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...
Date First Received: August 31, 2005
Last Updated: January 31, 2008
Verified by: Novartis, January 2008
Clinical Trial Phase: Phase 3 | Start Date: March 2004
Overall Status: Completed
Estimated Enrollment: 1026
Brief Summary
Official Title: “Assessment of Efficacy and Safety of Tegaserod in Male Patients With Chronic Constipation.”
Condition Keyword(s):
Intervention(s):
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 Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Tegaserod
Outcome Measures for this Clinical Trial
Primary Measures
- 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 Measures
- 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.
- Safety and tolerability.
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Clinical Trial Sponsor Information
Lead Sponsor: Novartis
Overall Clinical Trial Officials and Contacts
Novartis Study Chair Novartis Basel
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00141089
Study ID Number: CHTF919E2309
ClinicalTrials.gov Identifier: NCT00141089
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
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