Clinical Trial: Assessment of Efficacy and Safety of Tegaserod Treatment and Placebo in Women With Dyspepsia
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Assessment of Efficacy and Safety of Tegaserod Treatment and Placebo in Women With Dyspepsia
Brief Summary: This study is being done to evaluate the safety, tolerability and satisfactory relief of dyspepsia symptoms in females excluding those with predominant stomach pain. Tegaserod will be evaluated at 6mg twice daily and placebo.
Detailed Summary:
Sponsor: Novartis
Current Primary Outcome: Over 6 weeks of treatment assessment of percent of days with satisfactory relief of dyspepsia and/or average severity score in (average of post-prandial fullness early satiety and bloating)
Original Primary Outcome:
Current Secondary Outcome:
- Average severity score during each week.
- Percentage of days with satisfactory relief of dyspepsia during each week.
- Weekly global assessment of change in dyspepsia condition.
- Daily assessment of improvment of individual symptoms postprandial fullness early satiety, bloating, abdominal pain, nausea and vomiting.
- Quality of life at end of treatment compared to baseline.
- Safety and tolerability.
Original Secondary Outcome:
Information By: Novartis
Dates:
Date Received: September 8, 2005
Date Started: May 2004
Date Completion:
Last Updated: January 31, 2008
Last Verified: January 2008
