Evaluating the Safety and Efficacy of Tradipitant vs. Placebo in Idiopathic and Diabetic Gastroparesis
NCT ID: NCT04028492
Last Updated: 2025-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
992 participants
INTERVENTIONAL
2019-08-20
2025-02-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Tradipitant
Oral Capsule
Tradipitant
BID
Placebo
Oral Capsule
Placebo
BID
Open Label Tradipitant
Oral Capsule
Open Label Tradipitant
BID
Interventions
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Tradipitant
BID
Placebo
BID
Open Label Tradipitant
BID
Eligibility Criteria
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Inclusion Criteria
* Demonstrated delayed gastric emptying
* Presence of moderate to severe nausea
* Body Mass Index (BMI) of ≥18 and ≤40 kg/m2
Exclusion Criteria
* A positive test for drugs of abuse at the screening or evaluation visits;
* Exposure to any investigational medication in the past 60 days
* Gastrectomy, fundoplication, vagotomy, pyloroplasty, bariatric surgery, or gastric stimulation device surgically implanted within the last year
18 Years
70 Years
ALL
No
Sponsors
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Vanda Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Vanda Pharmaceuticals
Role: STUDY_DIRECTOR
Vanda Pharmaceuticals
Locations
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Vanda Investigational Site
Birmingham, Alabama, United States
Vanda Investigational Site
Peoria, Arizona, United States
Vanda Investigational Site
Little Rock, Arkansas, United States
Vanda Investigational Site
Chula Vista, California, United States
Vanda Investigational Site
La Jolla, California, United States
Vanda Investigational Site
Los Angeles, California, United States
Vanda Investigational Site
Los Angeles, California, United States
Vanda Investigational Site
Maitland, Florida, United States
Vanda Investigational Site
Palmetto Bay, Florida, United States
Vanda Investigational Site
Tampa, Florida, United States
Vanda Investigational Site
Morrow, Georgia, United States
Vanda Investigational Site
Wauconda, Illinois, United States
Vanda Investigational Site
West Des Moines, Iowa, United States
Vanda Investigational Site
Wichita, Kansas, United States
Vanda Investigational Site
Louisville, Kentucky, United States
Vanda Investigational Site
Marrero, Louisiana, United States
Vanda Investigational Site
Chevy Chase, Maryland, United States
Vanda Investigational Site
Boston, Massachusetts, United States
Vanda Investigational Site
Boston, Massachusetts, United States
Vanda Investigational Site
Chesterfield, Missouri, United States
Vanda Investigational Site
Las Vegas, Nevada, United States
Vanda Investigational Site
Brooklyn, New York, United States
Vanda Investigational Site
Charlotte, North Carolina, United States
Vanda Investigational Site
Raleigh, North Carolina, United States
Vanda Investigational Site
Columbus, Ohio, United States
Vanda Investigational Site
Huber Heights, Ohio, United States
Vanda Investigational Site
Edmond, Oklahoma, United States
Vanda Investigational Site
Tulsa, Oklahoma, United States
Vanda Investigational Site
Philadelphia, Pennsylvania, United States
Vanda Investigational Site
Chattanooga, Tennessee, United States
Vanda Investigational Site
Nashville, Tennessee, United States
Vanda Investigational Site
Houston, Texas, United States
Vanda Investigational Site
Houston, Texas, United States
Vanda Investigational Site
Plano, Texas, United States
Vanda Investigational Site
San Antonio, Texas, United States
Vanda Investigational Site
Salt Lake City, Utah, United States
Countries
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References
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Carlin JL, Polymeropoulos C, Camilleri M, Lembo A, Fisher M, Kupersmith C, Madonick D, Moszczynski P, Smieszek S, Xiao C, Birznieks G, Polymeropoulos MH. The Efficacy of Tradipitant in Patients With Diabetic and Idiopathic Gastroparesis in a Phase 3 Randomized Placebo-Controlled Clinical Trial. Clin Gastroenterol Hepatol. 2024 Dec;22(12):2506-2516. doi: 10.1016/j.cgh.2024.01.005. Epub 2024 Jan 17.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Study Website
Other Identifiers
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VP-VLY-686-3301
Identifier Type: -
Identifier Source: org_study_id
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