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

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.

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Key information

Conditions

Chronic Constipation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tegaserod

Drug

Primary outcomes

Proportion of patients with mean increase of more than one complete spontaneous bowel movement (csbm) per week during the first 4 weeks of treatment compared to baseline.

Secondary outcomes

For csbm and sbm : Increase of > or = of one/week for weeks 1 to 12 and week 1, absolute number for week 1 to 4 and 1 to 12, time to 1st csbm, sbm.
Daily assessment of bowel habits, patients assessment of bowel habits, constipation, distention/bloating, abdominal discomfort/pain, patients assessment of impact of constipation on quality of life, laxative use.
Safety and tolerability.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Important dates

Study start: 2004
Study completion: 2005
First posted: Sep 1, 2005
Registry last updated: Feb 1, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed