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An Evaluation of the Efficacy and Safety of Tegaserod 6 mg Bid Given Orally to Chinese Patients With Chronic Constipation

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00139568
First received: August 30, 2005
Last updated: January 31, 2008
Last verified: January 2008
History of Changes
  Purpose

Tegaserod is an aminoguanidine indole compound and a member of a new class of 5-hydroxytryptamine (5-HT) agonists. Activation of 5-HT4 receptors triggers the release of neurotransmitters from the enteric nerves which in turn stimulate contractility and peristalsis. This study will investigate the efficacy and safety of tegaserod against chronic constipation in a Chinese population of adult men and women


Condition Intervention Phase
Constipation
 Drug: Tegaserod
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: An Evaluation of the Efficacy and Safety of Tegaserod 6 mg Bid Given Orally to Chinese Patients With Chronic Constipation

Resource links provided by NLM:

MedlinePlus related topics: Constipation
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline in number of complete spontaneous bowel movements (CSBM) per week

Secondary Outcome Measures:
  • Response rate for CSBM during the first 4 weeks of treatment
  • Patients' daily assessment of bowel habits
  • Patients' weekly assessment of constipation symptoms
  • Satisfactory relief of CC symptoms
  • PAC-QoL questionnaire
  • PPSM questionnaire
  • Safety

Estimated Enrollment: 600
Study Start Date: February 2005
Study Completion Date: October 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men or women at least 18 years of age
  • History of constipation for at least 6 months prior to screening
  • Normal bowel evaluation performed within the past 5 years

Exclusion Criteria:

  • Most bothersome symptom in last 6 months is abdominal pain/discomfort
  • Whose chronic constipation is thought to be a result of bowel surgery, gynecological surgery, neurologic disorder, systemic sclerosis, amyloidosis, scleroderma, myotonic dystrophy
  • Insulin dependent diabetes
  • Evidence of cathartic colon or laxative abuse

Other inclusion/exclusion criteria may apply.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00139568

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

No publications provided

ClinicalTrials.gov Identifier: NCT00139568     History of Changes
Other Study ID Numbers: CHTF919E2308
Study First Received: August 30, 2005
Last Updated: January 31, 2008
Health Authority: China: Food and Drug Administration

Keywords provided by Novartis:
Chronic constipation
5-HT,5-HT4,
functional GI
China
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 22, 2013