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
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
The Coordination of Rare Diseases at Sanford (CoRDS) is an international patient registry that serves as a centralized resource for rare disease research. Individuals affected by rare diseases, undiagnosed conditions, and disorders of unknown prevalence may voluntarily contribute health information to support natural history studies, participant recruitment, and other research efforts. Through partnerships with patient advocacy organizations and researchers worldwide, CoRDS helps connect rare disease communities with research opportunities while advancing knowledge across more than 7,000 rare diseases. Participation is free of charge.
Prokinetics and Body Surface Gastric Mapping in Dyspeptic Patients: Baseline and Treatment Effects
Functional dyspepsia and gastroparesis are common stomach disorders with symptoms like early satiety, nausea, and abdominal pain, and are often evaluated with gastric emptying tests, although the correlation with symptoms is weak. Prokinetic agents (e.g., metoclopramide, erythromycin) and symptom modulators (e.g., nortriptyline, mirtazapine) are commonly used, but selecting the right medication can be difficult, as it's often based on symptoms rather than the underlying gastric issues. Body Surface Gastric Mapping (BSGM) using the Gastric Alimetry device is a novel, non-invasive tool to assess gastric myoelectrical activity and symptoms. This study aims to perform two BSGM recordings-one before and one after medical therapy-to understand how medications affect gastric function and identify baseline BSGM factors that could predict responses to treatment, potentially guiding tailored therapies based on individual gastric dysfunction.