NCT01718938

Phase 2 Study of Velusetrag in Diabetic or Idiopathic Gastroparesis

A Multicenter, Double-Blind, Randomized, Placebo- Controlled, Phase 2 Study to Evaluate Velusetrag Effects on Gastric Emptying in Subjects With Diabetic or Idiopathic Gastroparesis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Theravance Biopharma · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, double-blind, incomplete block, three period fixed sequence crossover, multicenter, placebo-controlled study. The study will assess three oral doses of velusetrag (5 mg, 15 mg, and/or 30 mg) or placebo, administered once daily in three periods of 1-week duration each, with a 1-week washout period between treatment periods, in subjects with diabetic or idiopathic gastroparesis. Study 0093 will evaluate the effect of velusetrag in subjects with diabetic or idiopathic gastroparesis by assessing changes in gastric emptying.

Conditions

• Gastroparesis

Interventions

Type	Name	Description
DRUG	velusetrag dose 1
DRUG	velusetrag dose 2
DRUG	velusetrag dose 3
DRUG	placebo

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-12-01
• Completion: 2014-02-01
• First posted: 2012-11-01
• Last updated: 2018-02-26

Locations

9 sites across 1 country: United States