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

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...

Date First Received: September 12, 2005

Last Updated: January 24, 2008

Verified by: Novartis, January 2008

Clinical Trial Phase: Phase 3 | Start Date: June 2003

Overall Status: Completed

Estimated Enrollment: 54

Brief Summary

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).”

Intervention(s):

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

  • Drug: Tegaserod

Outcome Measures for this Clinical Trial

Primary 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 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

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Clinical Trial Sponsor Information

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Study Director Novartis  

Additional Information

Information obtained from ClinicalTrials.gov on December 03, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00171418

Study ID Number: CHTF919BUS26

ClinicalTrials.gov Identifier: NCT00171418

Health Authority: United States: Food and Drug Administration

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