Clinical Trial: Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia
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 Summary:
Sponsor: Novartis
Current Primary Outcome: Long term safety at 6 months.
Original Primary Outcome:
Current Secondary Outcome:
- 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.
Original Secondary Outcome:
Information By: Novartis
Dates:
Date Received: September 8, 2005
Date Started: September 2004
Date Completion:
Last Updated: January 31, 2008
Last Verified: January 2008