Effect of Tegaserod on Orocecal Transit in Elderly Chronic Constipation Patients

March 2, 2016 updated by: Novartis

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • North Little Rock, Arizona, United States, 72117
        • Arkansas Gastroenterology, PA
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0362
        • University of Michigan Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Collaborators

University of Michigan
Temple University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

July 3, 2006

First Submitted That Met QC Criteria

July 3, 2006

First Posted (Estimate)

July 4, 2006

Study Record Updates

Last Update Posted (Estimate)

March 4, 2016

Last Update Submitted That Met QC Criteria

March 2, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHTF919EUS51

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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