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

This study has been terminated.
(This study was terminated early in May 2006 due to low patient enrollment)
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00171431
First received: September 12, 2005
Last updated: April 19, 2012
Last verified: April 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Constipation Predominant
Irritable Bowel Syndrome (IBS-C)
 Drug: Tegaserod
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Effect of Tegaserod on Patterns of Flow in the Small Bowel of Patients With Irritable Bowel Syndrome (IBS)

Resource links provided by NLM:

MedlinePlus related topics: Constipation
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome 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

Estimated Enrollment: 20
Study Start Date: November 2004
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00171431

Locations
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Novartis
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00171431     History of Changes
Other Study ID Numbers: CHTF919AUS33
Study First Received: September 12, 2005
Last Updated: April 19, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
IBS-C
female

Additional relevant MeSH terms:
Constipation
Irritable Bowel Syndrome
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Tegaserod
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013