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 CHTF919D2301 (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 :
359 Patients enrolled
Trial Details
Trial ID
NCT00232037
Start Date
September 1 2004
End Date
August 1 2006
Last Update
February 1 2008
Active Locations (1)
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1
Novartis
East Hanover, New Jersey, United States, 07936-108