Effect of Tegaserod on Orocecal Transit in Elderly Chronic Constipation Patients

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Primary Purpose

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Tegaserod

About this trial

This is an interventional treatment trial for Chronic Constipation focused on measuring Constipation, Tegaserod, orocecal transit, colonic transit, gastric emptying

Eligibility Criteria

65 Years - undefined (Older Adult)All Sexes

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.

Sites / Locations

Arkansas Gastroenterology, PA
University of Michigan Medical Center
Temple University Hospital

Outcomes

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

Full Information

NCT ID

NCT00348634

First Posted

July 3, 2006

Last Updated

March 2, 2016

Sponsor

Novartis

Collaborators

Temple University, University of Michigan

1. Study Identification

Unique Protocol Identification Number

NCT00348634

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Terminated

Why Stopped

Terminated early due to regulatory action suspending tegaserod use in 2007

Study Start Date

July 2006 (undefined)

Primary Completion Date

April 2007 (Actual)

Study Completion Date

April 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis

Collaborators

Temple University, University of Michigan

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Constipation

Keywords

Constipation, Tegaserod, orocecal transit, colonic transit, gastric emptying

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Tegaserod

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Henry Parkman, MD

Organizational Affiliation

Temple

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

William Chey, MD

Organizational Affiliation

University of Michigan

Official's Role

Study Chair

Facility Information:

Facility Name

Arkansas Gastroenterology, PA

City

North Little Rock

State/Province

Arizona

ZIP/Postal Code

72117

Country

United States

Facility Name

University of Michigan Medical Center

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109-0362

Country

United States

Facility Name

Temple University Hospital

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19140

Country

United States

Chronic Constipation

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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