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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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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

Conditions
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Cyclic Vomiting Syndrome

Intervention / Treatment
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* Combination Product: 3mg AZ-010
* Combination Product: 1mg AZ010
* Combination Product: Staccato Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1mg AZ010<br>Single orally-inhaled dose | Combination Product: 1mg AZ010<br>* Subject will receive a single inhaled dose (1mg)<br>|
| Experimental: 3mg AZ010<br>Single orally-inhaled dose | Combination Product: 3mg AZ-010<br>* Subject will receive a single inhaled dose (3mg)<br>|
| Experimental: Placebo<br>Single orally-inhaled dose | Combination Product: Staccato Placebo<br>* Subject will receive a single inhaled dose (Staccato Placebo)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of vomiting/retching events in the 2 hours following treatment. |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events as a measure of safety |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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