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Clinical Trials/NCT00516971
NCT00516971
Unknown
Not Applicable

The Use of Proton Pump Inhibitor for the Treatment of Non-erosive Gastro-oesophageal Reflux Disease in Chinese Population

Hospital Authority, Hong Kong1 site in 1 country200 target enrollmentJanuary 2003

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gastroesophageal Reflux
Sponsor
Hospital Authority, Hong Kong
Enrollment
200
Locations
1
Primary Endpoint
Symptoms assessment, quality of life.
Last Updated
15 years ago

Overview

Brief Summary

The purpose of this study is to evaluate the efficacy of proton pump inhibitor for the treatment of non-erosive reflux disease (NERD) in Chinese population. Studies from the western population have estimated a worldwide prevalence of gastro-oesophageal reflux disease from 10 to 20 %. Monthly symptoms of heartburn or acid regurgitation were found in 9.3% of subjects according to a population survey in Hong Kong. Most of these patients did not show evidence of erosive change during upper endoscopy. However, patients with NERD suffer from similar impairment of quality of life as patients with erosive oesophagitis and their symptoms are as severe as patients with erosive disease. Data on the use of proton pump inhibitor for the treatment of NERD in Chinese patients are scanty. Thus we want to perform a double-blind randomised placebo-controlled study to evaluate the efficacy of proton pump inhibitor for the treatment of NERD in Chinese population.

Registry
clinicaltrials.gov
Start Date
January 2003
End Date
December 2008
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hospital Authority, Hong Kong

Eligibility Criteria

Inclusion Criteria

  • Ambulatory patients with age between 18 -80 years old,
  • Patients with predominant symptoms of heartburn or acid regurgitation at least once weekly with no evidence of endoscopic pathology.

Exclusion Criteria

  • Patients under 18 or over 80 years of age,
  • Symptoms of gastrointestinal bleeding,
  • Patients who had previous upper gastrointestinal surgery,
  • Patients with concomitant serious medical diseases,
  • Patients who had received H2-receptor antagonists or proton pump inhibitors in the past 4 weeks,
  • Pregnant or lactating women.

Outcomes

Primary Outcomes

Symptoms assessment, quality of life.

Time Frame: 12 Weeks

Secondary Outcomes

  • Compliance(8 Weeks)
  • Adverse effects(8 Weeks)

Study Sites (1)

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