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 postprandial fullness early satiety and bloating)
- Weekly assessment of satisfactory relief of dyspepsia.
- Daily assessment of percentage of patients responding on average severity score.
- For each week assessment of average daily severity score.
- Percentage of days with satisfactory relief of dyspepsia during each week.
- Weekly global assessment of change in dyspepsia condition.
- Weekly assessment of individual symptoms score of 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:||May 2004|
|Study Completion Date:||June 2006|
|Primary Completion Date:||June 2006 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00232089
|United States, New Jersey|
|East Hanover, New Jersey, United States, 07936-108|
|Study Chair:||Novartis||East Hanover NJ|