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

Tracking Information

First Received Date ^ICMJE

December 16, 2002

Last Updated Date

November 16, 2007

Start Date ^ICMJE

February 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00050609 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Gastroparesis

Intervention ^ICMJE

Drug: tadalafil
Drug: placebo

Study Arms / Comparison Groups

Active Comparator: 5 mg tadalafil
Active Comparator: 20 mg tadalafil

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2003

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years to 69 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT ID ^ICMJE

NCT00050609

Responsible Party

Study ID Numbers ^ICMJE

4979, H6D-MC-LVDC

Study Sponsor ^ICMJE

Eli Lilly and Company

Collaborators ^ICMJE

ICOS Corporation

Investigators ^ICMJE

Study Director:

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)

Eli Lilly and Company

Information Provided By

Eli Lilly and Company

Verification Date

November 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP