Back to resultsEffect of Tegaserod on Gastric Emptying in Patients With Diabetic Gastroparesis
Primary Purpose
Gastroparesis, Diabetes
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tegaserod
Sponsored by
About this trial
This is an interventional treatment trial for Gastroparesis focused on measuring Tegaserod, diabetes, diabetic gastroparesis, gastric emptying, gastric retention, electrogastrography
Eligibility 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.
Sites / Locations
- The University of Kansas Medical Center
- The University of Louisville
- Beth Israel Deaconess Medical Center
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00390975
Brief Title
Effect of Tegaserod on Gastric Emptying in Patients With Diabetic Gastroparesis
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 Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Terminated
Why Stopped
This study was terminated early as a result of regulatory action suspending tegaserod use in 2007
Study Start Date
January 2007 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
This study will assess gastric emptying in patients with symptoms of diabetic gastroparesis treated with tegaserod over 2 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroparesis, Diabetes
Keywords
Tegaserod, diabetes, diabetic gastroparesis, gastric emptying, gastric retention, electrogastrography
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Tegaserod
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Change from baseline in patients treated with tegaserod relative to: The proportion of patients that normalize gastric emptying
Title
Symptoms of diabetic gastroparesis including postprandial fullness, early satiety, bloating, nausea and vomiting, and abdominal discomfort
Title
Volume and symptomatic response to a gastric satiety drink test (GSDT)
Title
Electrogastrography (EGG)
Title
The safety and tolerability of tegaserod
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceutical Corporation
Organizational Affiliation
NPC
Official's Role
Study Chair
Facility Information:
Facility Name
The University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
The University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40292
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Tegaserod on Gastric Emptying in Patients With Diabetic Gastroparesis
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