Assessment of Efficacy and Safety of Tegaserod Treatment and Placebo in Women With Dyspepsia
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|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)|
|Estimated 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|
|Primary Completion Date :||June 2006|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|