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

November 4, 2008
March 2, 2011
May 2006
December 2009   (final data collection date for primary outcome measure)
symptom resolution [ Time Frame: 14 days of treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00786695 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study Using Esomeprazole as a Diagnostic Test for GERD in Patients With NCCP
Esomeprazole as a Diagnostic Test for Gastroesophageal Reflux Disease in Patients With Noncardiac Chest Pain

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Gastroesophageal Reflux Disease
  • Drug: esomeprazole
    esomeprazole (40 mg o d) for 14 days
    Other Name: nexium
  • Drug: Placebo
    Identical looking Placebo, same regimen, for 14 days
  • Placebo Comparator: Placebo
    Identical looking Placebo
    Intervention: Drug: Placebo
  • Experimental: esomeprazole
    esomeprazole (40 mg o d) for 14 days
    Intervention: Drug: esomeprazole

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
December 2009
December 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT00786695
D/00/764
No
Khek Yu Ho / Professor, National University Hospital, Singapore
National University Hospital, Singapore
Not Provided
Principal Investigator: Khek Yu Ho, MD National University Hospital, Singapore
National University Hospital, Singapore
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP