procedures required for the registry and are willing to participate in the registry.
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Those with a known hypersensitivity to either paliperidone or risperidone, or to any excipients in the paliperidone palmitate formulation
* Employees of the clinician or study centre, with direct involvement in the proposed registry or other studies under the direction of that clinician or study centre, as well as family members of the employees or the clinician.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2013
Sample size
Target
Accrual to date
Final
127
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Bendigo
Recruitment hospital [2] 0 0
- Box Hill
Recruitment hospital [3] 0 0
- Elizabeth Vale
Recruitment hospital [4] 0 0
- Epping
Recruitment hospital [5] 0 0
- Fitzroy
Recruitment hospital [6] 0 0
- Fremantle
Recruitment hospital [7] 0 0
- Glenside
Recruitment hospital [8] 0 0
- Meadowbrook
Recruitment hospital [9] 0 0
- Waratah
Recruitment hospital [10] 0 0
- Wollongong
Recruitment postcode(s) [1] 0 0
- Bendigo
Recruitment postcode(s) [2] 0 0
- Box Hill
Recruitment postcode(s) [3] 0 0
- Elizabeth Vale
Recruitment postcode(s) [4] 0 0
- Epping
Recruitment postcode(s) [5] 0 0
- Fitzroy
Recruitment postcode(s) [6] 0 0
- Fremantle
Recruitment postcode(s) [7] 0 0
- Glenside
Recruitment postcode(s) [8] 0 0
- Meadowbrook
Recruitment postcode(s) [9] 0 0
- Waratah
Recruitment postcode(s) [10] 0 0
- Wollongong

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen-Cilag Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01362426
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen-Cilag Pty Ltd Clinical Trial
Address 0 0
Janssen-Cilag Pty Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01362426