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

Novartis

Status and phase: Terminated; Phase 3

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

Treatments: Drug: Tegaserod

Study type: Interventional

Funder types: Industry

Identifiers

NCT00171431

CHTF919AUS33

Details and patient eligibility

About

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

Sex: Female

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind