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...
Date First Received: August 30, 2005
Last Updated: January 31, 2008
Verified by: Novartis, January 2008
Clinical Trial Phase: Phase 3 | Start Date: February 2005
Overall Status: Completed
Estimated Enrollment: 600
Brief Summary
Official Title: “An Evaluation of the Efficacy and Safety of Tegaserod 6 mg Bid Given Orally to Chinese Patients With Chronic Constipation”
Condition Keyword(s):
Intervention(s):
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
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Tegaserod
Outcome Measures for this Clinical Trial
Primary Measures
- Change from baseline in number of complete spontaneous bowel movements (CSBM) per week
Secondary 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
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Novartis
Overall Clinical Trial Officials and Contacts
Novartis Study Chair Novartis Basel, Switzerland
Additional Information
Information obtained from ClinicalTrials.gov on August 20, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00139568
Study ID Number: CHTF919E2308
ClinicalTrials.gov Identifier: NCT00139568
Health Authority: China: State Food and Drug Administration
Clinical Trials Authorship and Review
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