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A Study of the Use of High-dose Proton Pump Inhibitor for the Treatment of Gastro-oesophageal Reflux Related Non-cardiac Chest Pain - a Randomized Double-blind Placebo-controlled Study

High-dose Proton Pump Inhibitor for the Treatment of Gastro-oesophageal Reflux Related Non-cardiac Chest Pain - a Randomized Double-blind Placebo-controlled Study.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00517270
Enrollment
200
Registered
2007-08-16
Start date
2003-03-31
Completion date
2008-04-30
Last updated
2010-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chest Pain

Keywords

Non-cardiac chest pain

Brief summary

Non-cardiac chest pain accounts for 2-5% of all emergency presentations. In the United States, it has been estimated approximately that US$8 billion was spent annually for the initial care of patients suspected to have an acute coronary syndrome, but who were subsequently found not to have coronary artery disease (1). The most common cause of non-cardiac chest pain is gastro-oesophageal reflux disease (2). Two randomized, double-blind, placebo-controlled trials on the use of omeprazole versus placebo for the treatment of NCCP have been published in the western population and reported an efficacy of 62% to 80% (3,4). High-dose omeprazole was used in the previous trials (3,4). Recently, it has been shown that rabeprazole, which is a newly developed benzimidazole proton pump inhibitor, is a more potent and rapid inhibitor of H+,K+-ATPase and acid secretion than omeprazole, lansoprazole and pantoprazole (5,6). Whether the above findings applied to Chinese population is unknown. Thus we would like to propose a randomized double-blind placebo-controlled trial to study the effects of high-dose proton pump inhibitor for the treatment of non-cardiac chest pain in Chinese population. The aim of this study is to evaluate the efficacy of high-dose proton pump inhibitor for the treatment of gastro-oesophageal reflux related non-cardiac chest pain.

Interventions

Sponsors

The University of Hong Kong
CollaboratorOTHER
Hospital Authority, Hong Kong
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* Ambulatory patients with age over 18 years old * Patients with chest pain for at least 12 weeks, in the preceding 12 months who are evaluated by cardiac catheterization or exercise radionuclide scan / persantin radionuclide scan will be assessed for suitability to enter the study. Patients will be included if the results of the cardiac investigation are normal.

Exclusion criteria

* Patients with history of significant cardiac, renal, pulmonary or hepatic diseases. * Patients with history of gastrointestinal surgery or peptic ulcer diseases. * Intake of H2 receptor blockers, bismuth or proton pump inhibitors or drugs affecting gastrointestinal motility in the preceding four weeks. * Patients who are pregnant or lactating. * Patients who are suffering from costochrondritis. * Patients who are known to be sensitive to proton pump inhibitor. * Patients with glaucoma and benign prostatic hypertrophy.

Design outcomes

Primary

MeasureTime frame
Symptoms assessment, quality of life.12 Weeks

Secondary

MeasureTime frame
Compliance4 Weeks
Adverse effects4 Weeks

Countries

China

Contacts

Primary ContactTing Kin Cheung, Dr
cheungtk@hkucc.hku.hk(852) 2855 3989

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026