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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04645953
Recruitment Status : Completed
First Posted : November 27, 2020
Last Update Posted : September 27, 2022
Sponsor:
Information provided by (Responsible Party):
Alexza Pharmaceuticals, Inc.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cyclic Vomiting Syndrome Combination Product: 3mg AZ-010 Combination Product: 1mg AZ010 Combination Product: Staccato Placebo Phase 2

Detailed Description:
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
Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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)


Outcome Measures
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Primary Outcome Measures :
  1. The number of vomiting/retching events in the 2 hours following treatment. [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Number of adverse events as a measure of safety [ Time Frame: 24 hours ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Alexza Pharmaceuticals, Inc.
Investigators
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Study Director: Larry Carter, PhD Alexza Pharmaceuticals, Inc.
More Information
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Additional Information:

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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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Alexza Pharmaceuticals, Inc.:
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
Additional relevant MeSH terms:
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Syndrome
Vomiting
Disease
Pathologic Processes
Signs and Symptoms, Digestive