Effect of Tegaserod on Gastric Emptying in Patients With Diabetic Gastroparesis

Sponsor

Novartis (Industry)

Overall Status

Terminated

CT.gov ID

NCT00390975

Collaborator

(none)

Enrollment

Locations

1.9

Duration (Months)

13.3

Patients Per Site

6.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Gastroparesis Diabetes	Drug: Tegaserod	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2007

Actual Primary Completion Date :

Mar 1, 2007

Actual Study Completion Date :

Mar 1, 2007

Outcome Measures

Primary Outcome Measures

Proportion of patients treated with tegaserod that improve gastric emptying at Week 2 as compared with baseline via a solid phase technetium gastric emptying time (GET) []

Secondary Outcome Measures

Change from baseline in patients treated with tegaserod relative to: The proportion of patients that normalize gastric emptying []
Symptoms of diabetic gastroparesis including postprandial fullness, early satiety, bloating, nausea and vomiting, and abdominal discomfort []
Volume and symptomatic response to a gastric satiety drink test (GSDT) []
Electrogastrography (EGG) []
The safety and tolerability of tegaserod []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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