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
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