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
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.
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
πΊπΈNorth Little Rock, Arizona, United States
University of Michigan Medical Center
πΊπΈAnn Arbor, Michigan, United States
Temple University Hospital
πΊπΈPhiladelphia, Pennsylvania, United States
Arkansas Gastroenterology, PAπΊπΈNorth Little Rock, Arizona, United States