Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00232037

Enrollment

359

Registered

2005-10-04

Start date

2004-09-30

Completion date

2006-08-31

Last updated

2008-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyspepsia

Keywords

Dyspepsia, gastrointestinal, tegaserod

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.

Interventions

DRUGTegaserod

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Inclusion criteria

* Female, 18 years and older * Fulfilled eligibility criteria in CHTF919D2301 (double blind study) and successfully completed the double-blind study

Exclusion criteria

\- Early discontinuation from the double-blind study Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Long term safety at 6 months.	—

Secondary

Measure	Time frame
Long term safety at 1 year.	—
Quality of life : Nepean Dyspepsia Index, WPAI, patient perception of study medication-dyspepsia questionaire.	—
Efficacy on satisfactory relief at month 6 and 12.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026