Effect of Tegaserod on Orocecal Transit in Elderly Chronic Constipation Patients

NCT ID: NCT00348634

Last Updated: 2016-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2007-04-30

Brief Summary

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

Detailed Description

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Conditions

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Chronic Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Tegaserod

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Temple University

OTHER

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role collaborator

Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Henry Parkman, MD

Role: STUDY_CHAIR

Temple

William Chey, MD

Role: STUDY_CHAIR

University of Michigan

Locations

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Arkansas Gastroenterology, PA

North Little Rock, Arizona, United States

Site Status

University of Michigan Medical Center

Ann Arbor, Michigan, United States

Site Status

Temple University Hospital

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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CHTF919EUS51

Identifier Type: -

Identifier Source: org_study_id

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