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OpenTrials
Completed

NCT Number: NCT00232037

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.

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Key information

Conditions

Dyspepsia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Novartis

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tegaserod

Drug

Primary outcomes

  1. Long term safety at 6 months.

Secondary outcomes

  1. Long term safety at 1 year.

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

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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Important dates

Study start
2004
Study completion
2006
First posted
Oct 4, 2005
Registry last updated
Feb 1, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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