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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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Hospital Authority, Hong Kong.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
The University of Hong Kong
Information provided by:
Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:
NCT00517270
First received: August 15, 2007
Last updated: July 6, 2010
Last verified: July 2010

August 15, 2007
July 6, 2010
March 2003
Not Provided
Symptoms assessment, quality of life. [ Time Frame: 12 Weeks ]
Same as current
Complete list of historical versions of study NCT00517270 on ClinicalTrials.gov Archive Site
  • Compliance [ Time Frame: 4 Weeks ]
  • Adverse effects [ Time Frame: 4 Weeks ]
Same as current
Not Provided
Not Provided
 
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.

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Chest Pain
Drug: Rabeprazole 20mg twice daily
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
April 2008
Not Provided

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.
Both
18 Years and older
Not Provided
Contact: Ting Kin Cheung, Dr (852) 2855 3989 cheungtk@hkucc.hku.hk
China
 
NCT00517270
EC1932-02, HARECCTR0500032
Not Provided
Not Provided
Hospital Authority, Hong Kong
The University of Hong Kong
Principal Investigator: Ting Kin Cheung, Dr Department of Medicine, The University of Hong Kong
Hospital Authority, Hong Kong
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP