Status:

COMPLETED

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

Lead Sponsor:

Novartis

Conditions:

Dyspepsia

Eligibility:

FEMALE

18+ years

Phase:

PHASE3

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.

Eligibility Criteria

Inclusion

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

Exclusion

  • \- Early discontinuation from the double-blind study
  • Other protocol-defined inclusion/exclusion criteria may apply.

Key Trial Info

Start Date :

September 1 2004

Trial Type :

INTERVENTIONAL

End Date :

August 1 2006

Estimated Enrollment :

423 Patients enrolled

Trial Details

Trial ID

NCT00232102

Start Date

September 1 2004

End Date

August 1 2006

Last Update

February 1 2008

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Novartis

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