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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

Primary Purpose

Chest Pain

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Rabeprazole 20mg twice daily
Sponsored by
Hospital Authority, Hong Kong
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chest Pain focused on measuring Non-cardiac chest pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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.

Sites / Locations

  • Queen Mary HospitalRecruiting

Outcomes

Primary Outcome Measures

Symptoms assessment, quality of life.

Secondary Outcome Measures

Compliance
Adverse effects

Full Information

First Posted
August 15, 2007
Last Updated
July 6, 2010
Sponsor
Hospital Authority, Hong Kong
Collaborators
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT00517270
Brief Title
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
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 Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
March 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital Authority, Hong Kong
Collaborators
The University of Hong Kong

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Pain
Keywords
Non-cardiac chest pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Rabeprazole 20mg twice daily
Primary Outcome Measure Information:
Title
Symptoms assessment, quality of life.
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
Compliance
Time Frame
4 Weeks
Title
Adverse effects
Time Frame
4 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ting Kin Cheung, Dr
Phone
(852) 2855 3989
Email
cheungtk@hkucc.hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ting Kin Cheung, Dr
Organizational Affiliation
Department of Medicine, The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin CY Wong, Dr

12. IPD Sharing Statement

Learn more about this trial

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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