Effect of Tegaserod on Orocecal Transit in Elderly Chronic Constipation Patients - Full Text View

Effect of Tegaserod on Orocecal Transit in Elderly Chronic Constipation Patients

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

Sponsors and Collaborators:	Novartis Temple University University of Michigan
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00348634

Purpose

This study will evaluate the effects of tegaserod on orocecal and colonic transit in patients over 65 years with chronic constipation.

Condition	Intervention	Phase
Chronic Constipation	Drug: Tegaserod	Phase IV

MedlinePlus related topics:

Constipation

ChemIDplus related topics:

Tegaserod Tegaserod maleate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Official Title:	The Effects of Tegaserod on Orocecal Transit in Elderly Patients With Chronic Constipation

Further study details as provided by Novartis:

Primary Outcome Measures:

Orocecal transit: Time of radioactive marker to reach the cecum using scintigraphy

Secondary Outcome Measures:

Whole gut transit and stomach emptying: Following 2 weeks of treatment, the rate of transit of food through the colon and stomach will be measured using scintigraphy

Estimated Enrollment:	60
Study Start Date:	July 2006
Study Completion Date:	April 2007

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Male & Females aged 65 and older
Patients must meet the criteria for chronic idiopathic constipation for at least 12 weeks
Patients must have had a colonoscopy within the past 5 years
Patients must pass a balloon expulsion test at screening
Patients must be able to comply and understand the use of a diary

Exclusion Criteria:

Patients with a clinically significant medical condition that would interfere with the patient completing the trial
Patients with loose stools at least once per week
Patients with IBS
Known allergies to the same class of drug and/or allergies to eggs
Patients who require the use of manual maneuvers to have a bowel movement

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00348634

Locations


United States, Arizona
	Arkansas Gastroenterology, PA
	North Little Rock, Arizona, United States, 72117

United States, Michigan
	University of Michigan Medical Center
	Ann Arbor, Michigan, United States, 48109-0362

United States, Pennsylvania
	Temple University Hospital
	Philadelphia, Pennsylvania, United States, 19140

Sponsors and Collaborators

Novartis

Temple University

University of Michigan

Investigators


Study Chair:	Henry Parkman, MD	Temple

Study Chair:	William Chey, MD	University of Michigan

More Information

Study ID Numbers:	CHTF919EUS51
First Received:	July 3, 2006
Last Updated:	April 1, 2008
ClinicalTrials.gov Identifier:	NCT00348634
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Constipation, Tegaserod, orocecal transit, colonic transit, gastric emptying

Study placed in the following topic categories:

Signs and Symptoms

Signs and Symptoms, Digestive

Constipation

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 September 05, 2008