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Evaluating Tradipitant for Nausea Relief in Gastroparesis

VP-VLY-686-3301: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase Iii Study To Assess The Efficacy Of Tradipitant In Relieving Symptoms Of Gastroparesis

Phase 3 Interventional Vanda Pharmaceuticals · NCT04028492

This study is testing if a new medication called tradipitant can help people with gastroparesis feel less nauseous compared to a placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment201 (estimated)
Ages18 Years to 70 Years
SexAll
SponsorVanda Pharmaceuticals Industry-sponsored
Locations36 sites (Birmingham, Alabama and 35 other locations)
Trial IDNCT04028492 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and efficacy of tradipitant, a medication, compared to a placebo in patients suffering from idiopathic and diabetic gastroparesis. The study focuses on alleviating nausea and other related symptoms associated with delayed gastric emptying. Participants will be monitored for their response to the treatment over the course of the trial. The study aims to provide insights into the effectiveness of tradipitant in managing this condition.

Who should consider this trial

Good fit: Ideal candidates for this study are adults diagnosed with gastroparesis who experience moderate to severe nausea and have a BMI between 18 and 40 kg/m2.

Not a fit: Patients with other active disorders that could explain their symptoms or those who have undergone certain surgical procedures related to the stomach may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from gastroparesis by reducing nausea and other debilitating symptoms.

How similar studies have performed: While this approach is focused on tradipitant, similar studies targeting nausea relief in gastroparesis have shown promise, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Diagnosed with gastroparesis
* Demonstrated delayed gastric emptying
* Presence of moderate to severe nausea
* Body Mass Index (BMI) of ≥18 and ≤40 kg/m2

Exclusion Criteria:

* 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 this trial is running

Birmingham, Alabama and 35 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Idiopathic GastroparesisDiabetic GastroparesisGastroparesisgastroparesisidiopathicdiabetictradipitantnausea
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.