Clinical Trial: Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia

Brief Summary: 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.

Detailed Summary:
Sponsor: Novartis

Current Primary Outcome: Long term safety at 6 months.

Original Primary Outcome:

Current Secondary Outcome:

  • 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.


Original Secondary Outcome:

Information By: Novartis

Dates:
Date Received: September 8, 2005
Date Started: September 2004
Date Completion:
Last Updated: January 31, 2008
Last Verified: January 2008