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 )

First Received: July 3, 2006 Last Updated: April 1, 2008 History of Changes

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

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

Resource links provided by NLM:

MedlinePlus related topics: Constipation

Drug Information available for: Tegaserod Tegaserod maleate

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

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

No publications provided

Study ID Numbers:	CHTF919EUS51
Study First Received:	July 3, 2006
Last Updated:	April 1, 2008
ClinicalTrials.gov Identifier:	NCT00348634 History of Changes
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:

Serotonin Agonists
Signs and Symptoms
Neurotransmitter Agents
Signs and Symptoms, Digestive

Constipation
Serotonin
Tegaserod

Additional relevant MeSH terms:

Serotonin Agonists
Signs and Symptoms
Neurotransmitter Agents
Serotonin Agents
Molecular Mechanisms of Pharmacological Action

Signs and Symptoms, Digestive
Physiological Effects of Drugs
Constipation
Pharmacologic Actions
Tegaserod

ClinicalTrials.gov processed this record on September 11, 2009