Back to resultsExtension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia
Primary Purpose
Dyspepsia
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tegaserod
Sponsored by
About this trial
This is an interventional treatment trial for Dyspepsia focused on measuring Dyspepsia, gastrointestinal, tegaserod
Eligibility Criteria
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
Sites / Locations
- Novartis
Outcomes
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 questionaire.
Efficacy on satisfactory relief at month 6 and 12.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00232037
Brief Title
Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia
Official Title
Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspepsia
Keywords
Dyspepsia, gastrointestinal, tegaserod
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
359 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Tegaserod
Primary Outcome Measure Information:
Title
Long term safety at 6 months.
Secondary Outcome Measure Information:
Title
Long term safety at 1 year.
Title
Quality of life : Nepean Dyspepsia Index, WPAI, patient perception of study medication-dyspepsia questionaire.
Title
Efficacy on satisfactory relief at month 6 and 12.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis
Organizational Affiliation
East Hanover NJ
Official's Role
Study Chair
Facility Information:
Facility Name
Novartis
City
East Hanover
State/Province
New Jersey
ZIP/Postal Code
07936-108
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia
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