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

Hospital Authority, Hong Kong

Status

Unknown

Conditions

Gastroesophageal Reflux

Treatments

Drug: Esomeprazole 20mg once daily

Study type

Interventional

Funder types

Other

Identifiers

NCT00516971

HARECCTR0500031

EC1925-02

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.