Effect of Tegaserod on Gastric Emptying in Patients With Diabetic Gastroparesis

Stopped early · Phase 4

Conditions studied: Gastroparesis, Diabetes

In brief

This study will assess gastric emptying in patients with symptoms of diabetic gastroparesis treated with tegaserod over 2 weeks.

Key facts

Study ID

NCT00390975

Run by

Novartis

People needed

40

Starts

2007-01-01

Expected to finish

2007-03-01

Last updated by the study team

2012-05-04

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Females and males 18 to 75 years of age
• History of type I or type II diabetes mellitus for more than 3 years
• History of upper gastrointestinal symptoms consistent with diabetic gastroparesis
• Hemoglobin A1c < 9.5%
• Delayed gastric emptying

You may not qualify if…

• Abnormal endoscopy finding that can explain the presence of gastroparesis symptoms
• Medical conditions affecting gastric emptying
• A clinically significant medical condition that would interfere with the patient completing the trial
• Clinically significant abnormal creatinine level
• Known allergies to the same class of drug and/or allergies to eggs
• Severe obesity
• Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

• The University of Kansas Medical Center — Kansas City, Kansas, United States
• The University of Louisville — Louisville, Kentucky, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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