Effect of Tegaserod on Orocecal Transit in Elderly Chronic Constipation Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00348634
Recruitment Status : Terminated (Terminated early due to regulatory action suspending tegaserod use in 2007)
First Posted : July 4, 2006
Last Update Posted : March 4, 2016
Temple University
University of Michigan
Information provided by (Responsible Party):

Brief Summary:
This study will evaluate the effects of tegaserod on orocecal and colonic transit in patients over 65 years with chronic constipation.

Condition or disease Intervention/treatment Phase
Chronic Constipation Drug: Tegaserod Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Effects of Tegaserod on Orocecal Transit in Elderly Patients With Chronic Constipation
Study Start Date : July 2006
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Primary Outcome Measures :
  1. Orocecal transit: Time of radioactive marker to reach the cecum using scintigraphy

Secondary Outcome Measures :
  1. Whole gut transit and stomach emptying: Following 2 weeks of treatment, the rate of transit of food through the colon and stomach will be measured using scintigraphy

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Male & Females aged 65 and older
  • Patients must meet the criteria for chronic idiopathic constipation for at least 12 weeks
  • Patients must have had a colonoscopy within the past 5 years
  • Patients must pass a balloon expulsion test at screening
  • Patients must be able to comply and understand the use of a diary

Exclusion Criteria:

  • Patients with a clinically significant medical condition that would interfere with the patient completing the trial
  • Patients with loose stools at least once per week
  • Patients with IBS
  • Known allergies to the same class of drug and/or allergies to eggs
  • Patients who require the use of manual maneuvers to have a bowel movement

Other protocol-defined inclusion/exclusion criteria may apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00348634

United States, Arizona
Arkansas Gastroenterology, PA
North Little Rock, Arizona, United States, 72117
United States, Michigan
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109-0362
United States, Pennsylvania
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Temple University
University of Michigan
Study Chair: Henry Parkman, MD Temple
Study Chair: William Chey, MD University of Michigan

Responsible Party: Novartis Identifier: NCT00348634     History of Changes
Other Study ID Numbers: CHTF919EUS51
First Posted: July 4, 2006    Key Record Dates
Last Update Posted: March 4, 2016
Last Verified: March 2016

Keywords provided by Novartis:
Constipation, Tegaserod, orocecal transit, colonic transit, gastric emptying

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs