Back to resultsAn Evaluation of the Efficacy and Safety of Tegaserod 6 mg Bid Given Orally to Chinese Patients With Chronic Constipation
Primary Purpose
Constipation
Status
Completed
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
Tegaserod
Sponsored by
About this trial
This is an interventional treatment trial for Constipation focused on measuring Chronic constipation, 5-HT,5-HT4,, functional GI, China, tegaserod
Eligibility 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.
Sites / Locations
- Novartis
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00139568
Brief Title
An Evaluation of the Efficacy and Safety of Tegaserod 6 mg Bid Given Orally to Chinese Patients With Chronic Constipation
Official Title
An Evaluation of the Efficacy and Safety of Tegaserod 6 mg Bid Given Orally to Chinese Patients With Chronic Constipation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
Chronic constipation, 5-HT,5-HT4,, functional GI, China, tegaserod
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
600 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Tegaserod
Primary Outcome Measure Information:
Title
Change from baseline in number of complete spontaneous bowel movements (CSBM) per week
Secondary Outcome Measure Information:
Title
Response rate for CSBM during the first 4 weeks of treatment
Title
Patients' daily assessment of bowel habits
Title
Patients' weekly assessment of constipation symptoms
Title
Satisfactory relief of CC symptoms
Title
PAC-QoL questionnaire
Title
PPSM questionnaire
Title
Safety
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis
Organizational Affiliation
Novartis Basel, Switzerland
Official's Role
Study Chair
Facility Information:
Facility Name
Novartis
City
Basel
ZIP/Postal Code
4056
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
An Evaluation of the Efficacy and Safety of Tegaserod 6 mg Bid Given Orally to Chinese Patients With Chronic Constipation
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