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

This is an interventional treatment trial for Cyclic Vomiting Syndrome focused on measuring Cyclic Vomiting Syndrome, CVS, Vomiting, Retching, Abdominal migraine, Nausea, Stomach pain, Unexplained vomiting, Functional GI Disorder, CVSHOPE.com, Throwing up, Puking, Dry heaving, Food poisoning, Episodes, Repeated food poisoning Read More

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.