Assessment of Efficacy and Safety of Tegaserod Treatment and Placebo in Women With Dyspepsia
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Assessment of Efficacy and Safety of Tegaserod Treatment and Placebo in Women With Dyspepsia|
- 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)
- 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.
|Study Start Date:||January 2004|
|Study Completion Date:||May 2006|