Efficacy, Safety and Tolerability of Tegaserod in Patients With Chronic Constipation
Phase 4
Completed
- Conditions
- Chronic Constipation
- Registration Number
- NCT00149877
- Lead Sponsor
- Novartis
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 250
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
- Evidence of cathartic colon or laxative abuse, pelvic floor dysfunction or neurological disorders
Other protocol-defined inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Number of complete spontaneous bowel movement (csbm) during the first 4 weeks of treatment.
- Secondary Outcome Measures
Name Time Method Laxative use. Safety and tolerability. 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.
Trial Locations
- Locations (1)
Novartis
🇨🇭Basel, Switzerland