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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Terminated

CT.gov ID

NCT00171431

Collaborator

(none)

Enrollment

Location

17.9

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Constipation Predominant Irritable Bowel Syndrome (IBS-C)	Drug: Tegaserod	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2004

Actual Primary Completion Date :

May 1, 2006

Actual Study Completion Date :

May 1, 2006

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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.