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Study Using Esomeprazole as a Diagnostic Test for GERD in Patients With NCCP (ECP)
This study is currently recruiting participants.
Verified by National University Hospital, Singapore, November 2009
First Received: November 4, 2008   Last Updated: November 22, 2009   History of Changes
Sponsor: National University Hospital, Singapore
Information provided by: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT00786695
  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: Diagnostic, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment
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
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo: Placebo Comparator
Identical looking Placebo
Drug: Placebo
Identical looking Placebo, same regimen, for 14 days
esomeprazole: Experimental
esomeprazole (40 mg o d) for 14 days
Drug: esomeprazole
esomeprazole (40 mg o d) for 14 days

  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

Contacts
Contact: Khek Yu Ho, MD 65-67724362 mdchoky@nus.edu.sg

Locations
Singapore
National University Hospital Recruiting
Singapore, Singapore, 119074
Contact: Siok Chiang Fan     65-67724084     mdcfsc@nus.edu.sg    
Principal Investigator: Khek Yu Ho, MD            
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
Principal Investigator: Khek Yu Ho, MD National University Hospital, Singapore
  More Information

Publications:
Ho KY. Gastroesophageal reflux disease is uncommon in Asia: evidence and possible explanations. World J Gastroenterol. 1999 Feb;5(1):4-6. No abstract available.
Lim LG, Ho KY. Gastroesophageal reflux disease at the turn of millennium. World J Gastroenterol. 2003 Oct;9(10):2135-6. Review.
Ho KY. Gastroesophageal reflux disease in Asia: a condition in evolution. J Gastroenterol Hepatol. 2008 May;23(5):716-22. Review.
Ho KY, Gwee KA, Khor JL, Selamat DS, Yeoh KG. Validation of a graded response questionnaire for the diagnosis of gastroesophageal reflux disease in an Asian primary care population. J Clin Gastroenterol. 2008 Jul;42(6):680-6.
Ho KY, Cheung TK, Wong BC. Gastroesophageal reflux disease in Asian countries: disorder of nature or nurture? J Gastroenterol Hepatol. 2006 Sep;21(9):1362-5. Review.
Lim SL, Goh WT, Lee JM, Ng TP, Ho KY; Community Medicine GI Study Group. Changing prevalence of gastroesophageal reflux with changing time: longitudinal study in an Asian population. J Gastroenterol Hepatol. 2005 Jul;20(7):995-1001.
Ho KY, Kang JY, Yeo B, Ng WL. Non-cardiac, non-oesophageal chest pain: the relevance of psychological factors. Gut. 1998 Jul;43(1):105-10.
Ho KY, Kang JY, Seow A. Prevalence of gastrointestinal symptoms in a multiracial Asian population, with particular reference to reflux-type symptoms. Am J Gastroenterol. 1998 Oct;93(10):1816-22.
Ho KY, Kang JY, Seow A. Patterns of consultation and treatment for heartburn: findings from a Singaporean community survey. Aliment Pharmacol Ther. 1999 Aug;13(8):1029-33.
Ho KY, Kang JY. Reflux esophagitis patients in Singapore have motor and acid exposure abnormalities similar to patients in the Western hemisphere. Am J Gastroenterol. 1999 May;94(5):1186-91.

Responsible Party: National University Hospital, Singapore ( Khek Yu Ho / Professor )
Study ID Numbers: D/00/764
Study First Received: November 4, 2008
Last Updated: November 22, 2009
ClinicalTrials.gov Identifier: NCT00786695     History of Changes
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:
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Gastrointestinal Agents
Omeprazole
Enzyme Inhibitors
Gastroesophageal Reflux
Pharmacologic Actions
Esophageal Motility Disorders
Deglutition Disorders
Digestive System Diseases
Therapeutic Uses
Anti-Ulcer Agents
Esophageal Diseases

ClinicalTrials.gov processed this record on February 08, 2010