Effect of Tegaserod on Orocecal Transit in Elderly Chronic Constipation Patients
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Constipation
Intervention: Tegaserod (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Henry Parkman, MD, Study Chair, Affiliation: Temple
William Chey, MD, Study Chair, Affiliation: University of Michigan
Summary
This study will evaluate the effects of tegaserod on orocecal and colonic transit in patients
over 65 years with chronic constipation.
Clinical Details
Official title: The Effects of Tegaserod on Orocecal Transit in Elderly Patients With Chronic Constipation
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Orocecal transit: Time of radioactive marker to reach the cecum using scintigraphy
Secondary outcome: 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
Eligibility
Minimum age: 65 Years.
Maximum age: N/A.
Gender(s): 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.
Locations and Contacts
Arkansas Gastroenterology, PA, North Little Rock, Arizona 72117, United States
University of Michigan Medical Center, Ann Arbor, Michigan 48109-0362, United States
Temple University Hospital, Philadelphia, Pennsylvania 19140, United States
Additional Information
Starting date: July 2006
Ending date: April 2007
Last updated: April 1, 2008
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