Status:
COMPLETED
Staccato Loxapine in Agitated Patients With Schizophrenia
Lead Sponsor:
Alexza Pharmaceuticals, Inc.
Conditions:
Patients With Schizophrenia and Acute Agitation
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in schizophrenic patients
Detailed Description
This is an in-clinic, multi-center, randomized, double-blind, placebo-controlled study of 2 dose levels of Staccato Loxapine, 5 and 10 mg. Patients may receive up to 3 doses of study drug in a 24-hour...
Eligibility Criteria
Inclusion
- Male and female adult patients with schizophrenia and acute agitation
Exclusion
- Agitation caused primarily by acute intoxication
- History of drug or alcohol dependence
- Treatment with benzodiazepines or other hypnotics within 4 hours prior to study drug administration
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
344 Patients enrolled
Trial Details
Trial ID
NCT00628589
Start Date
February 1 2008
End Date
May 1 2008
Last Update
July 26 2017
Active Locations (1)
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1
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30308