Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia
|ClinicalTrials.gov Identifier: NCT00232102|
Recruitment Status : Completed
First Posted : October 4, 2005
Last Update Posted : February 1, 2008
|Condition or disease||Intervention/treatment||Phase|
|Dyspepsia||Drug: Tegaserod||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||423 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia|
|Study Start Date :||September 2004|
|Study Completion Date :||August 2006|
- Long term safety at 6 months.
- Long term safety at 1 year.
- Quality of life : Nepean Dyspepsia Index, WPAI, patient perception of study medication-dyspepsia questionnaire.
- Efficacy on satisfactory relief at month 6 and 12.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00232102
|United States, New Jersey|
|East Hanover, New Jersey, United States, 07936-108|
|Study Chair:||Novartis||East Hanover NJ|