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

Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00139568
• Other study ID #: CHTF919E2308
• Status: Completed
• Phase: Phase 3
• First received: August 30, 2005
• Last updated: January 31, 2008
• Start date: February 2005
• Est. completion date: October 2005

Study information

• Verified date: January 2008
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation

Intervention

Drug:
• Tegaserod

Locations

Country	Name	City	State
Switzerland	Novartis	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in number of complete spontaneous bowel movements (CSBM) per week
Secondary	Response rate for CSBM during the first 4 weeks of treatment
Secondary	Patients' daily assessment of bowel habits
Secondary	Patients' weekly assessment of constipation symptoms
Secondary	Satisfactory relief of CC symptoms
Secondary	PAC-QoL questionnaire
Secondary	PPSM questionnaire
Secondary	Safety