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NCT04645953 · ClinicalTrials.gov registry record · Phase 2
Staccato Granisetron® (AZ 010) for the Treatment of Cyclic Vomiting Syndrome
A Phase 2 study, sponsored by Alexza Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
NCT04645953: Completed Phase 2 study, sponsored by Alexza Pharmaceuticals.
NCT04645953 is a Phase 2 study that has completed, run by Alexza Pharmaceuticals. The registered enrollment target is 150 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04645953, a Phase 2 study, has completed, sponsored by Alexza Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
Study Summary
This is a multicenter, randomized, double-blind, parallel group, placebo-controlled, efficacy and safety study of adult outpatients diagnosed with CVS and experiencing recurring episodes of stereotypical vomiting.
Primary Outcome
The primary efficacy endpoint for this study was the number vomiting/retching events in the two hours following initial treatment. Patients recorded the number of vomiting and retching events that they experienced which occurred 2 hours post dose. Observations occurred at 4 time points: 30 minutes post-dose, 1 hour post-dose, 90 minutes post-dose, and 2 hours post-dose. While each treatment group contained 47-49 patients, only 22-35 patients per treatment group (\~45-70%) recorded vomiting/retc
Interventions
- COMBINATION_PRODUCT 3mg AZ-010
- COMBINATION_PRODUCT 1mg AZ010
- COMBINATION_PRODUCT Staccato Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2021-02-05 |
| Est. Completion | 2022-07-26 |
| Phase | Phase 2 |
What the finished NCT04645953 record still lists
NCT04645953 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% higher).
The record links to 0 conditions, and to 3 interventions - of which 3mg AZ-010 is the first listed.
NCT04645953 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04645953 about?
NCT04645953 is a clinical study titled "Staccato Granisetron® (AZ 010) for the Treatment of Cyclic Vomiting Syndrome". This is a multicenter, randomized, double-blind, parallel group, placebo-controlled, efficacy and safety study of adult outpatients diagnosed with CVS and experiencing recurring episodes of stereotypical vomiting.
What is the current status of trial NCT04645953?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2021-02-05. Estimated completion is 2022-07-26.
What interventions are being tested in trial NCT04645953?
The interventions under investigation include: 3mg AZ-010 (COMBINATION_PRODUCT), 1mg AZ010 (COMBINATION_PRODUCT), Staccato Placebo (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04645953?
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 NCT04645953's enrollment target sits among peer trials
150 455th of 2000 higher than 1,510 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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