MedTrace Logo

Staccato Loxapine in Agitated Patients With Bipolar Disorder

NCT00721955 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 314

Last updated 2017-07-26

Study results available
· View outcomes & findings →

Summary

Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in bipolar 1 disorder patients.

Conditions

Interventions

DRUG

Inhaled Placebo

Inhaled loxapine Placebo, may repeat after 2 hours x 2

DRUG

Inhaled loxapine 5 mg

Inhaled Staccato loxapine 5 mg, may repeat after 2 hours x 2

DRUG

Inhaled loxapine 10 mg

Inhaled Staccato loxapine 10 mg, may repeat after 2 hours x 2

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
2008-07-31
Primary Completion
2008-10-31
Completion
2008-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00721955 on ClinicalTrials.gov