Effect of Tegaserod on Orocecal Transit in Elderly Chronic Constipation Patients
Phase 4
Terminated
- Conditions
- Chronic Constipation
- Registration Number
- NCT00348634
- Lead Sponsor
- Novartis
- Brief Summary
This study will evaluate the effects of tegaserod on orocecal and colonic transit in patients over 65 years with chronic constipation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 60
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
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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.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Orocecal transit: Time of radioactive marker to reach the cecum using scintigraphy
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (3)
Arkansas Gastroenterology, PA
🇺🇸North Little Rock, Arizona, United States
University of Michigan Medical Center
🇺🇸Ann Arbor, Michigan, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States