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

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanda Pharmaceuticals

Criteria

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 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.