Status:
COMPLETED
An Evaluation of the Efficacy and Safety of Tegaserod 6 mg Bid Given Orally to Chinese Patients With Chronic Constipation
Lead Sponsor:
Novartis
Conditions:
Constipation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ente...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
End Date :
October 1 2005
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00139568
Start Date
February 1 2005
End Date
October 1 2005
Last Update
February 1 2008
Active Locations (1)
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1
Novartis
Basel, Switzerland, 4056