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

NCT00517270 | Unknown

• 2 other identifiers: EC1932-02HARECCTR0500032
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

Non-cardiac chest pain

Outcome Measures

Primary Outcomes (1)

• Symptoms assessment, quality of life.

  12 Weeks

Secondary Outcomes (2)

• Compliance

  4 Weeks

• Adverse effects

  4 Weeks

Interventions

Rabeprazole 20mg twice daily DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Authority, Hong Kong: lead
• The University of Hong Kong: collaborator

Study Sites (1)

Queen Mary Hospital

Hong Kong, China

RECRUITING

MeSH Terms

Conditions

Chest Pain

Interventions

Rabeprazole

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Ting Kin Cheung, Dr

  Department of Medicine, The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ting Kin Cheung, Dr

CONTACT

(852) 2855 3989; cheungtk@hkucc.hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: August 15, 2007
• First Posted: August 16, 2007
• Study Start: March 1, 2003
• Study Completion: April 1, 2008
• Last Updated: July 7, 2010

Record last verified: 2010-07

Locations

CN (1)