Assessment of Efficacy and Safety of Tegaserod Treatment and Placebo in Women With Dyspepsia
|ClinicalTrials.gov Identifier: NCT00232089|
Recruitment Status : Completed
First Posted : October 4, 2005
Last Update Posted : November 18, 2016
|Condition or disease||Intervention/treatment||Phase|
|Dyspepsia||Drug: Tegaserod||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||1296 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Assessment of Efficacy and Safety of Tegaserod Treatment and Placebo in Women With Dyspepsia|
|Study Start Date :||May 2004|
|Actual Primary Completion Date :||June 2006|
|Actual Study Completion Date :||June 2006|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00232089
|United States, New Jersey|
|East Hanover, New Jersey, United States, 07936-108|
|Study Chair:||Novartis||East Hanover NJ|