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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04645953
Recruitment Status : Recruiting
First Posted : November 27, 2020
Last Update Posted : April 5, 2021
Sponsor:
Information provided by (Responsible Party):
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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 11, 2021
Estimated Primary Completion Date : December 15, 2021
Estimated Study Completion Date : January 15, 2022

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. The number of vomiting/retching events in the 2 hours following treatment. [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Number of adverse events as a measure of safety [ Time Frame: 24 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04645953


Contacts
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Contact: Barrie Weeks 650-944-7156 bweeks@alexza.com

Locations
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United States, California
Om Research Recruiting
Lancaster, California, United States, 93535
Contact: Nancy Toc    661-388-2239 ext 08    info@omclinicaltrials.com   
Principal Investigator: Jatinder S. Pruthi, MD         
Axis Clinical Trials Recruiting
Los Angeles, California, United States, 90036
Contact: Elianet De La Cruz    310-289-8242    eli@axistoday.com   
Principal Investigator: Lydie Hazan, MD         
Precision Research Institute, LLC Not yet recruiting
San Diego, California, United States, 92114
Contact: Josie Summers    619-501-0371 ext 309    josie@prisandiego.com   
Principal Investigator: Taddese Desta, MD         
United States, Florida
University of South Florida Not yet recruiting
Tampa, Florida, United States, 33606
Contact: Thanh Tran    813-844-8544    tqtran@usf.edu   
Principal Investigator: Vic Velanovich, MD         
United States, Georgia
Summit Clinical Studies Recruiting
Athens, Georgia, United States, 30607
Contact: Barbara Wilson, MSc CROM    706-400-4262    info@summitclinicalstudies.com   
Principal Investigator: Jeffrey Williams, MD         
United States, Indiana
Indiana University Health Not yet recruiting
Indianapolis, Indiana, United States, 46202
Contact: Anita Gupta    317-274-3253    anigupta@iu.edu   
Principal Investigator: Robert Siwiec, MD         
United States, Kentucky
University of Louisville Not yet recruiting
Louisville, Kentucky, United States, 40202
Contact: Annette Robinson       annette.robinson@louisville.edu   
Principal Investigator: Thomas Abell, MD         
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Rao Fatima    617-724-0480    frao@mgh.harvard.edu   
Principal Investigator: Braden Kuo, MD         
United States, Michigan
Henry Ford Health System Not yet recruiting
Detroit, Michigan, United States, 48202
Contact: Kathryn Wilson    313-404-9110    kwilso10@hfhs.org   
Principal Investigator: Joseph Miller, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Margaret Breen-Lyles    507-293-0237    breen-lyles.margaret@mayo.deu   
Principal Investigator: Madhusudan Grover, MD         
United States, Pennsylvania
Temple University Hospital Not yet recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Bradley Fesi    215-707-2411    bradley.fesi@temple.edu   
Principal Investigator: Henry Parkman, MD         
United States, Tennessee
New Phase Research & Development, LLC Recruiting
Knoxville, Tennessee, United States, 37909
Contact: Jessica Kidd    865-200-8364    jkidd@newphaseonline.com   
Principal Investigator: Evelyne M. Davidson, MD         
United States, Texas
Baylor College of Medicine Not yet recruiting
Houston, Texas, United States, 77030
Contact: Michael Mercado    713-798-3606    michael.mercado@bcm.edu   
Principal Investigator: Mohamed Othman, MD         
Sante Clinical Research Recruiting
Kerrville, Texas, United States, 78028
Contact: Danielle Monclova    830-890-5171    dmonclova@santeresearch.net   
Principal Investigator: Carlos Menendez, MD         
United States, Wisconsin
Medical College of Wisconsin Not yet recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Alexandra Bruss    414-805-7128    abruss@mcw.edu   
Principal Investigator: Thangam Venkatesan, MD         
Sponsors and Collaborators
Alexza Pharmaceuticals, Inc.
Investigators
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Study Director: Barrie Weeks, BA Alexza Pharmaceuticals, Inc.
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Responsible Party: Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04645953    
Other Study ID Numbers: AMDC 010-201
First Posted: November 27, 2020    Key Record Dates
Last Update Posted: April 5, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Syndrome
Vomiting
Disease
Pathologic Processes
Signs and Symptoms, Digestive