Staccato Granisetron® (AZ 010) for the Treatment of Cyclic Vomiting Syndrome
NCT ID: NCT04645953
Last Updated: 2025-06-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
150 participants
INTERVENTIONAL
2021-02-05
2022-07-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1mg AZ010
Single orally-inhaled dose
1mg AZ010
Subjects who received a single inhaled dose (1mg)
3mg AZ010
Single orally-inhaled dose
3mg AZ-010
Subjects who received a single inhaled dose (3mg)
Placebo
Single orally-inhaled dose
Staccato Placebo
Subject who received a single inhaled dose (Staccato Placebo)
Interventions
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3mg AZ-010
Subjects who received a single inhaled dose (3mg)
1mg AZ010
Subjects who received a single inhaled dose (1mg)
Staccato Placebo
Subject who received a single inhaled dose (Staccato Placebo)
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
60 Years
ALL
Yes
Sponsors
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Alexza Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Larry Carter, PhD
Role: STUDY_DIRECTOR
Alexza Pharmaceuticals, Inc.
Locations
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Om Research
Lancaster, California, United States
Axis Clinical Trials
Los Angeles, California, United States
Precision Research Institute, LLC
San Diego, California, United States
University of South Florida
Tampa, Florida, United States
Summit Clinical Studies
Athens, Georgia, United States
Infinite Clinical Trials
Morrow, Georgia, United States
Kansas University Medical Center
Kansas City, Kansas, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
NY Scientific
Brooklyn, New York, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
New Phase Research & Development, LLC
Knoxville, Tennessee, United States
Baylor College of Medicine
Houston, Texas, United States
Pioneer Research Solutions
Houston, Texas, United States
Sante Clinical Research
Kerrville, Texas, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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AMDC 010-201
Identifier Type: -
Identifier Source: org_study_id
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