What the trial was testing
The trial enrolled 152 patients with gastroparesis. The study was sponsored by Vanda Pharmaceuticals and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was mid-stage testing (phase 2/3). Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
Patients taking tradipitant had nearly twice as many nausea-free days compared to placebo after 4 weeks.
Gastroenterology · 2021 · NCT02970968
These findings — that patients on tradipitant had nearly double the improvement in nausea-free days versus placebo — were published in the Gastroenterology and represent the headline result of the study.
Researchers tracked outcomes across 152 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with gastroparesis, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
This was a mid-stage study and tradipitant is not yet FDA-approved for gastroparesis. The results showed meaningful improvement in nausea symptoms. If you have gastroparesis, ask your doctor about open trials testing tradipitant or other treatment options that may help manage your symptoms.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open gastroparesis trials
Vagal Nerve Stimulation for Functional Dyspepsia and Gastroparesis
Explore the effects of auricular transcutaneous vagal nerve stimulation (taVNS) on brain and stomach outcomes in functional dyspepsia and gastroparesis patients.
Indiana University Gastrointestinal Motility Diagnosis Registry
Develop a registry (list of patients) with accurate clinical motility diagnosis. This registry will help the doctors to identify the patients with specific disease conditions. It will also help in promoting future research in gastroenterology motility disorders