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

Eli Lilly and Company2 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Gastroparesis

Interventions

tadalafilDRUG

5 mg tadalafil tablet taken by mouth once a day for 8 weeks

tadalafilDRUG

20 mg tadalafil tablet taken by mouth once a day for 8 weeks

placeboDRUG

Placebo tablet taken by mouth once a day for 8 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 69 Years

Medical Language ↔ Plain English

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

Locations (12)

Outcomes

Primary Outcomes

Measure of change from baseline to endpoint using the Total Symptom Severity Score in patients taking 5 mg tadalafil compared to placebo

Time frame: 8 weeks

Secondary Outcomes

Measure of change from baseline to endpoint using the Total Symptom Severity Score in patients taking 20 mg tadalafil compared to placebo

Time frame: 8 weeks

Measure of change from baseline to endpoint using the Visual Analog Score and Nepean Dyspepsia Index Symptom Checklist in patients taking 5 mg tadalafil, 20 mg tadalafil and placebo

Time frame: 8 weeks

Data from ClinicalTrials.gov

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Edmonton, Alberta, Canada

Vancouver, British Columbia, Canada

Victoria, British Columbia, Canada

Winnipeg, Manitoba, Canada

Courtice, Ontario, Canada

Hamilton, Ontario, Canada

Kitchener, Ontario, Canada

London, Ontario, Canada

Ottawa, Ontario, Canada

Montreal, Quebec, Canada

...and 2 more locations