Assessment of Efficacy and Safety of Tegaserod in Male Patients With Chronic Constipation.

• Sponsor: Novartis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00141089
• Collaborator: (none)
• Enrollment: 1,026
• Duration (Months): 11.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Constipation	Drug: Tegaserod	Phase 3

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Assessment of Efficacy and Safety of Tegaserod in Male Patients With Chronic Constipation.
• Study Start Date: Mar 1, 2004
• Actual Study Completion Date: Feb 1, 2005

Outcome Measures

Primary Outcome Measures

1. 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

1. 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. []

2. 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. []

3. Safety and tolerability. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Novartis

Investigators

• Study Chair: Novartis, Novartis Basel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00141089
• Other Study ID Numbers: CHTF919E2309
• First Posted: Sep 1, 2005
• Last Update Posted: Feb 1, 2008
• Last Verified: Jan 1, 2008

• Keywords provided by , ,: Male patients, chronic constipation, tegaserod
• Additional relevant MeSH terms: Constipation; Tegaserod

Study Results

No Results Posted as of Feb 1, 2008