drugset / Trial / NCT04645953
Staccato Granisetron® (AZ 010) for the Treatment of Cyclic Vomiting Syndrome
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2021-02-05
- Primary completion
- 2022-07-26
- Completion
- 2022-07-26
Outcome
Missed primary endpoint
registry analysis (superiority test); 1mg AZ010; p = 0.7024; ANOVA NCT04645953 ↗
registry analysis (superiority test); 3mg AZ010; p = 0.2051; ANOVA NCT04645953 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Granisetron | Other / unclassified | 1 mg | Inhaled |
| Subject | Granisetron | Other / unclassified | 3 mg | Inhaled |