Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia
This study has been completed.
Information provided by:
First received: September 8, 2005
Last updated: January 31, 2008
Last verified: January 2008
This study is being done to evaluate the long-term safety of tegaserod in women with symptoms of dyspepsia who have completed the core study. Tegaserod will be evaluated at 6 mg twice daily.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- Long term safety at 6 months.
Secondary Outcome Measures:
- 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.
|Study Start Date:||September 2004|
|Study Completion Date:||August 2006|
Contacts and Locations