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

Tracking Information

First Received Date ^ICMJE

July 3, 2006

Last Updated Date

April 1, 2008

Start Date ^ICMJE

July 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00348634 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Effect of Tegaserod on Orocecal Transit in Elderly Chronic Constipation Patients

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Chronic Constipation

Intervention ^ICMJE

Drug: Tegaserod

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

Completion Date

April 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00348634

Responsible Party

Study ID Numbers ^ICMJE

CHTF919EUS51

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Temple University
University of Michigan

Investigators ^ICMJE

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

Information Provided By

Novartis

Verification Date

April 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP