Effect of Tegaserod on Gastric Emptying in Patients With Diabetic Gastroparesis - Full Text View

Sponsored by:	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

MedlinePlus related topics: Diabetes Nausea and Vomiting

Drug Information available for: Tegaserod Tegaserod maleate

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
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

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

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

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

Keywords provided by Novartis:

Tegaserod
diabetes
diabetic gastroparesis

gastric emptying
gastric retention
electrogastrography

Study placed in the following topic categories:

Paralysis
Signs and Symptoms
Digestive System Diseases
Stomach Diseases
Gastrointestinal Diseases
Diabetes Mellitus

Neurologic Manifestations
Urinary Retention
Serotonin
Tegaserod
Gastroparesis

Additional relevant MeSH terms:

Serotonin Agonists
Neurotransmitter Agents
Serotonin Agents

Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009