Status:
TERMINATED
Effect of Tegaserod on Gastric Emptying in Patients With Diabetic Gastroparesis
Lead Sponsor:
Novartis
Conditions:
Gastroparesis
Diabetes
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
This study will assess gastric emptying in patients with symptoms of diabetic gastroparesis treated with tegaserod over 2 weeks.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00390975
Start Date
January 1 2007
End Date
March 1 2007
Last Update
May 4 2012
Active Locations (3)
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1
The University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
2
The University of Louisville
Louisville, Kentucky, United States, 40292
3
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215