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The Effect of Tegaserod on Patterns of Flow in the Small Bowel of Patients With Irritable Bowel Syndrome (IBS)

Primary Purpose

Constipation Predominant, Irritable Bowel Syndrome (IBS-C)

Status

Terminated

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Tegaserod

About this trial

This is an interventional treatment trial for Constipation Predominant focused on measuring IBS-C, female

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Female 18 and older IBS-C patients diagnosed on the basis of Rome II criteria Ability to comply with the requirements of the entire study Exclusion Criteria: Evidence of structural abnormality of the gastrointestinal tract or disease/conditions. Patients with previous gastrointestinal surgery other than appendectomy or cholecystectomy. Evidence of cathartic colon or a history of laxative use, that in the investigator's opinion is consistent with severe laxative dependence such that the patient is likely to require or use laxatives during the study Other protocol-defined inclusion/exclusion criteria may apply.

Sites / Locations

Cedars-Sinai Medical Center

Outcomes

Primary Outcome Measures

To evaluate the effects of tegaserod on motility and small intestinal flow patterns after meal in female patients with IBS-C

by using Multiple Intraluminal Impedance

Secondary Outcome Measures

Full Information

NCT ID

NCT00171431

First Posted

September 12, 2005

Last Updated

April 19, 2012

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00171431

Brief Title

The Effect of Tegaserod on Patterns of Flow in the Small Bowel of Patients With Irritable Bowel Syndrome (IBS)

Official Title

The Effect of Tegaserod on Patterns of Flow in the Small Bowel of Patients With Irritable Bowel Syndrome (IBS)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2012

Overall Recruitment Status

Terminated

Why Stopped

This study was terminated early in May 2006 due to low patient enrollment

Study Start Date

November 2004 (undefined)

Primary Completion Date

May 2006 (Actual)

Study Completion Date

May 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

Evaluation of the effect of tegaserod treatment on small intestinal motility and flow pattern in female IBS-C patients.

6. Conditions and Keywords

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

Constipation Predominant, Irritable Bowel Syndrome (IBS-C)

Keywords

IBS-C, female

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

20 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Tegaserod

Primary Outcome Measure Information:

Title

To evaluate the effects of tegaserod on motility and small intestinal flow patterns after meal in female patients with IBS-C

Title

by using Multiple Intraluminal Impedance

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis

Organizational Affiliation

Novartis

Official's Role

Study Director

Facility Information:

Facility Name

Cedars-Sinai Medical Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

12. IPD Sharing Statement

Learn more about this trial

The Effect of Tegaserod on Patterns of Flow in the Small Bowel of Patients With Irritable Bowel Syndrome (IBS)

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