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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00149877
First received: September 6, 2005
Last updated: January 31, 2008
Last verified: January 2008
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00149877

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

No publications provided

ClinicalTrials.gov Identifier: NCT00149877     History of Changes
Other Study ID Numbers: CHTF919EHK01
Study First Received: September 6, 2005
Last Updated: January 31, 2008
Health Authority: China: Food and Drug Administration

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
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013