Effect of Tegaserod on Gastric Emptying in Patients With Diabetic Gastroparesis

This study has been terminated.

( This study was terminated early as a result of regulatory action suspending tegaserod use in 2007 )

First Received on October 20, 2006. Last Updated on March 31, 2008 History of Changes

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00390975

Purpose

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

Condition	Intervention	Phase
Gastroparesis Diabetes	Drug: Tegaserod	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Nausea and Vomiting

Drug Information available for: Tegaserod Tegaserod maleate

U.S. FDA Resources

Further study details as provided by Novartis:

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

Estimated Enrollment:	40
Study Start Date:	January 2007

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00390975

Locations

United States, Kansas
The University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Kentucky
The University of Louisville
Louisville, Kentucky, United States, 40292
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis Pharmaceutical Corporation

NPC

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00390975 History of Changes
Other Study ID Numbers:	CHTF919GUS62
Study First Received:	October 20, 2006
Last Updated:	March 31, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Tegaserod
diabetes
diabetic gastroparesis

gastric emptying
gastric retention
electrogastrography

Additional relevant MeSH terms:

Diabetes Mellitus
Gastroparesis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis

Neurologic Manifestations
Signs and Symptoms
Tegaserod
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 12, 2012