Overview

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