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

Novartis

Status and phase: Completed; Phase 3

Conditions: Dyspepsia

Treatments: Drug: Tegaserod

Study type: Interventional

Funder types: Industry

Identifiers

NCT00232102

CHTF919D2302E1

Details and patient eligibility

About

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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female, 18 years and older
• Fulfilled eligibility criteria in CHTF919 D2302 (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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)