Effect of Tegaserod on Gastric Emptying in Patients With Diabetic Gastroparesis

Phase 4

Terminated

• Conditions: Gastroparesis; Diabetes

• Registration Number: NCT00390975
• Lead Sponsor: Novartis

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-10-20
• Study First Submitted QC: 2006-10-20
• Study First Posted: 2006-10-23
• Study Start: 2007-01
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-03
• Last Update Posted: 2012-05-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Electrogastrography (EGG)
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)
The safety and tolerability of tegaserod

Trial Locations

Locations (3)

The University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States

The University of Louisville; 🇺🇸 Louisville, Kentucky, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States