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: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Tegaserod

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

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

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Henry Parkman, MD Study Chair Temple  

Information obtained from ClinicalTrials.gov on August 20, 2008

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