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

NCT ID: NCT00517270

Last Updated: 2010-07-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-03-31
• Study Completion Date: 2008-04-30

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.

Conditions

Chest Pain

Study Design

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

Interventions

Rabeprazole 20mg twice daily

Intervention Type: DRUG

Eligibility Criteria

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.

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

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: collaborator

Hospital Authority, Hong Kong

OTHER_GOV

Sponsor Role: lead

Principal Investigators

Ting Kin Cheung, Dr

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine, The University of Hong Kong

Locations

Queen Mary Hospital

Hong Kong, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Ting Kin Cheung, Dr

Role: CONTACT

cheungtk@hkucc.hku.hk

(852) 2855 3989

Other Identifiers

HARECCTR0500032

Identifier Type: -

Identifier Source: secondary_id

EC1932-02

Identifier Type: -

Identifier Source: org_study_id