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...
Brief Summary
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: Tegaserod
Outcome Measures for this Clinical Trial
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
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: Novartis Industry
Overall Clinical Trial Officials and Contacts
Novartis Study Director Novartis
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00171431
