Assessment of the Effect of Tegaserod (2 mg Tid and 6 mg Tid) on Dyspeptic Symptoms in Diabetic Patients With Symptoms of Diabetic Gastropathy

This study has been terminated.

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00142974

Purpose

This study is being done to evaluate the safety, tolerability and satisfactory relief of tegaserod against dyspeptic symptoms in diabetic patients with symptoms of diabetic gastropathy.

Condition	Intervention	Phase
Diabetic Gastropathy	Drug: Tegaserod	Phase II

MedlinePlus related topics: Nausea and Vomiting Stomach Disorders

Drug Information available for: Tegaserod Tegaserod maleate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Assessment of the Effect of Tegaserod (2 mg Tid and 6 mg Tid) on Dyspeptic Symptoms in Diabetic Patients With Symptoms of Diabetic Gastropathy

Further study details as provided by Novartis:

Primary Outcome Measures:

Reduction in weekly mean of a daily composite diabetic gastropathy dyspeptic symptom severity score throughout 6 weeks of treatment.

Secondary Outcome Measures:

Weekly global measure of dyspeptic symptom relief.
Weekly mean severity of individual dyspeptic symptoms (nausea, vomiting, retching, epigastric/stomach, discomfort/pain, postprandial fullness, bloating, early satiety).

Estimated Enrollment:	120
Study Start Date:	May 2004

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

History of Type 1 or insulin-requiring Type 2 diabetes for at least 3 years
GI symptoms for at least 2 months before entering study

Exclusion Criteria:

Very high body weight
Significant diarrhea
Ulcers

Symptom severity score collected via diary Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00142974

Locations

Switzerland
Novartis
Basel, Switzerland, 4056

Sponsors and Collaborators

Novartis

Investigators

Study Chair:	Novartis	Basel
Study Chair:	Novartis	Basel

More Information

Study ID Numbers:	CHTF919G2203
Study First Received:	August 31, 2005
Last Updated:	April 1, 2008
ClinicalTrials.gov Identifier:	NCT00142974
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Diabetes, tegaserod, gastropathy

Study placed in the following topic categories:

Digestive System Diseases
Stomach Diseases
Gastrointestinal Diseases

Diabetes Mellitus
Serotonin
Tegaserod

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 16, 2009