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

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Effect of Tegaserod on Orocecal Transit in Elderly Chronic Constipation Patients

This study has been terminated.

Study NCT00348634. Last updated on April 1, 2008. Information provided by Novartis

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Effect of Tegaserod on Orocecal Transit in Elderly Chronic Constipation Patients

Official Title ^†

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

Brief Summary

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

Detailed Description

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary Outcome Measure ^†

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

Secondary Outcome Measure ^†

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

Condition ^†

Chronic Constipation

Intervention ^†

Drug: Tegaserod

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Terminated

Enrollment ^†

Start Date ^†

July 2006

Completion Date

April 2007

Eligibility 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.

Gender

Both

Ages

65 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00348634

Organization ID

CHTF919EUS51

Secondary IDs ^††

Study Sponsor ^†

Novartis

Collaborators ^††

Temple University
University of Michigan

Investigators ^†

Study Chair:	Henry Parkman, MD	Temple
Study Chair:	William Chey, MD	University of Michigan

Information Provided By

Novartis

Verification Date

April 2008

First Received Date ^†

July 3, 2006

Last Updated Date

April 1, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.