NCT04645953

Staccato Granisetron® (AZ 010) for the Treatment of Cyclic Vomiting Syndrome

A Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Efficacy of Staccato Granisetron (AZ-010) for the Acute Treatment of Moderate to Severe Cyclic Vomiting Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Alexza Pharmaceuticals, Inc. · Unknown
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed description

A Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Efficacy of Staccato Granisetron (AZ-010) for the Acute Treatment of Moderate to Severe Cyclic Vomiting Syndrome

Conditions

• Cyclic Vomiting Syndrome

Interventions

Type	Name	Description
COMBINATION_PRODUCT	3mg AZ-010	Subjects who received a single inhaled dose (3mg)
COMBINATION_PRODUCT	1mg AZ010	Subjects who received a single inhaled dose (1mg)
COMBINATION_PRODUCT	Staccato Placebo	Subject who received a single inhaled dose (Staccato Placebo)

Timeline

• Start date: 2021-02-05
• Primary completion: 2022-07-26
• Completion: 2022-07-26
• First posted: 2020-11-27
• Last updated: 2025-06-11
• Results posted: 2025-06-11

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study