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NCT00232037 Clinical Trial

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

Dyspepsia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00232037
Other study ID # CHTF919D2301E1
Secondary ID
Status Completed
Phase Phase 3
First received September 8, 2005
Last updated January 31, 2008
Start date September 2004
Est. completion date August 2006

Study information
Verified date January 2008
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 359
Est. completion date August 2006
Est. primary completion date
Accepts healthy volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Tegaserod

Locations
Country Name City State
United States Novartis East Hanover New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Long term safety at 6 months.
Secondary Long term safety at 1 year.
Secondary Quality of life : Nepean Dyspepsia Index, WPAI, patient perception of study medication-dyspepsia questionaire.
Secondary Efficacy on satisfactory relief at month 6 and 12.
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