Staccato Granisetron® (AZ 010) for the Treatment of Cyclic Vomiting Syndrome
Completed · Phase 2 · Has a placebo group
Conditions studied: Cyclic Vomiting Syndrome
In brief
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.
Key facts
- Study ID
- NCT04645953
- Run by
- Alexza Pharmaceuticals, Inc.
- People needed
- 150
- Starts
- 2021-02-05
- Expected to finish
- 2022-07-26
- Last updated by the study team
- 2025-06-11
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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