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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

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

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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.

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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)
Volume and symptomatic response to a gastric satiety drink test (GSDT)
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
The safety and tolerability of tegaserod

Trial Locations

Locations (3)

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

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

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