Study of Tadalafil for the Treatment of Diabetic Patients With Symptoms of Upset Stomach and Delayed Stomach Emptying
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...
Brief Summary
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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
Outcome Measures for this Clinical Trial
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
- 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
- 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
- Time Frame: 8 weeks
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: Eli Lilly and Company Industry
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
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00050609
