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

NCT04645953 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-06-11

Study results available
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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.

Conditions

  • Cyclic Vomiting Syndrome

Interventions

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)

Sponsors & Collaborators

  • Alexza Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Larry Carter, PhD · Alexza Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-05
Primary Completion
2022-07-26
Completion
2022-07-26
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04645953 on ClinicalTrials.gov