Official Title: “A Randomized, Double-Blind, Placebo-Controlled, Parallel Study of IC351 (LY450190) in Patients With Diabetic Gastroparesis”

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

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: tadalafil
  • 5 mg tadalafil tablet taken by mouth once a day for 8 weeks
• Drug: tadalafil
  • 20 mg tadalafil tablet taken by mouth once a day for 8 weeks
• Drug: placebo
  • Placebo tablet taken by mouth once a day for 8 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: 1
• Active Comparator: 2
  • 5 mg tadalafil
• Active Comparator: 3
  • 20 mg tadalafil

Primary Measures

• 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 Measures

• 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
    

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 69 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Eli Lilly and Company

Overall Clinical Trial Officials and Contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Study Director Eli Lilly and Company  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00050609

Study ID Number: 4979

ClinicalTrials.gov Identifier: NCT00050609

Health Authority: United States: Food and Drug Administration

Lilly Clinical Trial Registry