NCT03281577

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

A Dose-Ranging, Randomized, Parallel, Placebo-Controlled Study to Assess the Effect of TAK-954 on Gastrointestinal and Colonic Transit in Patients With Diabetic or Idiopathic Gastroparesis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The drug being tested in this study is called TAK-954. TAK-954 is a serotonin (5 HT4) receptor agonist and is being tested to treat people who have diabetic or idiopathic gastroparesis and who previously reported delay in stomach emptying. This study will look at the gastric emptying time of solids in people who take TAK-954 or placebo. The study will enroll approximately 41 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the four treatment groups-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need): * TAK-954 0.1 mg * TAK-954 0.3 mg * TAK-954 1 mg * Placebo (dummy inactive solution) - this is a solution that looks like the study drug but has no active ingredient. This single center trial will be conducted in the United States. The duration of treatment is 3 days and the overall period of evaluation is up to 28 days. The participants will be contacted by telephone (Days 10 to 14) for follow-up assessment. There will be another follow-up phone call for women of childbearing potential (Days 38 to 43).

Conditions

• Diabetic Gastroparesis
• Idiopathic Gastroparesis

Interventions

Type	Name	Description
DRUG	TAK-954	TAK-954 IV infusion.
DRUG	Placebo	TAK-954 placebo-matching IV infusion.

Timeline

• Start date: 2018-01-02
• Primary completion: 2019-06-07
• Completion: 2019-07-12
• First posted: 2017-09-13
• Last updated: 2021-01-07
• Results posted: 2020-07-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study