Overview

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.