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

Phase 3CompletedNCT00232037

Novartis359 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

359

Conditions

Dyspepsia

Interventions

TegaserodDRUG

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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/exclusion criteria may apply

Locations (1)

Novartis

East Hanover, New Jersey, United States

Outcomes

Primary Outcomes

Long term safety at 6 months.

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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