- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00171431
The Effect of Tegaserod on Patterns of Flow in the Small Bowel of Patients With Irritable Bowel Syndrome (IBS)
April 19, 2012 updated by: Novartis Pharmaceuticals
Evaluation of the effect of tegaserod treatment on small intestinal motility and flow pattern in female IBS-C patients.
Study Overview
Status
Terminated
Intervention / Treatment
Study Type
Interventional
Enrollment
20
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Los Angeles, California, United States, 90048
- Cedars-Sinai Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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To evaluate the effects of tegaserod on motility and small intestinal flow patterns after meal in female patients with IBS-C
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by using Multiple Intraluminal Impedance
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2004
Primary Completion (Actual)
May 1, 2006
Study Completion (Actual)
May 1, 2006
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 15, 2005
Study Record Updates
Last Update Posted (Estimate)
April 20, 2012
Last Update Submitted That Met QC Criteria
April 19, 2012
Last Verified
April 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Disease
- Signs and Symptoms, Digestive
- Gastrointestinal Diseases
- Colonic Diseases, Functional
- Colonic Diseases
- Intestinal Diseases
- Syndrome
- Irritable Bowel Syndrome
- Constipation
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Serotonin Agents
- Serotonin Receptor Agonists
- Tegaserod
Other Study ID Numbers
- CHTF919AUS33
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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NovartisCompleted
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NovartisCompletedDyspepsiaUnited States
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NovartisCompleted
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NovartisCompletedGastroesophageal Reflux Disease (GERD)United States
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NovartisCompletedIBS-C and IBS With Mixed Bowel Habits
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NovartisTerminatedDiabetes | GastroparesisUnited States
-
NovartisCompletedChronic ConstipationSwitzerland