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

Purpose

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

  • Cyclic Vomiting Syndrome

Eligibility

Eligible Ages
Between 18 Years and 60 Years
Eligible Sex
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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
Double Blind

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
1mg AZ010 		Single orally-inhaled dose
  • Combination Product: 1mg AZ010
    Subjects who received a single inhaled dose (1mg)
Experimental
3mg AZ010 		Single orally-inhaled dose
  • Combination Product: 3mg AZ-010
    Subjects who received a single inhaled dose (3mg)
Experimental
Placebo 		Single orally-inhaled dose
  • Combination Product: Staccato Placebo
    Subject who received a single inhaled dose (Staccato Placebo)

More Details

Status
Completed
Sponsor
Alexza Pharmaceuticals, Inc.

Study Contact

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