Gastroparesis

A clinical trial for individuals suffering from gastroparesis is now open to enrollment.

About the research trial (also viewable on clinicaltrials.gov):

This is a multicenter, randomized, double-blind, placebo-controlled study. The study is divided into two phases: the screening phase and the evaluation phase. The screening phase includes a screening visit to evaluate subjects’ preliminary eligibility for the study. During the screening phase, subjects will collect diary data for at least 4 weeks. The evaluation phase includes 4 weeks of randomized double-blind treatment.

Basic Inclusion Criteria:

  1. Diagnosed with gastroparesis;
  2. Subjects 18 to 70 years of age
  3. Subjects must agree to the use of contraception
  4. Ability and acceptance to provide written informed consent;
  5. Willing to participate in the pharmacogenomics sample collection;
  6. Willing and able to comply with all study requirements and restrictions
  7. Willing to not participate in any other interventional trial for the duration of their participation.

Exclusion Criteria:

  1. 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);
  2. Pregnancy or nursing;
  3. History of intolerance and/or hypersensitivity to medications similar to VLY-686 (Tradipitant) and its accompanying excipients;
  4. Use of another NK1 antagonist or palonosetron;
  5. Exposure to any investigational medication, including placebo, within 60 days of the Baseline Visit;
  6. 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.

 

If you are interested in participating or if you would like to learn more, please get in contact with our Research Team at 616-328-5344.