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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | June 11, 2007 | ||||
| Last Updated Date | June 11, 2007 | ||||
| Start Date ICMJE | July 2004 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Assess the efficacy of IM olanzapine compared with IM haloperidol in changing of agitation from baseline to 2 hours post-first IM injection | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Comparison of Intramuscular Olanzapine and Intramuscular Haloperidol in Patients With Schizophrenia | ||||
| Official Title ICMJE | A Double-Blind Randomized Comparison of the Efficacy and Safety of Intramuscular Olanzapine and Intramuscular Haloperidol in Acutely Agitated Patients With Schizophrenia | ||||
| Brief Summary | The purpose of this study is to compare intramuscular Olanzapine and intramuscular Haloperidol in changing of agitation in patients with schizophrenia |
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| Detailed Description | |||||
| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Schizophrenia | ||||
| Intervention ICMJE |
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| 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 | 50 | ||||
| Completion Date | January 2005 | ||||
| Primary Completion Date | |||||
| 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 | Taiwan | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00485901 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 6409, F1D-TW-S025 | ||||
| Study Sponsor ICMJE | Eli Lilly and Company | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Eli Lilly and Company | ||||
| Verification Date | June 2007 | ||||
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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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