Text Size

Effect of Tegaserod on Orocecal Transit in Elderly Chronic Constipation Patients

This study has been terminated.
(This study was terminated early as a result of regulatory action suspending tegaserod use in 2007)
Sponsor:
Collaborators:
Temple University
University of Michigan
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00348634
First received: July 3, 2006
Last updated: April 1, 2008
Last verified: April 2008
History of Changes
  Purpose

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


Condition Intervention Phase
Chronic Constipation
 Drug: Tegaserod
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Effects of Tegaserod on Orocecal Transit in Elderly Patients With Chronic Constipation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 60
Study Start Date: July 2006
Study Completion Date: April 2007
  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00348634

Locations
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
Novartis
Temple University
University of Michigan
Investigators
Study Chair: Henry Parkman, MD Temple
Study Chair: William Chey, MD University of Michigan
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00348634     History of Changes
Other Study ID Numbers: CHTF919EUS51
Study First Received: July 3, 2006
Last Updated: April 1, 2008
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
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 19, 2013