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

Novartis600 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

600

Conditions

Constipation

Interventions

TegaserodDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Novartis

Basel, Switzerland

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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