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

Phase 2

Completed

• Conditions: Gastroparesis
• Interventions: Drug: placebo; Drug: tadalafil

• Registration Number: NCT00050609
• Lead Sponsor: Eli Lilly and Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2002-12-16
• Study First Submitted QC: 2002-12-17
• Study First Posted: 2002-12-18
• Study Start: 2003-02
• Study Completion: 2003-09
• Status Verified: 2007-11
• Last Update Submitted: 2007-11-16
• Last Update Posted: 2007-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	placebo	-
2	tadalafil	5 mg tadalafil
3	tadalafil	20 mg tadalafil

Primary Outcome Measures

Name	Time	Method
Measure of change from baseline to endpoint using the Total Symptom Severity Score in patients taking 5 mg tadalafil compared to placebo	8 weeks

Secondary Outcome Measures

Name	Time	Method
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	8 weeks
Measure of change from baseline to endpoint using the Total Symptom Severity Score in patients taking 20 mg tadalafil compared to placebo	8 weeks

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.; 🇨🇦 Saskatoon, Saskatchewan, Canada