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

Not Applicable

• Conditions: Gastroesophageal Reflux

• Registration Number: NCT00516971
• Lead Sponsor: Hospital Authority, Hong Kong

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-01
• Study First Submitted: 2007-08-15
• Study First Submitted QC: 2007-08-15
• Study First Posted: 2007-08-16
• Study Completion: 2008-12
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-06
• Last Update Posted: 2010-07-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Symptoms assessment, quality of life.	12 Weeks

Secondary Outcome Measures

Name	Time	Method
Compliance	8 Weeks
Adverse effects	8 Weeks

Trial Locations

Locations (1)

Queen Mary Hospital; 🇨🇳 Hong Kong, China