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

Sponsor

Novartis (Industry)

Overall Status

Completed

CT.gov ID

NCT00139568

Collaborator

(none)

600

Enrollment

Location

Duration (Months)

75.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Constipation	Drug: Tegaserod	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2005

Actual Study Completion Date :

Oct 1, 2005

Outcome Measures

Primary Outcome Measures

Change from baseline in number of complete spontaneous bowel movements (CSBM) per week []

Secondary Outcome Measures

Response rate for CSBM during the first 4 weeks of treatment []
Patients' daily assessment of bowel habits []
Patients' weekly assessment of constipation symptoms []
Satisfactory relief of CC symptoms []
PAC-QoL questionnaire []
PPSM questionnaire []
Safety []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.