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Efficacy, Safety and Tolerability of Tegaserod in Patients With Chronic Constipation

This study has been completed.
Information provided by:
Novartis Identifier:
First received: September 6, 2005
Last updated: January 31, 2008
Last verified: January 2008
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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Efficacy, Safety and Tolerability of Tegaserod in Patients With Chronic Constipation

Resource links provided by NLM:

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

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

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.

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Please refer to this study by its identifier: NCT00149877

Basel, Switzerland, 4056
Sponsors and Collaborators
Study Chair: Novartis Basel
  More Information Identifier: NCT00149877     History of Changes
Other Study ID Numbers: CHTF919EHK01
Study First Received: September 6, 2005
Last Updated: January 31, 2008

Keywords provided by Novartis:
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 processed this record on May 25, 2017