Study to Assess the Efficacy of VLY-686 in Relieving Symptoms of Gastroparesis

Completed · Phase 2 · Has a placebo group

Conditions studied: Gastroparesis

In brief

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.

Key facts

Study ID

NCT02970968

Run by

Vanda Pharmaceuticals

People needed

152

Starts

2016-11-01

Expected to finish

2018-12-01

Last updated by the study team

2024-08-06

Who can join

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

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.

Where it is running

• Vanda Investigational Site — Dothan, Alabama, United States
• Vanda Investigational Site — Huntsville, Alabama, United States
• Vanda Investigational Site — Tucson, Arizona, United States
• Vanda Investigational Site — Little Rock, Arkansas, United States
• Vanda Investigational Site — Chula Vista, California, United States
• Vanda Investigational Site — Los Angeles, California, United States
• Vanda Investigational Site — Palo Alto, California, United States
• Vanda Investigational Site — San Francisco, California, United States
• Vanda Investigational Site — Jacksonville, Florida, United States
• Vanda Investigational Site — Largo, Florida, United States
• Vanda Investigational Site — Miami, Florida, United States
• Vanda Investigational Site — Athens, Georgia, United States
• Vanda Investigational Site — Elgin, Illinois, United States
• Vanda Investigational Site — Indianapolis, Indiana, 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 — Wyoming, Michigan, United States
• Vanda Investigational Site — Minneapolis, Minnesota, United States
• Vanda Investigational Site — Pascagoula, Mississippi, United States
• Vanda Investigational Site — St Louis, Missouri, United States
• Vanda Investigational Site — Great Neck, New York, United States
• Vanda Investigational Site — New York, New York, United States

Full record on ClinicalTrials.gov

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