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NCT00369577 · ClinicalTrials.gov registry record · Phase 2
Staccato Loxapine in Agitation (Proof of Concept)
A Phase 2 study, sponsored by Alexza Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 129
- Enrollment target
NCT00369577 is a Phase 2 study that has completed, run by Alexza Pharmaceuticals. The registered enrollment target is 129 participants.
The verdict
NCT00369577, a Phase 2 study, has completed, sponsored by Alexza Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 129 participants
- Enrollment target
Study Summary
The purpose of this study is to assess efficacy and safety of Staccato Loxapine in the treatment of acute agitation in schizophrenic patients. The study will be conducted in 120 agitated schizophrenic patients - either newly admitted to a hospital setting or a research unit for acute agitation or already in hospital for chronic underlying conditions. Patients meeting entry criteria will be randomized to one of two doses of Staccato Loxapine or to Staccato Placebo. Following administration of study drug, assessment of agitation state will be conducted at serial time points using standard agitation scales over a 24 hour period.
Interventions
- DRUG Inhaled Placebo
- DRUG Inhaled Loxapine 10 mg
- DRUG Inhaled Loxapine 5 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 129 participants |
| Start Date | 2006-08 |
| Est. Completion | 2007-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00369577
The ClinicalTrials.gov registry entry for NCT00369577 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 129 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alexza Pharmaceuticals, which has 22 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Inhaled Placebo is the first listed.
NCT00369577 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00369577 about?
NCT00369577 is a clinical study titled "Staccato Loxapine in Agitation (Proof of Concept)". The purpose of this study is to assess efficacy and safety of Staccato Loxapine in the treatment of acute agitation in schizophrenic patients. The study will be conducted in 120 agitated schizophrenic patients - either newly admitted to a hospital setting or a research unit for acute agitation or al...
What is the current status of trial NCT00369577?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 129 participants. The study started on 2006-08. Estimated completion is 2007-01.
What interventions are being tested in trial NCT00369577?
The interventions under investigation include: Inhaled Placebo (DRUG), Inhaled Loxapine 10 mg (DRUG), Inhaled Loxapine 5 mg (DRUG).
Who is sponsoring clinical trial NCT00369577?
This trial is sponsored by Alexza Pharmaceuticals, which has 22 total clinical trials registered on ClinicalTrials.gov.
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