Efficacy, Safety and Tolerability of Tegaserod in Patients With Chronic Constipation - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00149877

Purpose

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.

Condition	Intervention	Phase
Chronic Constipation	Drug: Tegaserod	Phase IV

MedlinePlus related topics: Constipation

Drug Information available for: Tegaserod Tegaserod maleate

U.S. FDA Resources

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

Further study details as provided by Novartis:

Primary Outcome Measures:

Number of complete spontaneous bowel movement (csbm) during the first 4 weeks of treatment.

Secondary Outcome Measures:

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.

Estimated Enrollment:	250
Study Start Date:	April 2004
Study Completion Date:	February 2006

Eligibility

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

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00149877

Locations

Switzerland
Novartis
Basel, Switzerland, 4056

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

Basel

More Information

Study ID Numbers:	CHTF919EHK01
Study First Received:	September 6, 2005
Last Updated:	January 31, 2008
ClinicalTrials.gov Identifier:	NCT00149877
Health Authority:	China: State Food and Drug Administration

Keywords provided by Novartis:

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 16, 2009