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

This study has been completed.

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00232102

Purpose

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	Intervention	Phase
Dyspepsia	Drug: Tegaserod	Phase III

MedlinePlus related topics: Indigestion

Drug Information available for: Tegaserod Tegaserod maleate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia

Further study details as provided by Novartis:

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 questionnaire.
Efficacy on satisfactory relief at month 6 and 12.

Estimated Enrollment:	423
Study Start Date:	September 2004
Study Completion Date:	August 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00232102

Locations

United States, New Jersey
Novartis
East Hanover, New Jersey, United States, 07936-108

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

East Hanover NJ

More Information

Click here for more information about this study: Clinical trial of dyspepsia in females This link exits the ClinicalTrials.gov site

Study ID Numbers:	CHTF919D2302E1
Study First Received:	September 8, 2005
Last Updated:	January 31, 2008
ClinicalTrials.gov Identifier:	NCT00232102
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Dyspepsia, gastrointestinal, tegaserod

Study placed in the following topic categories:

Signs and Symptoms
Signs and Symptoms, Digestive
Dyspepsia
Serotonin
Tegaserod

Additional relevant MeSH terms:

Serotonin Agonists
Neurotransmitter Agents
Serotonin Agents

Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009