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

• Status: Completed
• Trial end date: 2003-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Collaborator: ICOS Corporation
• Treatments: Tadalafil

Criteria

Inclusion Criteria:

• Diagnosis of diabetes mellitus

• Delayed gastric emptying

• 3 month minimum history of chronic upper abdominal discomfort

• Symptoms of dyspepsia (upset stomach)

Exclusion Criteria:

• Major gastrointestinal surgery or medical conditions known to affect gastric motility

• Irritable Bowl Syndrome

• Medications known to affect gastric motility

• Angina treated with nitrates

• Uncontrolled diabetes mellitus and history of certain heart problems