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Assessment of the Effects of Tegaserod in the Management of Gastroesophageal Reflux Disease (GERD) in Patients With Incomplete Response to Proton Pump Inhibitors (PPIs).

This study has been completed.
Information provided by:
Novartis Identifier:
First received: September 12, 2005
Last updated: January 24, 2008
Last verified: January 2008
Study to assess the effects of adding tegaserod to PPI therapy results in clinically meaningful improvement of GERD symptoms in patients with incomplete relief of symptoms on daily PPI therapy alone.

Condition Intervention Phase
Gastroesophageal Reflux Disease (GERD)
Drug: Tegaserod
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessment of the Effects of Tegaserod in the Management of Gastroesophageal Reflux Disease (GERD) in Patients With Incomplete Response to Proton Pump Inhibitors (PPIs).

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • To determine the effect of 4 weeks of tegaserod treatment in addition to PPI on clinically meaningful incremental gain in improvement of overall GERD symptoms, based on weekly binary questions.

Secondary Outcome Measures:
  • To evaluate the sensitivity of three global symptom assessments, including two binary scales and a Likert-type scale along with a composite symptom index (end of treatment compared to baseline)
  • To evaluate frequency, severity and bothersomeness of individual GERD symptoms (daily assessments)
  • Safety assessment

Estimated Enrollment: 54
Study Start Date: June 2003
Study Completion Date: February 2005

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

Inclusion Criteria:

  • GERD symptoms for at least 6 months
  • PPI therapy for at least 4 weeks
  • Incomplete symptom relief on daily PPI therapy
  • No erosive disease as evidenced in EGD/no change in symptom severity

Exclusion Criteria:

  • Evidence of structural abnormality of the gastrointestinal tract or disease/conditions
  • Previous gastrointestinal surgery that may influence esophageal motor function
  • Known primary esophageal motor disorder other than Inefficient Esophageal Motor Disorder
  • Evidence of cathartic colon or a history of laxative use

Other protocol-defined inclusion/exclusion criteria may apply.

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Please refer to this study by its identifier: NCT00171418

United States, Louisiana
Drug Research Services, Inc
Metairie, Louisiana, United States, 70001
United States, Oklahoma
The Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
Study Director: Novartis Novartis
  More Information Identifier: NCT00171418     History of Changes
Other Study ID Numbers: CHTF919BUS26
Study First Received: September 12, 2005
Last Updated: January 24, 2008

Keywords provided by Novartis:

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Proton Pump Inhibitors
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Enzyme Inhibitors processed this record on May 23, 2017