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

Phase 2

Completed

• Conditions: Cyclic Vomiting Syndrome
• Interventions: Combination Product: 1mg AZ010; Combination Product: Staccato Placebo; Combination Product: 3mg AZ-010

• Registration Number: NCT04645953
• Lead Sponsor: Alexza Pharmaceuticals, Inc.

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.

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 Timeline

• Study First Submitted: 2020-11-16
• Study First Submitted QC: 2020-11-25
• Study First Posted: 2020-11-27
• Study Start: 2021-02-11
• Primary Completion: 2022-07-19
• Study Completion: 2022-07-19
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-26
• Last Update Posted: 2022-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1mg AZ010	1mg AZ010	Single orally-inhaled dose
Placebo	Staccato Placebo	Single orally-inhaled dose
3mg AZ010	3mg AZ-010	Single orally-inhaled dose

Primary Outcome Measures

Name	Time	Method
The number of vomiting/retching events in the 2 hours following treatment.	24 hours

Secondary Outcome Measures

Name	Time	Method
Number of adverse events as a measure of safety	24 hours

Trial Locations

Locations (18)

Pioneer Research Solutions; 🇺🇸 Houston, Texas, United States

Om Research; 🇺🇸 Lancaster, California, United States

Summit Clinical Studies; 🇺🇸 Athens, Georgia, United States

Sante Clinical Research; 🇺🇸 Kerrville, Texas, United States

Kansas University Medical Center; 🇺🇸 Kansas City, Kansas, United States

Axis Clinical Trials; 🇺🇸 Los Angeles, California, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

University of South Florida; 🇺🇸 Tampa, Florida, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

New Phase Research & Development, LLC; 🇺🇸 Knoxville, Tennessee, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Infinite Clinical Trials; 🇺🇸 Morrow, Georgia, United States

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States

Precision Research Institute, LLC; 🇺🇸 San Diego, California, United States

NY Scientific; 🇺🇸 Brooklyn, New York, United States

Temple University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States