Effect of Tegaserod on Gastric Emptying in Patients With Diabetic Gastroparesis

• Status: Terminated
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Tegaserod

Criteria

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.