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: NCT00232102
• Collaborator: (none)
• Enrollment: 423
• Location: 1
• Duration (Months): 23
• Patients Per Site Per Month: 18.4

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
Dyspepsia	Drug: Tegaserod	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

1. Long term safety at 6 months. []

Secondary Outcome Measures

1. Long term safety at 1 year. []

2. Quality of life : Nepean Dyspepsia Index, WPAI, patient perception of study medication-dyspepsia questionnaire. []

3. 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 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.

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

Additional Information:

• Click here for more information about this study: Clinical trial of dyspepsia in females

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00232102
• Other Study ID Numbers: CHTF919D2302E1
• First Posted: Oct 4, 2005
• Last Update Posted: Feb 1, 2008
• Last Verified: Jan 1, 2008

• Keywords provided by , ,: Dyspepsia, gastrointestinal, tegaserod
• Additional relevant MeSH terms: Dyspepsia; Tegaserod

Study Results

No Results Posted as of Feb 1, 2008