Efficacy, Safety and Tolerability of Tegaserod in Patients With Chronic Constipation
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Efficacy, Safety and Tolerability of Tegaserod in Patients With Chronic Constipation|
- Number of complete spontaneous bowel movement (csbm) during the first 4 weeks of treatment.
- 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.
|Study Start Date:||April 2004|
|Study Completion Date:||February 2006|