We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00149877
First Posted: September 8, 2005
Last Update Posted: February 1, 2008
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.
Information provided by:
Novartis
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT00149877


Locations
Switzerland
Novartis
Basel, Switzerland, 4056
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Basel
  More Information

ClinicalTrials.gov Identifier: NCT00149877     History of Changes
Other Study ID Numbers: CHTF919EHK01
First Submitted: September 6, 2005
First Posted: September 8, 2005
Last Update Posted: February 1, 2008
Last Verified: January 2008

Keywords provided by Novartis:
Chronic constipation, tegaserod

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