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

Lilly

Status and phase: Completed; Phase 2

Conditions: Gastroparesis

Treatments: Drug: tadalafil; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00050609

H6D-MC-LVDC

4979

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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2 participants in 3 patient groups, including a placebo group

1

Placebo Comparator group

Treatment:

Drug: placebo

2

Active Comparator group

Description:

5 mg tadalafil

Treatment:

Drug: tadalafil

Drug: tadalafil

3

Active Comparator group

Description:

20 mg tadalafil

Treatment:

Drug: tadalafil

Drug: tadalafil