NCT00149877

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2004

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

February 1, 2008

Status Verified

January 1, 2008

First QC Date

September 6, 2005

Last Update Submit

January 31, 2008

Conditions

Chronic Constipation

Keywords

Chronic constipation, tegaserod

Outcome Measures

Primary Outcomes (1)

  • Number of complete spontaneous bowel movement (csbm) during the first 4 weeks of treatment.

Secondary Outcomes (5)

  • 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.

Interventions

TegaserodDRUG

Eligibility Criteria

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

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis

Basel, 4056, Switzerland

Location

MeSH Terms

Interventions

tegaserod

Study Officials

  • Novartis

    Basel

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

April 1, 2004

Study Completion

February 1, 2006

Last Updated

February 1, 2008

Record last verified: 2008-01

Locations

CH(1)