Assessment of Efficacy and Safety of Tegaserod in Male Patients With Chronic Constipation. - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00141089

Purpose

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.

Condition	Intervention	Phase
Chronic Constipation	Drug: Tegaserod	Phase III

MedlinePlus related topics: Constipation

Drug Information available for: Tegaserod Tegaserod maleate

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Assessment of Efficacy and Safety of Tegaserod in Male Patients With Chronic Constipation.

Further study details as provided by Novartis:

Primary Outcome Measures:

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 Outcome Measures:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00141089

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

Novartis Basel

More Information

Study ID Numbers:	CHTF919E2309
Study First Received:	August 31, 2005
Last Updated:	January 31, 2008
ClinicalTrials.gov Identifier:	NCT00141089
Health Authority:	United States: Institutional Review Board

Keywords provided by Novartis:

Male patients, chronic constipation, tegaserod

Study placed in the following topic categories:

Signs and Symptoms
Signs and Symptoms, Digestive
Constipation
Serotonin
Tegaserod

Additional relevant MeSH terms:

Serotonin Agonists
Neurotransmitter Agents
Serotonin Agents

Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009