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

Chronic Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00141089
• Other study ID #: CHTF919E2309
• Status: Completed
• Phase: Phase 3
• First received: August 31, 2005
• Last updated: January 31, 2008
• Start date: March 2004
• Est. completion date: February 2005

Study information

• Verified date: January 2008
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1026
• Est. completion date: February 2005
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Constipation
• Constipation

Intervention

Drug:
• Tegaserod

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	Safety and tolerability.