Effect of Tegaserod on Orocecal Transit in Elderly Chronic Constipation Patients

Chronic Constipation Clinical Trial

Official title:

The Effects of Tegaserod on Orocecal Transit in Elderly Patients With Chronic Constipation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00348634
• Other study ID #: CHTF919EUS51
• Status: Terminated
• Phase: Phase 4
• First received: July 3, 2006
• Last updated: March 2, 2016
• Start date: July 2006
• Est. completion date: April 2007

Study information

• Verified date: March 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the effects of tegaserod on orocecal and colonic transit in patients over 65 years with chronic constipation.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Constipation
• Constipation

Intervention

Drug:
• Tegaserod

Locations

Country	Name	City	State
United States	University of Michigan Medical Center	Ann Arbor	Michigan
United States	Arkansas Gastroenterology, PA	North Little Rock	Arizona
United States	Temple University Hospital	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Novartis	Temple University, University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Orocecal transit: Time of radioactive marker to reach the cecum using scintigraphy
Secondary	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