Efficacy and Safety of Tradipitant in Patients With Diabetic and Idiopathic Gastroparesis in a Randomized, Placebo-Controlled Trial

Background & AimsTreatments are needed for gastroparesis; antagonists of tachykinin receptor 1 (TACR1, also called NK1R) can reduce symptoms nausea and vomiting. We investigated the safety efficacy tradipitant, an antagonist NK1R, in patients with idiopathic or diabetic gastroparesis.MethodsWe performed a double-blind trial 152 adults gastroparesis at 47 sites United States from November 2016 through December 2018. Participants were randomly assigned to groups given oral tradipitant 85 mg (n = 77) placebo 75) twice daily 4 weeks. Symptoms assessed by symptom dairy, Gastroparesis Cardinal Symptom Index scores, other patient-reported questionnaires. The primary outcome intent-to-treat analysis was change baseline week average severity, measured Core Daily Diary.ResultsPatients receiving had significant decrease score (reduction 1.2) compared 0.7) (P .0099) increase nausea-free days (28.8% on vs 15.0% placebo; P .0160). Patients vomiting 101) even greater when 1.4) those 0.4) < .0001), as well (32.3% improvement 7.6% .0003). less 32.9% 11.8% .0013). A than 1-point observed 46.6% 23.5% .0053).ConclusionsTradipitant resulted statistically clinically meaningful improvements reduced vomiting, placebo, gastroparesis. ClinicalTrials.gov, Number: NCT02970968 Treatments Diary. .0053). Tradipitant