Evaluating the Safety and Efficacy of Tradipitant vs. Placebo in Idiopathic and Diabetic Gastroparesis
VP-VLY-686-3301: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase Iii Study To Assess The Efficacy Of Tradipitant In Relieving Symptoms Of Gastroparesis
1 other identifier
interventional
992
1 country
36
Brief Summary
To investigate the safety and efficacy of tradipitant versus placebo in relieving nausea and other symptoms of gastroparesis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2019
Longer than P75 for phase_3
36 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
First Submitted
Initial submission to the registry
July 10, 2019
CompletedFirst Posted
Study publicly available on registry
July 22, 2019
CompletedStudy Start
First participant enrolled
August 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 21, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 21, 2025
CompletedJuly 24, 2025
February 1, 2025
5.5 years
July 10, 2019
July 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in daily average nausea severity scores from the Gastroparesis Core Symptom Daily Diary (GCS-DD)
A daily symptom diary asking patients to rate their nausea on a Likert scale from 0-5 (0=none, 5= very severe).
12 weeks
Secondary Outcomes (5)
Change from baseline in other average core gastroparesis symptoms from the Gastroparesis Core Symptom Daily Diary
12 weeks
Change from baseline in Patient Assessment of Gastrointestinal Disorders - Symptoms Severity Index (PAGI-SYM)
12 weeks
Change from baseline in Patient Global Impression - Change (PGI-C)
12 weeks
Clinician Global Impression - Severity (CGI-S)
12 weeks
Safety and tolerability as measured by spontaneous reporting of adverse events (AEs)
12 weeks
Study Arms (3)
Tradipitant
EXPERIMENTALOral Capsule
Placebo
PLACEBO COMPARATOROral Capsule
Open Label Tradipitant
EXPERIMENTALOral Capsule
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosed with gastroparesis
- Demonstrated delayed gastric emptying
- Presence of moderate to severe nausea
- Body Mass Index (BMI) of ≥18 and ≤40 kg/m2
You may not qualify if:
- Another active disorder or treatment which could explain or contribute to symptoms of gastroparesis
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Vanda Investigational Site
Birmingham, Alabama, 53244, United States
Vanda Investigational Site
Peoria, Arizona, 85381, United States
Vanda Investigational Site
Little Rock, Arkansas, 72211, United States
Vanda Investigational Site
Chula Vista, California, 91910, United States
Vanda Investigational Site
La Jolla, California, 92093, United States
Vanda Investigational Site
Los Angeles, California, 90010, United States
Vanda Investigational Site
Los Angeles, California, 90026, United States
Vanda Investigational Site
Maitland, Florida, 32751, United States
Vanda Investigational Site
Palmetto Bay, Florida, 33157, United States
Vanda Investigational Site
Tampa, Florida, 33613, United States
Vanda Investigational Site
Morrow, Georgia, 30260, United States
Vanda Investigational Site
Wauconda, Illinois, 60084, United States
Vanda Investigational Site
West Des Moines, Iowa, 50265, United States
Vanda Investigational Site
Wichita, Kansas, 67214, 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, 02115, United States
Vanda Investigational Site
Chesterfield, Missouri, 63005, United States
Vanda Investigational Site
Las Vegas, Nevada, 89121, United States
Vanda Investigational Site
Brooklyn, New York, 11201, United States
Vanda Investigational Site
Charlotte, North Carolina, 28209, United States
Vanda Investigational Site
Raleigh, North Carolina, 27612, United States
Vanda Investigational Site
Columbus, Ohio, 43214, United States
Vanda Investigational Site
Huber Heights, Ohio, 45424, United States
Vanda Investigational Site
Edmond, Oklahoma, 73034, United States
Vanda Investigational Site
Tulsa, Oklahoma, 74104, United States
Vanda Investigational Site
Philadelphia, Pennsylvania, 19104, United States
Vanda Investigational Site
Chattanooga, Tennessee, 37421, United States
Vanda Investigational Site
Nashville, Tennessee, 37211, United States
Vanda Investigational Site
Houston, Texas, 77043, United States
Vanda Investigational Site
Houston, Texas, 77084, United States
Vanda Investigational Site
Plano, Texas, 75024, United States
Vanda Investigational Site
San Antonio, Texas, 78215, United States
Vanda Investigational Site
Salt Lake City, Utah, 84132, United States
Related Publications (1)
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.
PMID: 38237696RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Vanda Pharmaceuticals
Vanda Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2019
First Posted
July 22, 2019
Study Start
August 20, 2019
Primary Completion
February 21, 2025
Study Completion
February 21, 2025
Last Updated
July 24, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share