Evaluating the Safety and Efficacy of Tradipitant vs. Placebo in Idiopathic and Diabetic Gastroparesis

Completed · Phase 3 · Has a placebo group

Conditions studied: Idiopathic Gastroparesis, Diabetic Gastroparesis, Gastroparesis

In brief

To investigate the safety and efficacy of tradipitant versus placebo in relieving nausea and other symptoms of gastroparesis.

Key facts

Study ID

NCT04028492

Run by

Vanda Pharmaceuticals

People needed

992

Starts

2019-08-20

Expected to finish

2025-02-21

Last updated by the study team

2025-07-24

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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