Study Using Esomeprazole as a Diagnostic Test for GERD in Patients With NCCP
Status:
Completed
Trial end date:
2009-12-01
Target enrollment:
Participant gender:
Summary
Gastroesophageal reflux disease (GERD), with its cardinal symptom, heartburn, is the most
common disorder of the esophagus in the West. Comparatively, GERD is less common in Singapore
but its frequency in the population is increasing. Although the vast majority of patients
with GERD have heartburn and acid regurgitation, GERD can present in atypical ways, including
as a non-cardiac chest pain (NCCP). We have previously shown that GERD is a common cause of
NCCP in Singapore. Up to 40% of our patients with NCCP had endoscopic esophagitis, abnormal
24-hour pH monitoring results, and/or a positive acid perfusion test. These tests, although
diagnostic, are costly, labour intensive, and not always readily available in the primary
care setting. A trial of high-dose proton pump inhibitor (e.g. omeprazole 60 mg daily) has
been proposed as a simple, safe, non-invasive and reliable means to diagnose GERD in Western
patients with NCCP. We have not used the test routinely in our practice. This study will
evaluate the use of a short course of esomeprazole, the S-isomer of omeprazole, as a
diagnostic test for detecting GERD in patients with NCCP. The hypothesis is that in NCCP
patients with GERD, esomeprazole will resolve their symptoms. Consecutive patients diagnosed
with NCCP at the National University Hospital, Singapore, will be invited to participate in
the study. Eligible patients will be randomly assigned to receive either esomeprazole (40 mg
o d) for 14 days, or comparable dose of placebo at a similar schedule for 14 days, in a
double-blinded fashion. At the start of the study, all subjects will complete a baseline
symptom assessment. Symptoms will be scored on a graded scale based on severity. During the
study weeks, each patient will record his/her own daily symptoms. The patient will be
assessed again after the 14-day treatment. The primary outcome measure will be the change in
symptom score after initiation of treatment.