Effect of Tegaserod on Gastric Emptying in Patients With Diabetic Gastroparesis

An Open-label Pilot Trial to Assess the Effect of Tegaserod on Improvement of Gastric Emptying in Patients With Diabetic Gastroparesis and Upper Gastrointestinal Symptoms

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

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.