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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00232037
First Posted: October 4, 2005
Last Update Posted: February 1, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novartis
  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 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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 questionaire.
  • Efficacy on satisfactory relief at month 6 and 12.

Estimated Enrollment: 359
Study Start Date: September 2004
Study Completion Date: August 2006
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00232037


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

ClinicalTrials.gov Identifier: NCT00232037     History of Changes
Other Study ID Numbers: CHTF919D2301E1
First Submitted: September 8, 2005
First Posted: October 4, 2005
Last Update Posted: February 1, 2008
Last Verified: January 2008

Keywords provided by Novartis:
Dyspepsia, gastrointestinal, tegaserod

Additional relevant MeSH terms:
Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms
Tegaserod
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs