Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia
Phase 3
Completed
- Conditions
- Dyspepsia
- Registration Number
- NCT00232102
- 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
- 423
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.
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 questionnaire. Efficacy on satisfactory relief at month 6 and 12.
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie tegaserod's efficacy in functional dyspepsia as studied in NCT00232102?
How does the long-term safety of tegaserod 6 mg BID compare to standard prokinetic agents in dyspepsia patients?
Are there biomarkers associated with sustained response to 5-HT4 receptor agonists like tegaserod in NCT00232102?
What cardiovascular adverse events were reported in NCT00232102's Phase 3 tegaserod extension study for dyspepsia?
How does tegaserod's safety profile in NCT00232102 inform its potential use alongside PPIs for dyspepsia management?
Trial Locations
- Locations (1)
Novartis
🇺🇸East Hanover, New Jersey, United States
Novartis🇺🇸East Hanover, New Jersey, United States