Assessment of Efficacy and Safety of Tegaserod in Male Patients With Chronic Constipation.

Novartis

Status and phase: Completed; Phase 3

Conditions: Chronic Constipation

Treatments: Drug: Tegaserod

Study type: Interventional

Funder types: Industry

Identifiers

NCT00141089

CHTF919E2309

Details and patient eligibility

About

Tegaserod (HTF919) is an aminoguanidine indole compound and a member of a class of subgroup-selective 5-hydroxytryptamine (5-HT) agonists.

The aim of this study was to evaluate the efficacy and safety of tegaserod on bowel habits in male patients with chronic constipation.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A 6-month history of constipation defined as <3 complete 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
• Past or current diagnosis of irritable bowel syndrome were excluded.

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind