Validation of RDQ Questionnaire

A Single-Blind Single Arm Study to Validate the Reflux Disease Questionnaire (RDQ) for the Diagnosis of Reflux Disease in Primary Care in Patients Treated With Esomeprazole 40 mg o.d.

The primary objective of this study is to determine the accuracy of the Reflux Disease Questionnaire (RDQ) as a diagnostic test for gastroesophageal reflux disease. Symptom evaluation by the RDQ will be compared with other established approaches to the diagnosis of gastroesophageal reflux disease (GERD) in a primary care patient population with symptoms thought to be of upper gastrointestinal (GI) tract origin.

Inclusion Criteria:

• Subjects who seek medical advice at their family doctor (primary care physician) for symptoms thought by the primary care physician to arise from the upper GI tract
• The symptoms thought to pertain to the upper GI tract must have been present for at least 4 weeks prior to Visit 1 and to have occurred at least twice a week during that period
• The symptoms thought to pertain to the upper GI tract must have been of at least mild severity for a minimum of 3 days during the week prior to Visit 1

Exclusion Criteria:

• Upper GI endoscopy performed within a year prior to Visit 1
• Previous anti-reflux surgery, surgery for peptic ulcer or any form of upper gastrointestinal resective surgery
• Contra-indication to the Bravo™ procedure such as subjects with a history of bleeding diathesis, strictures anywhere along the GI-tract, esophageal varices, obstructions, or subjects equipped with a pacemaker, an implantable cardiac defibrillator or an implantable neurostimulator (NB: subjects with severe esophagitis (grade D) confirmed by endoscopy at Visit 2 can continue the study without performing the Bravo™ procedure)