Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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)|
|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|
|Actual 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.
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): NCT00232102
|United States, New Jersey|
|East Hanover, New Jersey, United States, 07936-108|
|Study Chair:||Novartis||East Hanover NJ|