Effect of Tegaserod on Orocecal Transit in Elderly Chronic Constipation Patients

Novartis

Status and phase: Terminated; Phase 4

Conditions: Chronic Constipation

Treatments: Drug: Tegaserod

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00348634

CHTF919EUS51

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind