Status:
TERMINATED
Effect of Tegaserod on Orocecal Transit in Elderly Chronic Constipation Patients
Lead Sponsor:
Novartis
Collaborating Sponsors:
Temple University
University of Michigan
Conditions:
Chronic Constipation
Eligibility:
All Genders
65+ years
Phase:
PHASE4
Brief Summary
This study will evaluate the effects of tegaserod on orocecal and colonic transit in patients over 65 years with chronic constipation.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2007
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00348634
Start Date
July 1 2006
End Date
April 1 2007
Last Update
March 4 2016
Active Locations (3)
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1
Arkansas Gastroenterology, PA
North Little Rock, Arizona, United States, 72117
2
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109-0362
3
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140