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

This study has been completed.
Information provided by:
Novartis Identifier:
First received: August 31, 2005
Last updated: January 31, 2008
Last verified: January 2008

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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Assessment of Efficacy and Safety of Tegaserod in Male Patients With Chronic Constipation.

Resource links provided by NLM:

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.

Estimated Enrollment: 1026
Study Start Date: March 2004
Study Completion Date: February 2005

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

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.

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Please refer to this study by its identifier: NCT00141089

Sponsors and Collaborators
Study Chair: Novartis Novartis Basel
  More Information Identifier: NCT00141089     History of Changes
Other Study ID Numbers: CHTF919E2309 
Study First Received: August 31, 2005
Last Updated: January 31, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Novartis:
Male patients, chronic constipation, tegaserod

Additional relevant MeSH terms:
Signs and Symptoms
Signs and Symptoms, Digestive
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Serotonin Agents
Serotonin Receptor Agonists processed this record on May 26, 2016