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

AMDC 010-201

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.

2021-02-11

2022-07-19

2022-07-19

Completed

Early phase I

151

Inclusion Criteria: * Adult males and females between 18 and 60 years of age, inclusive at the time of signing the informed consent document. * Diagnosis of cyclic vomiting syndrome (CVS) using the Rome IV diagnostic criteria. * Otherwise healthy, as determined by the responsible physician, based on a medical evaluation including history, physical examination, vital signs, electrocardiograms (ECGs) and laboratory tests assessed at the screening visit * Negative urine tests for selected drugs of abuse and alcohol breath test at Screening. Exclusion Criteria: * Any significant medical or psychiatric condition that could, in the Investigator's opinion, compromise the subject's safety or interfere with the completion of this protocol. * Any condition, including the presence of laboratory abnormalities or pulmonary condition, which according to the Investigator places the subject at unacceptable risk if he/she were to participate in the study. * A diagnosis of any gastrointestinal disorder other than CVS that in the judgement of the Investigator could compromise the subject's safety or interfere with the interpretation of safety or efficacy data.

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2022-09-27