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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00232037
First received: September 8, 2005
Last updated: January 31, 2008
Last verified: January 2008

September 8, 2005
January 31, 2008
September 2004
Not Provided
Long term safety at 6 months.
Not Provided
Complete list of historical versions of study NCT00232037 on ClinicalTrials.gov Archive Site
  • 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.
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Not Provided
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Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia
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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Dyspepsia
Drug: Tegaserod
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
359
August 2006
Not Provided

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

Female
18 Years and older
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00232037
CHTF919D2301E1
Not Provided
Not Provided
Novartis
Not Provided
Study Chair: Novartis East Hanover NJ
Novartis
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP