NCT00141089

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,026

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Mar 2004

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2005

Completed
Last Updated

February 1, 2008

Status Verified

January 1, 2008

First QC Date

August 31, 2005

Last Update Submit

January 31, 2008

Conditions

Chronic Constipation

Keywords

Male patients, chronic constipation, tegaserod

Outcome Measures

Primary Outcomes (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 Outcomes (3)

  • 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.

Interventions

TegaserodDRUG

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients with cancer, inflammatory bowel disease or other structural bowel disease
  • Past or current diagnosis of irritable bowel syndrome were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

tegaserod

Study Officials

  • Novartis

    Novartis Basel

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 31, 2005

First Posted

September 1, 2005

Study Start

March 1, 2004

Study Completion

February 1, 2005

Last Updated

February 1, 2008

Record last verified: 2008-01