Staccato Granisetron® (AZ 010) for the Treatment of Cyclic Vomiting Syndrome
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ClinicalTrials.gov Identifier: NCT04645953 |
Recruitment Status :
Completed
First Posted : November 27, 2020
Last Update Posted : September 27, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cyclic Vomiting Syndrome | Combination Product: 3mg AZ-010 Combination Product: 1mg AZ010 Combination Product: Staccato Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 151 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Masking Description: | Double Blind |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | February 11, 2021 |
Actual Primary Completion Date : | July 19, 2022 |
Actual Study Completion Date : | July 19, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: 1mg AZ010
Single orally-inhaled dose
|
Combination Product: 1mg AZ010
Subject will receive a single inhaled dose (1mg) |
Experimental: 3mg AZ010
Single orally-inhaled dose
|
Combination Product: 3mg AZ-010
Subject will receive a single inhaled dose (3mg) |
Experimental: Placebo
Single orally-inhaled dose
|
Combination Product: Staccato Placebo
Subject will receive a single inhaled dose (Staccato Placebo) |
- The number of vomiting/retching events in the 2 hours following treatment. [ Time Frame: 24 hours ]
- Number of adverse events as a measure of safety [ Time Frame: 24 hours ]

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04645953

Study Director: | Larry Carter, PhD | Alexza Pharmaceuticals, Inc. |
Responsible Party: | Alexza Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT04645953 |
Other Study ID Numbers: |
AMDC 010-201 |
First Posted: | November 27, 2020 Key Record Dates |
Last Update Posted: | September 27, 2022 |
Last Verified: | September 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | Yes |
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 |
Syndrome Vomiting Disease Pathologic Processes Signs and Symptoms, Digestive |