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...
Date First Received: September 8, 2005
Last Updated: January 31, 2008
Verified by: Novartis, January 2008
Clinical Trial Phase: Phase 3 | Start Date: September 2004
Overall Status: Completed
Estimated Enrollment: 359
Brief Summary
Official Title: “Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia”
Condition Keyword(s):
Intervention(s):
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 Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Intervention(s) in this Clinical Trial
- Drug: Tegaserod
Outcome Measures for this Clinical Trial
Primary Measures
- Long term safety at 6 months.
Secondary Measures
- Long term safety at 1 year.
- Quality of life : Nepean Dyspepsia Index, WPAI, patient perception of study medication-dyspepsia questionaire.
- Efficacy on satisfactory relief at month 6 and 12.
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Female, 18 years and older
- Fulfilled eligibility criteria in CHTF919D2301 (double blind study) and successfully completed the double-blind study
Exclusion Criteria:
- Early discontinuation from the double-blind study
- Other protocol-defined inclusion/exclusion criteria may apply
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Clinical Trial Sponsor Information
Lead Sponsor: Novartis
Overall Clinical Trial Officials and Contacts
Novartis Study Chair East Hanover NJ
Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00232037
Study ID Number: CHTF919D2301E1
ClinicalTrials.gov Identifier: NCT00232037
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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