NCT00232102

Brief Summary

This study is being done to evaluate the long-term safety of tegaserod in women with symptoms of dyspepsia who have completed the core study. Tegaserod will be evaluated at 6 mg twice daily.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
423

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 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

September 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
26 days until next milestone

First Posted

Study publicly available on registry

October 4, 2005

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

February 1, 2008

Status Verified

January 1, 2008

First QC Date

September 8, 2005

Last Update Submit

January 31, 2008

Conditions

Dyspepsia

Keywords

Dyspepsia, gastrointestinal, tegaserod

Outcome Measures

Primary Outcomes (1)

  • Long term safety at 6 months.

Secondary Outcomes (3)

  • Long term safety at 1 year.

  • Quality of life : Nepean Dyspepsia Index, WPAI, patient perception of study medication-dyspepsia questionnaire.

  • Efficacy on satisfactory relief at month 6 and 12.

Interventions

TegaserodDRUG

Eligibility Criteria

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

You may qualify if:

  • Female, 18 years and older
  • Fulfilled eligibility criteria in CHTF919 D2302 (double blind study) and successfully completed the double-blind study

You may not qualify if:

  • \- Early discontinuation from the double-blind study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis

East Hanover, New Jersey, 07936-108, United States

Location

Related Links

MeSH Terms

Conditions

Dyspepsia

Interventions

tegaserod

Condition Hierarchy (Ancestors)

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

Study Officials

  • Novartis

    East Hanover NJ

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 8, 2005

First Posted

October 4, 2005

Study Start

September 1, 2004

Study Completion

August 1, 2006

Last Updated

February 1, 2008

Record last verified: 2008-01

Locations

US(1)