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

Launched by ALEXZA PHARMACEUTICALS, INC. · Nov 25, 2020

Keywords

ClinConnect Summary

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

Gender

ALL

Eligibility criteria

• 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.