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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00141089
Recruitment Status : Completed
First Posted : September 1, 2005
Last Update Posted : February 1, 2008
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Brief Summary:

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 or disease Intervention/treatment Phase
Chronic Constipation Drug: Tegaserod Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 1026 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Assessment of Efficacy and Safety of Tegaserod in Male Patients With Chronic Constipation.
Study Start Date : March 2004
Actual Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Primary Outcome Measures :
  1. 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 :
  1. 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.
  2. 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.
  3. Safety and tolerability.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All

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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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00141089

Sponsors and Collaborators
Study Chair: Novartis Novartis Basel Identifier: NCT00141089     History of Changes
Other Study ID Numbers: CHTF919E2309
First Posted: September 1, 2005    Key Record Dates
Last Update Posted: February 1, 2008
Last Verified: January 2008

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

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs