Effect of Tegaserod on Orocecal Transit in Elderly Chronic Constipation Patients

• Sponsor: Novartis (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00348634
• Collaborator: Temple University (Other), University of Michigan (Other)
• Enrollment: 60
• Locations: 3
• Duration (Months): 9
• Patients Per Site: 20
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Constipation	Drug: Tegaserod	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: The Effects of Tegaserod on Orocecal Transit in Elderly Patients With Chronic Constipation
• Study Start Date: Jul 1, 2006
• Actual Primary Completion Date: Apr 1, 2007
• Actual Study Completion Date: Apr 1, 2007

Outcome Measures

Primary Outcome Measures

1. Orocecal transit: Time of radioactive marker to reach the cecum using scintigraphy []

Secondary Outcome Measures

1. 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 []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arkansas Gastroenterology, PA	North Little Rock	Arizona	United States	72117
2	University of Michigan Medical Center	Ann Arbor	Michigan	United States	48109-0362
3	Temple University Hospital	Philadelphia	Pennsylvania	United States	19140

Sponsors and Collaborators

• Novartis
• Temple University
• University of Michigan

Investigators

• Study Chair: Henry Parkman, MD, Temple
• Study Chair: William Chey, MD, University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis
• ClinicalTrials.gov Identifier: NCT00348634
• Other Study ID Numbers: CHTF919EUS51
• First Posted: Jul 4, 2006
• Last Update Posted: Mar 4, 2016
• Last Verified: Mar 1, 2016

• Keywords provided by Novartis: Constipation, Tegaserod, orocecal transit, colonic transit, gastric emptying
• Additional relevant MeSH terms: Constipation; Tegaserod

Study Results

No Results Posted as of Mar 4, 2016