An Evaluation of the Efficacy and Safety of Tegaserod 6 mg Bid Given Orally to Chinese Patients With Chronic Constipation
Phase 3
Completed
- Conditions
- Constipation
- Registration Number
- NCT00139568
- Lead Sponsor
- Novartis
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 600
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
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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.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from baseline in number of complete spontaneous bowel movements (CSBM) per week
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Novartis
🇨🇭Basel, Switzerland