NCT00050609

Study of Tadalafil for the Treatment of Diabetic Patients With Symptoms of Upset Stomach and Delayed Stomach Emptying

A Randomized, Double-Blind, Placebo-Controlled, Parallel Study of IC351 (LY450190) in Patients With Diabetic Gastroparesis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Not accepted

Summary

The purposes of this study are to determine whether an experimental drug known as tadalafil can reduce symptoms of dyspepsia (fullness after eating, inability to finish a regular meal, bloating, discomfort or pain in the upper abdomen, belching after meals, nausea, vomiting) in diabetic patients, and/or reduce the amount of time the stomach takes to empty the contents of a standard meal. The safety of tadalafil given once daily for 8 weeks in this population will also be studied.

Conditions

• Gastroparesis

Interventions

Type	Name	Description
DRUG	tadalafil	5 mg tadalafil tablet taken by mouth once a day for 8 weeks
DRUG	tadalafil	20 mg tadalafil tablet taken by mouth once a day for 8 weeks
DRUG	placebo	Placebo tablet taken by mouth once a day for 8 weeks

Timeline

• Start date: 2003-02-01
• Completion: 2003-09-01
• First posted: 2002-12-18
• Last updated: 2007-11-20

Locations

12 sites across 1 country: Canada