Effect of Tegaserod on Orocecal Transit in Elderly Chronic Constipation Patients
This study will evaluate the effects of tegaserod on orocecal and colonic transit in patients over 65 years with chronic constipation...
Brief Summary
Official Title: “The Effects of Tegaserod on Orocecal Transit in Elderly Patients With Chronic Constipation”
This study will evaluate the effects of tegaserod on orocecal and colonic transit in patients over 65 years with chronic constipation.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: Tegaserod
Outcome Measures for this Clinical Trial
Primary Measures
- Orocecal transit: Time of radioactive marker to reach the cecum using scintigraphy
Secondary 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
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 65 Years
Maximum Age for this Clinical Trial: N/A
Clinical Trial Investigator Information
Lead Investigator: Novartis Industry
Overall Clinical Trial Officials and Contacts
Henry Parkman, MD Study Chair Temple
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00348634
Study ID Number: CHTF919EUS51
ClinicalTrials.gov Identifier: NCT00348634
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00348634
