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
Verified date | January 2008 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Food and Drug Administration |
Study type | Interventional |
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
Status | Completed |
Enrollment | 600 |
Est. completion date | October 2005 |
Est. primary completion date | |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Switzerland | Novartis | Basel |
Lead Sponsor | Collaborator |
---|---|
Novartis |
Switzerland,
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 |
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