Efficacy, Safety and Tolerability of Tegaserod in Patients With Chronic Constipation

• Status: Completed
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4

Details

• Lead Sponsor: Novartis
• Treatments: Tegaserod

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

• Evidence of cathartic colon or laxative abuse, pelvic floor dysfunction or neurological disorders

Other protocol-defined inclusion/exclusion criteria may apply.