- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00141089
Assessment of Efficacy and Safety of Tegaserod in Male Patients With Chronic Constipation.
January 31, 2008 updated by: Novartis
Tegaserod (HTF919) is an aminoguanidine indole compound and a member of a class of subgroup-selective 5-hydroxytryptamine (5-HT) agonists.
The aim of this study was to evaluate the efficacy and safety of tegaserod on bowel habits in male patients with chronic constipation.
Study Overview
Study Type
Interventional
Enrollment
1026
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- A 6-month history of constipation defined as <3 complete 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
- Past or current diagnosis of irritable bowel syndrome were excluded.
Other protocol-defined inclusion/exclusion criteria may apply.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Proportion of patients with mean increase of more than one complete spontaneous bowel movement (csbm) per week during the first 4 weeks of treatment compared to baseline.
|
Secondary Outcome Measures
Outcome Measure |
---|
Safety and tolerability.
|
For csbm and sbm : Increase of > or = of one/week for weeks 1 to 12 and week 1, absolute number for week 1 to 4 and 1 to 12, time to 1st csbm, sbm.
|
Daily assessment of bowel habits, patients assessment of bowel habits, constipation, distention/bloating, abdominal discomfort/pain, patients assessment of impact of constipation on quality of life, laxative use.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Novartis, Novartis Basel
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2004
Study Completion (Actual)
February 1, 2005
Study Registration Dates
First Submitted
August 31, 2005
First Submitted That Met QC Criteria
August 31, 2005
First Posted (Estimate)
September 1, 2005
Study Record Updates
Last Update Posted (Estimate)
February 1, 2008
Last Update Submitted That Met QC Criteria
January 31, 2008
Last Verified
January 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHTF919E2309
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Constipation
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usMIMA S.L.CompletedConstipation | Constipation Chronic Idiopathic | Constipation; NeurogenicSpain, United Kingdom
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University of MichiganCompletedKiwifruit, Prunes, & Fiber for Abdominal and Bowel Symptoms in US Patients With Chronic ConstipationChronic ConstipationUnited States
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EA Pharma Co., Ltd.CompletedChronic ConstipationJapan
Clinical Trials on Tegaserod
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NovartisCompleted
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NovartisCompletedDyspepsiaUnited States
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NovartisCompleted
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NovartisCompletedGastroesophageal Reflux Disease (GERD)United States
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NovartisCompletedIBS-C and IBS With Mixed Bowel Habits
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NovartisTerminatedDiabetes | GastroparesisUnited States
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NovartisCompletedChronic ConstipationSwitzerland