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Staccato Loxapine in Agitated Patients With Schizophrenia

NCT00628589 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 344

Last updated 2017-07-26

Study results available
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Summary

Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in schizophrenic patients

Conditions

  • Patients With Schizophrenia and Acute Agitation

Interventions

DRUG

Inhaled loxapine 5 mg

Inhaled loxapine 5 mg

DRUG

Inhaled loxapine 10 mg

Inhaled loxapine 10 mg

DRUG

Inhaled placebo

Inhaled placebo

Sponsors & Collaborators

  • Alexza Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Robert S Fishman, MD · Alexza Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2008-05-31
Completion
2008-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00628589 on ClinicalTrials.gov