Tradipitant shows therapeutic potential in patients with gastroparesis
Treatment with tradipitant in patients with idiopathic or diabetic gastroparesis produces meaningful improvements in nausea and vomiting, according to the results of a phase II trial.
In total, 152 adult patients were randomized to receive oral tradipitant (85 mg; n=77) or placebo (n=75) twice daily for 4 weeks. Researchers assessed symptoms using a daily symptom dairy, gastroparesis cardinal symptom index scores, and other patient-reported questionnaires.
At baseline, nausea severity score was moderate to severe at 3.21, and the percentage of nausea-free days was 7.56 percent. Average scores of other core gastroparesis symptoms were moderate to severe in degree, although not every patient presented with all symptoms.
Four weeks of tradipitant vs placebo led to a significant reduction in average nausea severity (–1.2 vs –0.7; p=0.0099) and an increase in nausea-free days (28.8 percent vs 15.0 percent; p=0.0160). The effects were greater among patients with nausea and vomiting at baseline (n=101; nausea severity: p<0.0001; nausea-free days; p=0.0003).
Average nausea score was ≤1 at week 4 in 32.9 percent of patients in the tradipitant group as opposed to 11.8 percent of those in the placebo group (p=0.0013). Finally, 46.6 percent and 23.5 percent of patients in the respective groups achieved >1-point improvement in gastroparesis cardinal symptom index score (p=0.0053).
Tradipitant was well tolerated, with an adverse event profile similar to placebo.
According to the researchers, the benefits conferred by tradipitant for nausea and overall symptoms may be indicative of a disease-modifying effect through an action to the local neuromuscular network, as well as the central nervous system centres for nausea and vomiting.