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

Novartis

Status and phase

Completed

Phase 3

Conditions

Dyspepsia

Treatments

Drug: Tegaserod

Study type

Interventional

Funder types

Industry

Identifiers

NCT00171470

CHTF919DUS46

Details and patient eligibility

About

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.

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.