drugset / Trial / NCT00290082

Randomized Double-blind Trial of Midazolam and Loxapine in Agitated Patients

NCT00290082

Phase 3 Terminated 120 enrolled University Hospital, Rouen
RandomizedParallel-groupDouble-blindTreatment

Summary

Neuroleptics are used since a long time in the management of severely agitated patients. Loxapine is routinely used in our country, with, to our knowledge no severe adverse event reported, in this indication. However, recently, benzodiazepines have appeared interesting in agitated patients, with the use of midazolam. The aim of this study is to compare midazolam to loxapine in the treatment of severe agitated patients admitted in the emergency department.

Timeline

Start
2005-12
Primary completion
2007-10
Completion
2007-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Midazolam Small molecule 0.1 mg/kg
Comparator Midazolam Small molecule 0.5 mg/kg
Comparator Midazolam Small molecule 1 mg/kg
Comparator loxapine Small molecule 2.5 mg/kg
Comparator loxapine Small molecule 12.5 mg/kg
Comparator loxapine Small molecule 25 mg/kg

Indications

No indication recorded.