Study Using Esomeprazole as a Diagnostic Test for GERD in Patients With NCCP (ECP)

This study has been completed.
Sponsor:
Information provided by:
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT00786695
First received: November 4, 2008
Last updated: March 2, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention
Gastroesophageal Reflux Disease
Drug: esomeprazole
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Official Title: Esomeprazole as a Diagnostic Test for Gastroesophageal Reflux Disease in Patients With Noncardiac Chest Pain

Resource links provided by NLM:


Further study details as provided by National University Hospital, Singapore:

Primary Outcome Measures:
  • symptom resolution [ Time Frame: 14 days of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: May 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Identical looking Placebo
Drug: Placebo
Identical looking Placebo, same regimen, for 14 days
Experimental: esomeprazole
esomeprazole (40 mg o d) for 14 days
Drug: esomeprazole
esomeprazole (40 mg o d) for 14 days
Other Name: nexium

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with recurrent chest pain of more than three months duration with either (1) normal or non-obstructive coronary arteries (<50% luminal diameter narrowing), (2) normal dobutamine stress echocardiography or (3) a negative exercise electrocardiogram and a cardiologist's evaluation that symptoms are not cardiac in origin.

Exclusion Criteria:

  • Patients will be excluded if they are < 18 or > 70 years old, are pregnant, have a medical contraindication for esomeprazole therapy, have already been empirically treated with an antireflux regimen, report a history of peptic ulcer disease or gastrointestinal surgery, or are unwilling or unable to provide informed consent. In addition, patients who are unable to fully complete all stages of the study will be excluded.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00786695

Locations
Singapore
National University Hospital
Singapore, Singapore, 119074
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
Principal Investigator: Khek Yu Ho, MD National University Hospital, Singapore
  More Information

Publications:

Responsible Party: Khek Yu Ho / Professor, National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT00786695     History of Changes
Other Study ID Numbers: D/00/764
Study First Received: November 4, 2008
Last Updated: March 2, 2011
Health Authority: Singapore: Domain Specific Review Boards

Keywords provided by National University Hospital, Singapore:
noncardiac chest pain
gastroesophageal reflux disease
diagnostic test
proton pump inhibitor
esomeprazole

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Proton Pump Inhibitors
Omeprazole
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 22, 2014