Efficacy, Safety and Tolerability of Tegaserod in Patients With Chronic Constipation
Study Details
Study Description
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, safety and tolerability of tegaserod on bowel habits in patients with CC.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Outcome Measures
Primary Outcome Measures
- Number of complete spontaneous bowel movement (csbm) during the first 4 weeks of treatment. []
Secondary Outcome Measures
- Number of csbm during 8 weeks of treatment. []
- Daily assessment of bowel habits:frequency, form, straining, feeling of complete evacuation. []
- Daily patients' assessment: bowel habits, constipation, distention/bloating, abdominal discomfort pain. []
- Laxative use. []
- Safety and tolerability. []
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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 Criteria:
-
Patients with cancer, inflammatory bowel disease or other structural bowel disease
-
Patients who participated in a prior tegaserod study
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Evidence of cathartic colon or laxative abuse, pelvic floor dysfunction or neurological disorders
Other protocol-defined inclusion/exclusion criteria may apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novartis | Basel | Switzerland | 4056 |
Sponsors and Collaborators
- Novartis
Investigators
- Study Chair: Novartis, Basel
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CHTF919EHK01