Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Vanda Pharmaceuticals

Stanford Investigator(s):

Intervention(s):

  • Drug: VLY-686 (Tradipitant)
  • Other: Placebo

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   1. Diagnosed with gastroparesis;

   2. Subjects must agree to the use of contraception

   3. Ability and acceptance to provide written informed consent;

   4. Willing to participate in the pharmacogenomics sample collection;

   5. Willing and able to comply with all study requirements and restrictions

   6. 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 palonosetronÍž

   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.

Ages Eligible for Study

18 Years - 70 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Emerald Poon Adler
6507212665
Not Recruiting