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

NCT ID: NCT00171431

Last Updated: 2012-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2006-05-31

Brief Summary

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

Detailed Description

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Conditions

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Constipation Predominant Irritable Bowel Syndrome (IBS-C)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Tegaserod

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis

Role: STUDY_DIRECTOR

Novartis

Locations

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Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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CHTF919AUS33

Identifier Type: -

Identifier Source: org_study_id

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