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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00094640
Registration number
NCT00094640
Ethics application status
Date submitted
21/10/2004
Date registered
22/10/2004
Date last updated
19/07/2006
Titles & IDs
Public title
Pharmacokinetic Characterization of Intramuscular Olanzapine Depot
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Scientific title
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Secondary ID [1]
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F1D-EW-LOBS
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Secondary ID [2]
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6106
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Schizophrenia
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Schizoaffective Disorder
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Condition category
Condition code
Mental Health
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Schizophrenia
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Mental Health
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Psychosis and personality disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Intramuscular Olanzapine Depot
Treatment: Drugs: Intramuscular Olanzapine Depot
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Eligibility
Key inclusion criteria
- Patients must have schizophrenia or schizoaffective disorders.
- Each patient must have a level of understanding sufficient to complete all tests and
examinations required by the protocol, and to provide informed consent.
- Patient must not have participated in a clinical trial of another investigational
drug, including olanzapine, within 1 month (30 days) prior to study entry.
- Female patients must not be pregnant or breast-feeding.
- Patients must not be experiencing acute, serious, or unstable medical conditions other
than schizophrenia or schizoaffective disorder.
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Minimum age
18
Years
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Maximum age
76
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. - Adelaide
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Recruitment postcode(s) [1]
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- Adelaide
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Recruitment outside Australia
Country [1]
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Belgium
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State/province [1]
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Kortenberg
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Country [2]
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Brazil
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State/province [2]
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RJ
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Country [3]
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Croatia
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State/province [3]
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Zagreb
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Country [4]
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Czech Republic
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State/province [4]
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Praha 8
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Country [5]
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Mexico
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State/province [5]
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Tlalpan
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Country [6]
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Slovakia
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State/province [6]
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Bratislava
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Country [7]
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Spain
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State/province [7]
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Barcelona
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Eli Lilly and Company
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The goals of this study are to:
Determine the blood levels of intramuscular (IM) olanzapine depot in patients at different
points in time after an injection, and compare these levels to the amount of olanzapine in
the blood of patients after treated by oral administration with Zyprexa (olanzapine) tablets
or by intramuscular administration with Zyprexa IntraMuscular (olanzapine for injection).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00094640
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00094640
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