Assessment of Efficacy and Safety of Tegaserod in Male Patients With Chronic Constipation.
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Constipation
Intervention: Tegaserod (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis, Study Chair, Affiliation: Novartis Basel
Summary
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.
Clinical Details
Official title: Assessment of Efficacy and Safety of Tegaserod in Male Patients With Chronic Constipation.
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Additional Information
Starting date: March 2004
Ending date: February 2005
Last updated: January 31, 2008
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