Study to Assess the Efficacy of VLY-686 in Relieving Symptoms of Gastroparesis
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Assess the Efficacy of VLY-686 (Tradipitant) in Relieving Symptoms of Gastroparesis
1 other identifier
interventional
152
1 country
38
Brief Summary
This is a multicenter, randomized, double-blind, placebo-controlled study to be conducted in the United States. One hundred fifty (150) subjects diagnosed with gastroparesis, who satisfy the selection criteria for the study, will be randomized to one of two treatment groups, active or placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2016
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 15, 2016
CompletedFirst Posted
Study publicly available on registry
November 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedResults Posted
Study results publicly available
August 6, 2024
CompletedAugust 6, 2024
July 1, 2024
2 years
November 15, 2016
March 5, 2024
July 15, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Average Nausea Severity
The Gastroparesis Core Symptom Daily Diary (GCSDD) is a patient reported diary that asks patients to rate the worst occurrence of each cardinal symptom of gastroparesis (nausea severity, early satiety, postprandial fullness, bloating, and abdominal pain) in the past 24 hours on a Likert scale from 0 (no symptoms) to 5 (very severe). Change from baseline in average nausea severity score is calculated as the weekly average post value minus baseline value of the daily nausea severity score from the GCSDD. A negative change indicates improvement.
4 weeks
Secondary Outcomes (6)
Weekly % Nausea-Free Days
4 weeks
Daily Average Vomiting Frequency, Change From Baseline
4 weeks
Gastroparesis Cardinal Symptom Index (GCSI), Change From Baseline
4 weeks
PAGI-SYM, Change From Baseline
4 weeks
CGI-S, Change From Baseline
4 weeks
- +1 more secondary outcomes
Study Arms (2)
Study Drug
EXPERIMENTALVLY-686 (Tradipitant) oral capsule for 4 weeks.
Placebo
PLACEBO COMPARATORPlacebo oral capsule for 4 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosed with gastroparesis;
- Subjects must agree to the use of contraception
- Ability and acceptance to provide written informed consent;
- Willing to participate in the pharmacogenomics sample collection;
- Willing and able to comply with all study requirements and restrictions
- Willing to not participate in any other interventional trial for the duration of their participation.
You may not qualify if:
- Another active disorder or treatment which could explain or contribute to symptoms in the opinion of the Investigator (including but not limited to gastric malignancy, neurological disorder, or heavy doses of strong anticholinergics);
- Pregnancy or nursing;
- History of intolerance and/or hypersensitivity to medications similar to VLY-686 (Tradipitant) and its accompanying excipients;
- Use of another NK1 antagonist or palonosetron;
- Exposure to any investigational medication, including placebo, within 60 days of the Baseline Visit;
- Any other reason as determined by the Investigator which may lead to an unfavorable risk-benefit of study participation, may interfere with study compliance, or may confound study results.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (38)
Vanda Investigational Site
Dothan, Alabama, 36305, United States
Vanda Investigational Site
Huntsville, Alabama, 35801, United States
Vanda Investigational Site
Tucson, Arizona, 85712, United States
Vanda Investigational Site
Little Rock, Arkansas, 72211, United States
Vanda Investigational Site
Chula Vista, California, 91910, United States
Vanda Investigational Site
Los Angeles, California, 90095, United States
Vanda Investigational Site
Palo Alto, California, 94305, United States
Vanda Investigational Site
San Francisco, California, 94115, United States
Vanda Investigational Site
Jacksonville, Florida, 32256, United States
Vanda Investigational Site
Largo, Florida, 33777, United States
Vanda Investigational Site
Miami, Florida, 33134, United States
Vanda Investigational Site
Athens, Georgia, 30607, United States
Vanda Investigational Site
Elgin, Illinois, 60123, United States
Vanda Investigational Site
Indianapolis, Indiana, 46202, United States
Vanda Investigational Site
Louisville, Kentucky, 40202, United States
Vanda Investigational Site
Marrero, Louisiana, 70072, United States
Vanda Investigational Site
Chevy Chase, Maryland, 20815, United States
Vanda Investigational Site
Boston, Massachusetts, 02114, United States
Vanda Investigational Site
Boston, Massachusetts, 02215, United States
Vanda Investigational Site
Wyoming, Michigan, 49519, United States
Vanda Investigational Site
Minneapolis, Minnesota, 55114, United States
Vanda Investigational Site
Pascagoula, Mississippi, 39564, United States
Vanda Investigational Site
St Louis, Missouri, 63104, United States
Vanda Investigational Site
Great Neck, New York, 11023, United States
Vanda Investigational Site
New York, New York, 10028, United States
Vanda Investigational Site
Raleigh, North Carolina, 27612, United States
Vanda Investigational Site
Salisbury, North Carolina, 28144, United States
Vanda Investigational Site
Huber Heights, Ohio, 45424, United States
Vanda Investigational Site
Mentor, Ohio, 44060, United States
Vanda Investigational Site
Tulsa, Oklahoma, 74104, United States
Vanda Investigational Site
Philadelphia, Pennsylvania, 19140, United States
Vanda Investigational Site
Chattanooga, Tennessee, 37421, United States
Vanda Investigational Site
Jackson, Tennessee, 38305, United States
Vanda Investigational Site
Nashville, Tennessee, 37211, United States
Vanda Investigational Site
El Paso, Texas, 79905, United States
Vanda Investigational Site
Houston, Texas, 77030, United States
Vanda Investigational Site
Richardson, Texas, 75082, United States
Vanda Investigational Site
Norfolk, Virginia, 23502, United States
Related Publications (1)
Carlin JL, Lieberman VR, Dahal A, Keefe MS, Xiao C, Birznieks G, Abell TL, Lembo A, Parkman HP, Polymeropoulos MH. Efficacy and Safety of Tradipitant in Patients With Diabetic and Idiopathic Gastroparesis in a Randomized, Placebo-Controlled Trial. Gastroenterology. 2021 Jan;160(1):76-87.e4. doi: 10.1053/j.gastro.2020.07.029. Epub 2020 Jul 18.
PMID: 32693185DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Studies are needed to determine the mechanisms by which tradipitant reduces nausea and vomiting, and powered to assess idiopathic and diabetic gastroparesis separately.
Results Point of Contact
- Title
- Vanda Pharmaceuticals
- Organization
- Vanda Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 15, 2016
First Posted
November 22, 2016
Study Start
November 1, 2016
Primary Completion
November 1, 2018
Study Completion
December 1, 2018
Last Updated
August 6, 2024
Results First Posted
August 6, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share