Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia
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...
Brief Summary
Official Title: “Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia”
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: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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 questionnaire.
- 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 CHTF919 D2302 (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 Investigator Information
Lead Investigator: Novartis Industry
Overall Clinical Trial Officials and Contacts
Novartis Study Chair East Hanover NJ
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00232102
Study ID Number: CHTF919D2302E1
ClinicalTrials.gov Identifier: NCT00232102
Health Authority: United States: Food and Drug Administration
Click here for more information about this study: Clinical trial of dyspepsia in females
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00232102
