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

Alexza Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Cyclic Vomiting Syndrome

Treatments: Combination Product: Staccato Placebo; Combination Product: 3mg AZ-010; Combination Product: 1mg AZ010

Study type: Interventional

Funder types: Industry

Identifiers

NCT04645953

AMDC 010-201

Details and patient eligibility

About

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.

Full 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

Enrollment: 151 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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151 participants in 3 patient groups

1mg AZ010

Experimental group

Description:

Single orally-inhaled dose

Treatment:

Combination Product: 1mg AZ010

3mg AZ010

Experimental group

Description:

Single orally-inhaled dose

Treatment:

Combination Product: 3mg AZ-010

Placebo

Experimental group

Description:

Single orally-inhaled dose

Treatment:

Combination Product: Staccato Placebo