Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia
Sponsor
Novartis (Industry)
Overall Status
Completed
CT.gov ID
NCT00232037
Collaborator
(none)
359
1
23
15.6
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 3 |
Study Design
Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia
Study Start Date
:
Sep 1, 2004
Actual Study Completion Date
:
Aug 1, 2006
Outcome Measures
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. []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Female
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Novartis | East Hanover | New Jersey | United States | 07936-108 |
Sponsors and Collaborators
- Novartis
Investigators
- Study Chair: Novartis, East Hanover NJ
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00232037
Other Study ID Numbers:
- CHTF919D2301E1
First Posted:
Oct 4, 2005
Last Update Posted:
Feb 1, 2008
Last Verified:
Jan 1, 2008
Keywords provided by ,
,
Additional relevant MeSH terms: