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An Evaluation of the Efficacy and Safety of Tegaserod 6 Mg Bid Given Orally to Chinese Patients with Chronic Constipation - Article


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Tegaserod

tegaserod maleate; Zelnorm


Clinical Trial: An Evaluation of the Efficacy and Safety of Tegaserod 6 Mg Bid Given Orally to Chinese Patients with Chronic Constipation

This study is currently recruiting patients.
Verified by Novartis August 2005

Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00139568

Purpose

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 Intervention Phase
Chronic constipation
 Drug: Tegaserod
Phase III

MedlinePlus related topics:  Constipation

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further Study Details: 

Study start: February 2005

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
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 dystrophyInsulin dependent diabetes • Evidence of cathartic colon or laxative abuse

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00139568

Novartis      +41 61 324  Ext. 1111 

Switzerland
      Novartis, Basel,  4056,  Switzerland; Recruiting
Novartis  +41 61 324  Ext. 1111 

Study chairs or principal investigators

Novartis,  Study Chair,  Novartis Basel, Switzerland   

More Information

Study ID Numbers:  CHTF919E2308
Last Updated:  August 30, 2005
Record first received:  August 30, 2005
ClinicalTrials.gov Identifier:  NCT00139568
Health Authority: China: State Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-06


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Page Updated: September 6, 2005
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