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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

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ClinicalTrials.gov Identifier: NCT00517270
Recruitment Status : Unknown
Verified July 2010 by Hospital Authority, Hong Kong.
Recruitment status was:  Recruiting
First Posted : August 16, 2007
Last Update Posted : July 7, 2010
Sponsor:
Collaborator:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Chest Pain Drug: Rabeprazole 20mg twice daily

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: High-dose Proton Pump Inhibitor for the Treatment of Gastro-oesophageal Reflux Related Non-cardiac Chest Pain - a Randomized Double-blind Placebo-controlled Study.
Study Start Date : March 2003
Estimated Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chest Pain GERD
Drug Information available for: Rabeprazole
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Symptoms assessment, quality of life. [ Time Frame: 12 Weeks ]

Secondary Outcome Measures :
  1. Compliance [ Time Frame: 4 Weeks ]
  2. Adverse effects [ Time Frame: 4 Weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00517270


Contacts
Contact: Ting Kin Cheung, Dr (852) 2855 3989 cheungtk@hkucc.hku.hk

Locations
China
Queen Mary Hospital Recruiting
Hong Kong, China
Sub-Investigator: Benjamin CY Wong, Dr         
Sponsors and Collaborators
Hospital Authority, Hong Kong
The University of Hong Kong
Investigators
Principal Investigator: Ting Kin Cheung, Dr Department of Medicine, The University of Hong Kong
More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00517270     History of Changes
Other Study ID Numbers: EC1932-02
HARECCTR0500032
First Posted: August 16, 2007    Key Record Dates
Last Update Posted: July 7, 2010
Last Verified: July 2010

Keywords provided by Hospital Authority, Hong Kong:
Non-cardiac chest pain

Additional relevant MeSH terms:
Chest Pain
Gastroesophageal Reflux
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Rabeprazole
Proton Pump Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action