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

Phase 3

Terminated

• Conditions: Constipation Predominant; Irritable Bowel Syndrome (IBS-C)

• Registration Number: NCT00171431
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-15
• Primary Completion: 2006-05
• Study Completion: 2006-05
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-19
• Last Update Posted: 2012-04-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States