Efficacy, Safety and Tolerability of Tegaserod in 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: NCT00149877
Recruitment Status : Completed
First Posted : September 8, 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 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 or disease Intervention/treatment Phase
Chronic Constipation Drug: Tegaserod Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Efficacy, Safety and Tolerability of Tegaserod in Patients With Chronic Constipation
Study Start Date : April 2004
Actual Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Primary Outcome Measures :
  1. Number of complete spontaneous bowel movement (csbm) during the first 4 weeks of treatment.

Secondary Outcome Measures :
  1. Number of csbm during 8 weeks of treatment.
  2. Daily assessment of bowel habits:frequency, form, straining, feeling of complete evacuation.
  3. Daily patients' assessment: bowel habits, constipation, distention/bloating, abdominal discomfort pain.
  4. Laxative use.
  5. Safety and tolerability.

Information from the National Library of Medicine

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

Information from the National Library of Medicine

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): NCT00149877

Basel, Switzerland, 4056
Sponsors and Collaborators
Study Chair: Novartis Basel Identifier: NCT00149877     History of Changes
Other Study ID Numbers: CHTF919EHK01
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: February 1, 2008
Last Verified: January 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