The Role of Tegaserod Therapy in the Management of Dyspeptic Symptoms in Female Patients on Proton Pump Inhibitors for the Treatment of Heartburn.

• Status: Completed
• Trial end date: 2006-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

Study to provide initial data to assess the safety and efficacy of tegaserod use in patients with dyspepsia that are being treated with proton pump inhibitors (PPI's) for heartburn.

• Phase: Phase 3

Details

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

Criteria

Inclusion Criteria:

• Female patients 18 years or older.

• Self-reported presence of symptoms consistent with dyspepsia (including mid-upper abdominal discomfort characterized by post prandial fullness, early satiety and bloating)

• Stable dose PPI therapy of at least 4 weeks

Exclusion Criteria:

• History of intestinal obstruction, symptomatic gallbladder disease, suspected sphincter of Oddi dysfunction, or of abdominal adhesions.

• Evidence that the dyspeptic symptoms are relieved by defecation and/or associated with a change in frequency or stool form.

• With a current most bothersome symptom of heartburn.

Other protocol-defined inclusion/exclusion criteria may apply.