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...
Date First Received: September 6, 2005
Last Updated: January 31, 2008
Verified by: Novartis, January 2008
Clinical Trial Phase: Phase 4 | Start Date: April 2004
Overall Status: Completed
Estimated Enrollment: 250
Brief Summary
Official Title: “Efficacy, Safety and Tolerability of Tegaserod in Patients With Chronic Constipation”
Condition Keyword(s):
Intervention(s):
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.
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
- Number of complete spontaneous bowel movement (csbm) during the first 4 weeks of treatment.
Secondary 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.
Criteria for Participation in this Clinical Trial
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.
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 Basel
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00149877
Study ID Number: CHTF919EHK01
ClinicalTrials.gov Identifier: NCT00149877
Health Authority: China: State Food and Drug Administration
Clinical Trials Authorship and Review
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