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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: Completed Phase 2 study, sponsored by Alexza Pharmaceuticals.
NCT00369577 is a Phase 2 study that has completed, run by Alexza Pharmaceuticals. The registered enrollment target is 129 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (min) to 7 (max). The PANSS-EC, the sum of these 5 subscales, thus ranges from 5 to 35. Individuals were eligible if they had a PANSS-EC of ≥14 (out of 35) and a score ≥4 (out of 7) on at least 1 of the 5 items.
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 |
What the finished NCT00369577 record still lists
NCT00369577 is an interventional study that assigns participants to a tested intervention. The registered 129 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Inhaled Placebo is the first listed.
NCT00369577 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00369577's enrollment target sits among peer trials
129 553rd of 2000 higher than 1,448 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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