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

NCT ID: NCT00786695

Last Updated: 2011-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2009-12-31

Brief 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.

Conditions

Gastroesophageal Reflux Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Identical looking Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Identical looking Placebo, same regimen, for 14 days

esomeprazole

esomeprazole (40 mg o d) for 14 days

Group Type: EXPERIMENTAL

esomeprazole

Intervention Type: DRUG

esomeprazole (40 mg o d) for 14 days

Interventions

esomeprazole

esomeprazole (40 mg o d) for 14 days

Intervention Type: DRUG

Placebo

Identical looking Placebo, same regimen, for 14 days

Intervention Type: DRUG

Other Intervention Names

nexium

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National University Hospital, Singapore

OTHER

Sponsor Role: lead

Responsible Party

National University Hospital, Singapore

Principal Investigators

Khek Yu Ho, MD

Role: PRINCIPAL_INVESTIGATOR

National University Hospital, Singapore

Locations

National University Hospital

Singapore, , Singapore

Countries

Singapore

References

Ho KY. Gastroesophageal reflux disease is uncommon in Asia: evidence and possible explanations. World J Gastroenterol. 1999 Feb;5(1):4-6. doi: 10.3748/wjg.v5.i1.4. No abstract available.

Reference Type: BACKGROUND

PMID: 11819371 (View on PubMed)

Lim LG, Ho KY. Gastroesophageal reflux disease at the turn of millennium. World J Gastroenterol. 2003 Oct;9(10):2135-6. doi: 10.3748/wjg.v9.i10.2135.

Reference Type: BACKGROUND

PMID: 14562363 (View on PubMed)

Ho KY. Gastroesophageal reflux disease in Asia: a condition in evolution. J Gastroenterol Hepatol. 2008 May;23(5):716-22. doi: 10.1111/j.1440-1746.2008.05380.x.

Reference Type: BACKGROUND

PMID: 18410606 (View on PubMed)

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. doi: 10.1097/MCG.0b013e3180653613.

Reference Type: BACKGROUND

PMID: 18347510 (View on PubMed)

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. doi: 10.1111/j.1440-1746.2006.04341.x.

Reference Type: BACKGROUND

PMID: 16911677 (View on PubMed)

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. doi: 10.1111/j.1440-1746.2005.03887.x.

Reference Type: BACKGROUND

PMID: 15955205 (View on PubMed)

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. doi: 10.1136/gut.43.1.105.

Reference Type: BACKGROUND

PMID: 9771413 (View on PubMed)

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. doi: 10.1111/j.1572-0241.1998.00526.x.

Reference Type: BACKGROUND

PMID: 9772037 (View on PubMed)

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. doi: 10.1046/j.1365-2036.1999.00571.x.

Reference Type: BACKGROUND

PMID: 10468677 (View on PubMed)

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. doi: 10.1111/j.1572-0241.1999.01063.x.

Reference Type: BACKGROUND

PMID: 10235190 (View on PubMed)

Other Identifiers

D/00/764

Identifier Type: -

Identifier Source: org_study_id