NCT00139568

Brief Summary

Tegaserod is an aminoguanidine indole compound and a member of a new class of 5-hydroxytryptamine (5-HT) agonists. Activation of 5-HT4 receptors triggers the release of neurotransmitters from the enteric nerves which in turn stimulate contractility and peristalsis. This study will investigate the efficacy and safety of tegaserod against chronic constipation in a Chinese population of adult men and women

Trial Health

87
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Feb 2005

Shorter than P25 for phase_3

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

February 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 31, 2005

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
Last Updated

February 1, 2008

Status Verified

January 1, 2008

First QC Date

August 30, 2005

Last Update Submit

January 31, 2008

Conditions

Constipation

Keywords

Chronic constipation5-HT,5-HT4,functional GIChinategaserod

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in number of complete spontaneous bowel movements (CSBM) per week

Secondary Outcomes (7)

  • Response rate for CSBM during the first 4 weeks of treatment

  • Patients' daily assessment of bowel habits

  • Patients' weekly assessment of constipation symptoms

  • Satisfactory relief of CC symptoms

  • PAC-QoL questionnaire

  • +2 more secondary outcomes

Interventions

TegaserodDRUG

Eligibility Criteria

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

You may qualify if:

  • Men or women at least 18 years of age
  • History of constipation for at least 6 months prior to screening
  • Normal bowel evaluation performed within the past 5 years

You may not qualify if:

  • Most bothersome symptom in last 6 months is abdominal pain/discomfort
  • Whose chronic constipation is thought to be a result of bowel surgery, gynecological surgery, neurologic disorder, systemic sclerosis, amyloidosis, scleroderma, myotonic dystrophy
  • Insulin dependent diabetes
  • Evidence of cathartic colon or laxative abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis

Basel, 4056, Switzerland

Location

MeSH Terms

Conditions

Constipation

Interventions

tegaserod

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Novartis

    Novartis Basel, Switzerland

    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 30, 2005

First Posted

August 31, 2005

Study Start

February 1, 2005

Study Completion

October 1, 2005

Last Updated

February 1, 2008

Record last verified: 2008-01

Locations

CH(1)