At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 150 enrolled
Drug / intervention
3mg AZ-010 +2 morecombination
Likely dose
3mg AZ-010from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating 3mg AZ-010, 1mg AZ010, and 1 other intervention for Cyclic Vomiting Syndrome. Completed, enrolled 150 participants across 18 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCyclic Vomiting Syndrome
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
202120222023202420252026
First PostedNov 2020
Enrollment StartFeb 2021
Primary CompletionJul 2022
TodayJul 2026
First PostedNov 27, 2020
Enrollment StartFeb 5, 2021
Primary CompletionJul 26, 2022
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 5.6 years ago
Interventions
3mg AZ-010combination
Subjects who received a single inhaled dose (3mg)
1mg AZ010combination
Subjects who received a single inhaled dose (1mg)
Staccato Placebocombination
Subject who received a single inhaled dose (Staccato Placebo)