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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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23 March 2015 |
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Main ID: |
NCT00290082 |
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Date of registration:
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09/02/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Randomized Double-blind Trial of Midazolam and Loxapine in Agitated Patients
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Scientific title:
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Comparison Between Midazolam and Loxapine in the Treatment of Agitated Patients in the Emergency Department |
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Date of first enrolment:
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December 2005 |
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Target sample size:
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120 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00290082 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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France
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Contacts
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Name:
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Fabienne FM Moritz, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Rouen |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Severely agitated patients (Richard Scale over or equal to 5) between 18 and 65 years old
Exclusion Criteria:
Hypoglycemia hypoxemia patients with known dementia blood pressure <90 mmHg known cocaine
or amphetamine intoxication pregnancy respiratory or liver insufficiency myasthenia
sedation before arrival to hospital
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Acute Agitated Patients
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Intervention(s)
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Drug: Midazolam
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Other: patient monitoring
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Drug: Loxapine
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Drug: loxapine, midazolam
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Biological: blood sample
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Primary Outcome(s)
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Success of treatment at 20 min
[Time Frame: 20 min]
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Secondary Outcome(s)
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Agitation level at 20,40 and 60 min
[Time Frame: 20, 40 and 60mn]
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Need for rescue medication
[Time Frame: any time]
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Sedation duration
[Time Frame: No]
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Success of treatment at 40 and 60 min
[Time Frame: 40 and 60 mn]
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treatment failure
[Time Frame: one hour after treatment]
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Secondary ID(s)
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French state grant
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2004/055/HP
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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