An Evaluation of the Efficacy and Safety of Tegaserod 6 mg Bid Given Orally to Chinese Patients With Chronic Constipation

• Status: Completed
• Trial end date: 2005-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Tegaserod is an aminoguanidine indole compound and a member of a new class of 5-hydroxytryptamine (5-HT) agonists. Activation of 5-HT4 receptors triggers the release of neurotransmitters from the enteric nerves which in turn stimulate contractility and peristalsis. This study will investigate the efficacy and safety of tegaserod against chronic constipation in a Chinese population of adult men and women

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Tegaserod

Criteria

Inclusion Criteria:

• Men or women at least 18 years of age

• History of constipation for at least 6 months prior to screening

• Normal bowel evaluation performed within the past 5 years

Exclusion Criteria:

• Most bothersome symptom in last 6 months is abdominal pain/discomfort

• Whose chronic constipation is thought to be a result of bowel surgery, gynecological surgery, neurologic disorder, systemic sclerosis, amyloidosis, scleroderma, myotonic dystrophy

• Insulin dependent diabetes

• Evidence of cathartic colon or laxative abuse

Other inclusion/exclusion criteria may apply.