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

Cyclic Vomiting Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04645953
• Other study ID #: AMDC 010-201
• Status: Completed
• Phase: Phase 2
• Start date: February 11, 2021
• Est. completion date: July 19, 2022

Study information

• Verified date: September 2022
• Source: Alexza Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: July 19, 2022
• Est. primary completion date: July 19, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cyclic Vomiting Syndrome
• Syndrome
• Vomiting

Intervention

Combination Product:
• 3mg AZ-010
Subject will receive a single inhaled dose (3mg)
• 1mg AZ010
Subject will receive a single inhaled dose (1mg)
• Staccato Placebo
Subject will receive a single inhaled dose (Staccato Placebo)

Locations

Country	Name	City	State
United States	Summit Clinical Studies	Athens	Georgia
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	NY Scientific	Brooklyn	New York
United States	Henry Ford Health System	Detroit	Michigan
United States	Baylor College of Medicine	Houston	Texas
United States	Pioneer Research Solutions	Houston	Texas
United States	Kansas University Medical Center	Kansas City	Kansas
United States	Sante Clinical Research	Kerrville	Texas
United States	New Phase Research & Development, LLC	Knoxville	Tennessee
United States	Om Research	Lancaster	California
United States	Axis Clinical Trials	Los Angeles	California
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Infinite Clinical Trials	Morrow	Georgia
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	Precision Research Institute, LLC	San Diego	California
United States	University of South Florida	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Alexza Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of vomiting/retching events in the 2 hours following treatment.		24 hours
Secondary	Number of adverse events as a measure of safety		24 hours

External Links

•   CVS study web-site