drugset

drugset / Trial / NCT04028492

Evaluating the Safety and Efficacy of Tradipitant vs. Placebo in Idiopathic and Diabetic Gastroparesis

NCT04028492 ↗

Phase 3 Completed 992 enrolled Vanda Pharmaceuticals

RandomizedParallel-groupQuadruple-blindTreatment

Summary

To investigate the safety and efficacy of tradipitant versus placebo in relieving nausea and other symptoms of gastroparesis.

Timeline

Start: 2019-08-20
Primary completion: 2025-02-21
Completion: 2025-02-21

Publications

Results Carlin JL, Polymeropoulos C, Camilleri M, Lembo A, Fisher M, Kupersmith C, Madonick D, Moszczynski P, Smieszek S, Xiao C, Birznieks G, Polymeropoulos MH. The Efficacy of Tradipitant in Patients With Diabetic and Idiopathic Gastroparesis in a Phase 3 Randomized Placebo-Controlled Clinical Trial. Clin Gastroenterol Hepatol. 2024 Dec;22(12):2506-2516. doi: 10.1016/j.cgh.2024.01.005. Epub 2024 Jan 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tradipitant	Small molecule	85 mg	Oral

Indications