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

Novartis

Status and phase

Completed

Phase 3

Conditions

Constipation

Treatments

Drug: Tegaserod

Study type

Interventional

Funder types

Industry

Identifiers

NCT00139568

CHTF919E2308

Details and patient eligibility

About

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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.