Effect of TAK-954 on Gastrointestinal and Colonic Transit in Diabetic or Idiopathic Gastroparesis Participants

Summary

The purpose of this study is to evaluate the dose-dependent effects of TAK-954 on gastric emptying time of solids in participants with diabetic or idiopathic gastroparesis assessed by scintigraphy.

Timeline

Start

2018-01-02

Primary completion

2019-06-07

Completion

2019-07-12

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs TAK-954 0.1 mg; p = 0.0012; Least Squares Mean Differences -25.81 (95% CI -41.757 to -9.858); NCT03281577 ↗

registry analysis (superiority test); Placebo vs TAK-954 0.3 mg; p = 0.0018; Least Squares Mean Differences -27.52 (95% CI -45.224 to -9.813); NCT03281577 ↗

registry analysis (superiority test); Placebo vs TAK-954 1 mg; p <.0001; Least Squares Mean Differences -41.76 (95% CI -59.616 to -23.902); NCT03281577 ↗

Publications

• Chedid V, Brandler J, Arndt K, Vijayvargiya P, Wang XJ, Burton D, Harmsen WS, Siegelman J, Chen C, Chen Y, Almansa C, Dukes G, Camilleri M. Randomised study: effects of the 5-HT4 receptor agonist felcisetrag vs placebo on gut transit in patients with gastroparesis. Aliment Pharmacol Ther. 2021 May;53(9):1010-1020. doi: 10.1111/apt.16304. Epub 2021 Mar 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	felcisetrag	Small molecule	0.1 mg	Intravenous
Subject	felcisetrag	Small molecule	0.3 mg	Intravenous
Subject	felcisetrag	Small molecule	1 mg	Intravenous

Indications