Official Title: “Assessment of the Role of Tegaserod Therapy in the Management of Gastroesophageal Reflux Disease (GERD) Symptoms in Patients With Incomplete Response to Proton Pump Inhibitors (PPIs).”

Study to assess the effects of tegaserod added to PPI therapy in the resolution of heartburn and regurgitation in patients with incomplete relief from PPIs .

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Tegaserod

Primary Measures

• To determine the effect of 6 weeks of tegaserod in addition to proton pump inhibitors on heartburn and regurgitation (weekly assessment)

Secondary Measures

• To evaluate the sensitivity of three global symptom assessments of GERD related to complaints (end of treatment compared to baseline)
• To evaluate frequency, severity and bothersomeness of individual GERD symptoms (daily assessments)
• To assess baseline characteristics that may predict a positive response to tegaserod add-on therapy in GERD patients
• To assess patient satisfaction with treatment (end of treatment)

Inclusion Criteria:

• Heartburn for at least 3 days in the week prior to screening
• Regurgitation for at least 3 days in the week prior to screening
• Stable dose PPI therapy > 4 weeks
• Incomplete relief on daily PPI therapy > 4 weeks

Exclusion Criteria:

• Evidence of structural abnormality of the gastrointestinal tract or disease/conditions
• Previous gastrointestinal surgery that may influence esophageal motor function
• 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: 70 Years

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Study Director Novartis  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00171483

Study ID Number: CHTF919BUS30

ClinicalTrials.gov Identifier: NCT00171483

Health Authority: United States: Food and Drug Administration