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

Phase 3

Completed

• Conditions: Dyspepsia

• Registration Number: NCT00232037
• Lead Sponsor: Novartis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-10-03
• Study First Posted: 2005-10-04
• Study Completion: 2006-08
• Status Verified: 2008-01
• Last Update Submitted: 2008-01-31
• Last Update Posted: 2008-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 359

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Long term safety at 6 months.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Novartis; 🇺🇸 East Hanover, New Jersey, United States