Official Title: “The Effect of Tegaserod on Patterns of Flow in the Small Bowel of Patients With Irritable Bowel Syndrome (IBS)”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Tegaserod

Primary 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

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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Study Director Novartis  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00171431

Study ID Number: CHTF919AUS33

ClinicalTrials.gov Identifier: NCT00171431

Health Authority: United States: Food and Drug Administration