Status:
COMPLETED
Efficacy, Safety and Tolerability of Tegaserod in Patients With Chronic Constipation
Lead Sponsor:
Novartis
Conditions:
Chronic Constipation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Tegaserod (HTF919) is an aminoguanidine indole compound and a member of a new class of subgroup-selective 5-hydroxytryptamine (5-HT) agonists. The aim of this study is to investigate the efficacy, saf...
Eligibility Criteria
Inclusion
- Male and females of at least 18 years of age
- A 12-month history of constipation (defined as \< three spontaneous bowel movements per week and ≥1 of the following symptoms \>25% of the time: hard stools, sensation of incomplete evacuation and straining)
Exclusion
- Patients with cancer, inflammatory bowel disease or other structural bowel disease
- Patients who participated in a prior tegaserod study
- Evidence of cathartic colon or laxative abuse, pelvic floor dysfunction or neurological disorders
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
End Date :
February 1 2006
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00149877
Start Date
April 1 2004
End Date
February 1 2006
Last Update
February 1 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis
Basel, Switzerland, 4056