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

• Status: Completed
• Trial end date: 2005-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3

Details

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

Criteria

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.