Back to resultsEfficacy, Safety and Tolerability of Tegaserod in Patients With Chronic Constipation
Primary Purpose
Chronic Constipation
Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Tegaserod
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Constipation focused on measuring Chronic constipation, tegaserod
Eligibility 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.
Sites / Locations
- Novartis
Outcomes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00149877
Brief Title
Efficacy, Safety and Tolerability of Tegaserod in Patients With Chronic Constipation
Official Title
Efficacy, Safety and Tolerability of Tegaserod in Patients With Chronic Constipation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Constipation
Keywords
Chronic constipation, tegaserod
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
250 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Tegaserod
Primary Outcome Measure Information:
Title
Number of complete spontaneous bowel movement (csbm) during the first 4 weeks of treatment.
Secondary Outcome Measure Information:
Title
Number of csbm during 8 weeks of treatment.
Title
Daily assessment of bowel habits:frequency, form, straining, feeling of complete evacuation.
Title
Daily patients' assessment: bowel habits, constipation, distention/bloating, abdominal discomfort pain.
Title
Laxative use.
Title
Safety and tolerability.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis
Organizational Affiliation
Basel
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
Efficacy, Safety and Tolerability of Tegaserod in Patients With Chronic Constipation
We'll reach out to this number within 24 hrs