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).

• Status: Completed
• Trial end date: 2005-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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 .

• Phase: Phase 3

Details

• Lead Sponsor: Novartis
• Treatments: Proton Pump Inhibitors; Tegaserod

Criteria

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.