Constipation Predominant Clinical Trial
Official title:
The Effect of Tegaserod on Patterns of Flow in the Small Bowel of Patients With Irritable Bowel Syndrome (IBS)
| Verified date | April 2012 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
Evaluation of the effect of tegaserod treatment on small intestinal motility and flow pattern in female IBS-C patients.
| Status | Terminated |
| Enrollment | 20 |
| Est. completion date | May 2006 |
| Est. primary completion date | May 2006 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Cedars-Sinai Medical Center | Los Angeles | California |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To evaluate the effects of tegaserod on motility and small intestinal flow patterns after meal in female patients with IBS-C | |||
| Primary | by using Multiple Intraluminal Impedance |