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

Sponsor

Alexza Pharmaceuticals, Inc. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04645953

Collaborator

(none)

150

Enrollment

Locations

Arms

17.2

Anticipated Duration (Months)

8.3

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

Anticipated Enrollment :

150 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 :

Feb 11, 2021

Anticipated Primary Completion Date :

Jul 19, 2022

Anticipated Study Completion Date :

Jul 19, 2022

Arms and Interventions

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)

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

Primary Outcome Measures

The number of vomiting/retching events in the 2 hours following treatment. [24 hours]

Secondary Outcome Measures

Number of adverse events as a measure of safety [24 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Om Research	Lancaster	California	United States	93535
2	Axis Clinical Trials	Los Angeles	California	United States	90036
3	Precision Research Institute, LLC	San Diego	California	United States	92114
4	University of South Florida	Tampa	Florida	United States	33606
5	Summit Clinical Studies	Athens	Georgia	United States	30607
6	Infinite Clinical Trials	Morrow	Georgia	United States	30260
7	Kansas University Medical Center	Kansas City	Kansas	United States	66160
8	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
9	Henry Ford Health System	Detroit	Michigan	United States	48202
10	Mayo Clinic	Rochester	Minnesota	United States	55905
11	NY Scientific	Brooklyn	New York	United States	11235
12	Temple University Hospital	Philadelphia	Pennsylvania	United States	19140
13	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213
14	New Phase Research & Development, LLC	Knoxville	Tennessee	United States	37909
15	Baylor College of Medicine	Houston	Texas	United States	77030
16	Pioneer Research Solutions	Houston	Texas	United States	77099
17	Sante Clinical Research	Kerrville	Texas	United States	78028
18	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226