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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:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00232037
First received: September 8, 2005
Last updated: January 31, 2008
Last verified: January 2008
History of Changes
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Indigestion
U.S. FDA Resources

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

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

No publications provided

ClinicalTrials.gov Identifier: NCT00232037     History of Changes
Other Study ID Numbers: CHTF919D2301E1
Study First Received: September 8, 2005
Last Updated: January 31, 2008
Health Authority: United States: Food and Drug Administration

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
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013